MAUDE Adverse Event Report: STRYKER GMBH GAMMA3 - TROCHANTERIC NAIL KIT, TI D11X180MM X 125DEG; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	31251180S
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Codes	Pain (1994); Perforation (2001)
Date of Event	11/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported by the customer: "when inserting the short titanium gamma nail, it was impossible to lock it in place statically due to friction on the nail; therefore, it had to be locked dynamically, resulting in a high risk of the distal screw breaking when the patient put weight on her leg.On the same nail, the slide for inserting the cephalic screw locking screw became misaligned leading to slippage when aiming.The screw ended up in the patient's buttock and could not be removed.A second prosthesis was opened and presented the same problem." update (b)(6) 2026 was the procedure completed successfully? yes, but the nail was stabilized distally in a dynamic position.The patient reports postoperative pain at the screw site.Was the procedure delayed? yes: 10 minutes of additional operating time.
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
As reported by the customer: "when inserting the short titanium gamma nail, it was impossible to lock it in place statically due to friction on the nail; therefore, it had to be locked dynamically, resulting in a high risk of the distal screw breaking when the patient put weight on her leg.On the same nail, the slide for inserting the cephalic screw locking screw became misaligned leading to slippage when aiming.The screw ended up in the patient's buttock and could not be removed.A second prosthesis was opened and presented the same problem." update february 26, 2026 was the procedure completed successfully? yes, but the nail was stabilized distally in a dynamic position.The patient reports postoperative pain at the screw site.Was the procedure delayed? yes: 10 minutes of additional operating time.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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 any further information is provided, the investigation report will be reassessed.

• Brand Name: GAMMA3 - TROCHANTERIC NAIL KIT, TI D11X180MM X 125DEG
• 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: 24654239
• Report Number: 0008031020-2026-00435
• Device Sequence Number: 5726272
• Product Code: HSB
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K034002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 31251180S
• Device Lot Number: K13BCF1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/12/2026
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 05/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/05/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female
• Patient Weight: 176 LB