MAUDE Adverse Event Report: STRYKER GMBH GAMMA4 - TROCHANTERIC NAIL 170MM D10X170MM X 125DEG; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	81250170S
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
As reported: "a mis-drill occurred during distal locking.Preoperative target accuracy check showed no problems.".

• Brand Name: GAMMA4 - TROCHANTERIC NAIL 170MM D10X170MM 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: 24661507
• Report Number: 0008031020-2026-00440
• Device Sequence Number: 14716287
• Product Code: HSB
• UDI-Device Identifier: 07613327479058
• UDI-Public: (01)07613327479058(17)350731(10)K13A53D
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K213328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2026

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: 81250170S
• Device Lot Number: K13A53D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/16/2026
• Supplement Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/09/2025
• 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