Consumers and health professionals are advised that Synthes Australia, in consultation with the TGA, is recalling unused stock of its 3.7 mm and 5.0 mm Dynamic Locking Screws. Synthes Australia has also issued a related hazard alert to hospitals and surgeons.
Dynamic Locking Screws are used with an orthopaedic fixation plate to treat fractures of long bones.
It has been identified that the distal tip (the end furthest from the head) of the 3.7 mm and 5.0 mm Dynamic Locking Screws can potentially break.
If this occurs, it could increase the time in surgery needed to remove the screws and could result in injury to the patient, such as soft tissue damage. While unlikely, a breakage could require additional surgery.
There have been no adverse events relating to this issue reported in Australia.
The part numbers for the affected products are:
- 09.213.022S–09.213.070S for Dynamic Locking Screws 3.7 mm (all lots)
- 09.223.032S–09.223.090S for Dynamic Locking Screws 5.0 mm (all lots)
Information for consumers
Synthes Australia has contacted surgeons and the hospitals where the affected Dynamic Locking Screws have been used, providing further information regarding this recall and advice on how to treat affected patients.
If you have had an orthopaedic fixation plate implanted to treat a fracture of a long bone and have any questions or concerns about this issue, contact your surgeon or the hospital where the surgery was undertaken.
Information for all health professionals
Patients who have had an orthopaedic fixation plate implanted to treat a fracture of a long bone and who have any questions or concerns about the above issue should be referred to their surgeon or to the hospital where the surgery was undertaken.
Information for surgeons and hospitals
Synthes Australia has contacted surgeons and the hospitals where the affected Dynamic Locking Screws have been used, providing further information regarding this issue, including advice on how to treat affected patients and details of the recall process.
Surgeons and hospitals should check any unused Dynamic Locking Screws they have in stock to see if any are affected by this recall. If they are, those screws should not be used. Instead, they should be quarantined before being returned to Synthes Australia.
Patients who have already had procedures in which 3.7 mm and/or 5.0 mm Dynamic Locking Screws were used should be followed up in accordance with the surgeon's/hospital's routine protocols and assessed for any signs or symptoms that may be related to this issue.
If this evaluation leads to a decision to remove the implant, contact your local Synthes Australia Trauma sales representative for the required instrumentation for removal.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.