MAUDE Adverse Event Report: STRYKER GMBH GAMMA3 - SET SCREW, TI D8X17.5MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	30030822S
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
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
As reported: "the set screws from the gamma nail kit did not hold in the nail.Afterwards, a separately packaged set screw was opened, but this one also did not hold in the nail.Subsequently, a new nail was implanted, and the set screw that came with this nail worked as intended.".
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure.The device inspection revealed the following: the initial couple of threads which make the first contact with the nail threads were found to be damaged.The nylon bush wasn¿t deformed as well hence it could be confirmed that the set screw couldn¿t be inserted at all inside the nail, most likely due to cross threading.Since the threads of both the nail & the set screw were majorly deformed, the issue could be confirmed.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Based on available information, the root cause of issue is deemed to be user related.The cross threading between the screw is indicative of the fact that the screw wasn¿t aligned properly with the threads in the nail, leading impaired insertion.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "the set screws from the gamma nail kit did not hold in the nail.Afterwards, a separately packaged set screw was opened, but this one also did not hold in the nail.Subsequently, a new nail was implanted, and the set screw that came with this nail worked as intended.".

• Brand Name: GAMMA3 - SET SCREW, TI D8X17.5MM
• 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: 23991424
• Report Number: 0008031020-2026-00013
• Device Sequence Number: 10503335
• Product Code: HSB
• UDI-Device Identifier: 04546540374844
• UDI-Public: 04546540374844
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K200869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2026

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: 30030822S
• Device Lot Number: K12BB2D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2025
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown