MAUDE Adverse Event Report: STRYKER GMBH GAMMA4 - LONG NAIL, LEFT D10X300MM X 125DEG; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	85250300S
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "the surgeon picked up the nail for left for right intertrochanteric femur fracture by mistake as both right nails and left nails were stocked in the same box.The surgeon noticed it when the x-ray was taken during insertion of the distal locking screw.After realizing the mistake, the nail was removed and replaced with another one, and the surgery was completed.The fracture was firmly fixed, and there are currently no reports of any health problems to the patient while the procedure took approximately 15 minutes longer.".
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Additional Manufacturer Narrative
The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.However, based on the provided information in the event description, the root cause of the complaint event is user related since the reported issue was human error and there was no product defect reported.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.Indications of material, manufacturing, or design related problems were unable to be identified as the catalog number and lot number were not communicated.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "the surgeon picked up the nail for left for right intertrochanteric femur fracture by mistake as both right nails and left nails were stocked in the same box.The surgeon noticed it when the x-ray was taken during insertion of the distal locking screw.After realizing the mistake, the nail was removed and replaced with another one, and the surgery was completed.The fracture was firmly fixed, and there are currently no reports of any health problems to the patient while the procedure took approximately 15 minutes longer.".

• Brand Name: GAMMA4 - LONG NAIL, LEFT D10X300MM 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 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: 23417263
• Report Number: 0008031020-2025-02009
• Device Sequence Number: 8929268
• Product Code: HSB
• UDI-Device Identifier: 07613327474725
• UDI-Public: (01)07613327474725(11)250207(17)350131(10)K103B71
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K213328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2026

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: 85250300S
• Device Lot Number: K103B71
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/02/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2025
• 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: Female