MAUDE Adverse Event Report: STRYKER GMBH GAMMA3 - SPEEDLOCK SLEEVE 200; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	13201120
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	08/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "g3 200 speedlock sleeve no longer sits correctly on the insertion guide, resulting in an increased number of incorrect holes when positioning the k-wire for the femoral neck screw and the distal locking screw.In some cases, it is no longer possible to fully fix the guide sleeves.".
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.The device inspection revealed the following: the identification of the returned speedlock sleeve could be confirmed based on the catalog # and lot # marked.No major signs of damage impairing the device's functionality could be observed.The returned speedlock sleeve was tested with fully functional target device, nail and tissue protection sleeves.The assembly could be performed as required when testing both the lag screw hole and the distal locking hole.The reported misdrilling was not observed.Therefore, it could be confirmed that the returned speedlock sleeve is fully functional.Given the device is fully functional, the root cause of the alleged misdrilling 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: "g3 200 speedlock sleeve no longer sits correctly on the insertion guide, resulting in an increased number of incorrect holes when positioning the k-wire for the femoral neck screw and the distal locking screw.In some cases, it is no longer possible to fully fix the guide sleeves.".

• Brand Name: GAMMA3 - SPEEDLOCK SLEEVE 200
• 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: 22893596
• Report Number: 0008031020-2025-01426
• Device Sequence Number: 5828264
• Product Code: HSB
• UDI-Device Identifier: 07613154893669
• UDI-Public: 07613154893669
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K123401
• 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): 11/05/2025

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: 13201120
• Device Lot Number: KP309436
• 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: 08/01/2025
• Supplement Date Received by Manufacturer: 10/10/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2010
• 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