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

Catalog Number	14200110
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: " in (b)(6) hospital (b)(6) we were doing a case and the k wire didn't line up with the rotation of the jig." the surgery was completed successfully by opening a second set and using the jig.There was 30 min of delay.
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could not be confirmed during the investigation, no device malfunction could be observed.The device inspection revealed the following: the identification of the returned targeting sleeve could be confirmed.No major signs of wear or damage, impairing the device's functionality, could be observed.The returned target sleeve and proximal targeting arm were tested with fully functional gamma-4 nail and lag screw drill samples.The devices were successfully assembled and no problems were identified.The lag screw drill could be correctly centered in the lag screw hole of the nail.The reported misdrilling was not observed, and it was confirmed that the returned instruments are fully functional.Given the device were confirmed to be fully functional, the root cause of the reported event could not be determined.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.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: " (b)(6) we were doing a case and the k wire didn't line up with the rotation of the jig." the surgery was completed successfully by opening a second set and using the jig.There was 30 min of delay.

• Brand Name: GAMMA4 - TARGETING SLEEVE
• 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 KIEL; 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: 22287868
• Report Number: 0008031020-2025-00984
• Device Sequence Number: 15683805
• Product Code: HSB
• UDI-Device Identifier: 07613327479911
• UDI-Public: 07613327479911
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K213328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2025

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: 14200110
• Device Lot Number: KP505780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/22/2025
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/16/2023
• 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 Age: 26 YR
• Patient Sex: Female