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

Catalog Number	14200100
Medical Device Problem Code	Failure to Align (2522)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The following information was reported: "several advanced gamma surgeons have since the introduction of gamma 4 experienced issues with the distal screw which misses the troch nail." this record covers surgery 3 out of 3.
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 since the alleged failure was not reproduced during functional testing.The device inspection revealed the following: targeting arm was received and the device shows normal signs of usage.No damage or deformation was observed with respect to the failure a functional inspection was done on the returned targeting arm using a sample nail, tissue protection sleeve, drill sleeve and drill in which it was found that the drill is easily passing through the distal hole of the nail.Therefore, the device is functional, and the event is not confirmed.Given the device was 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
The following information was reported: "several advanced gamma surgeons have since the introduction of gamma 4 experienced issues with the distal screw which misses the troch nail." this record covers surgery 3 out of 3.

• 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 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: 23695000
• Report Number: 0008031020-2025-02114
• Device Sequence Number: 21130576
• Product Code: HSB
• UDI-Device Identifier: 07613327479904
• UDI-Public: (01)07613327479904(10)K1DF951
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K213328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2026

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: RA974023
• 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: 11/03/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2024
• 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