MAUDE Adverse Event Report: STRYKER GMBH GAMMA4 - PROXIMAL TARGETING ARM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	14200100
Medical Device Problem Codes	Device Difficult to Setup or Prepare (1487); Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Event or Problem Description
It was reported that since converting to gamma4 instruments from gamma3, dr potter and his group have observed that the treads of the strike plate appear to loosen more than what has been observed tilt the gamma 3 targeter/strike plate.They have observed that targeters have had damaged threads because they have been impacted whilst not fully seated.The hypothesis is that the strike plate is loosening during impaction, and then impacted while loose thereby damaging the threads in the targeter.In addition to the strike plate/targeter thread damage, dr potter has observed that the nail holding bolt has also become loose during nail insertion more than experienced with gamma 3 instrumentation requiring re-tightening of the nail holding bolt during insertion.The loosening of the nail holding bolt has caused the lag screw/distal locking screw to miss the nail because of loosing of the nail holding bolt.15 min delay to perform manual targeting/re-tightening of the nail holding bolt.
Event or Problem Description
It was reported that since converting to gamma4 instruments from gamma3, dr (b)(6) and his group have observed that the treads of the strike plate appear to loosen more than what has been observed tilt the gamma 3 targeter/strike plate.They have observed that targeters have had damaged threads because they have been impacted whilst not fully seated.The hypothesis is that the strike plate is loosening during impaction, and then impacted while loose thereby damaging the threads in the targeter.In addition to the strike plate/targeter thread damage, dr (b)(6) has observed that the nail holding bolt has also become loose during nail insertion more than experienced with gamma 3 instrumentation requiring re-tightening of the nail holding bolt during insertion.The loosening of the nail holding bolt has caused the lag screw/distal locking screw to miss the nail because of loosing of the nail holding bolt.15 min delay to perform manual targeting/re-tightening of the nail holding bolt.
Additional Manufacturer Narrative
Correction: please refer to section d9 the device was not returned.The reported event could not be confirmed since the device was not returned for evaluation, but with the provided issue alleged event can¿t be replicated.With the provided picture, we can only see the slight damage on the assembly thread, but without the returned product and functional inspection could not be analyzed.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: GAMMA4 - PROXIMAL TARGETING ARM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER TRAUMA GMBH; prof. kuentscher-strasse 1-5; schoenkirchen/kiel D-242 32; GM D-24232
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23840358
• Report Number: 0008031020-2025-02189
• Device Sequence Number: 13251368
• Product Code: HSB
• UDI-Device Identifier: 07613327479904
• UDI-Public: (01)07613327479904(10)K1C7A74
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K213328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 14200100
• Device Lot Number: RA960052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/24/2025
• Supplement Date Received by Manufacturer: 01/08/2026; 04/30/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 02/05/2026; 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown