MAUDE Adverse Event Report: STRYKER GMBH GAMMA4 - INTERMEDIATE NAIL, RIGHT D10X240MM X 125DEG; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	82250240S
Medical Device Problem Codes	Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: "an intermediate nail for right was inserted on the left side incorrectly.During the lateral fixation drilling, the left-right reversal was noticed.It was suggested to swap the nail, however, due to concerns about reduced fixation strength from swapping the lag screws, the doctor decided not to swap them.Instead, lateral fixation screws were inserted, and the procedure was completed.".
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a 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.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.There was no allegation against the product, the labelling or distribution reported, therefore the event can be classified as user related.In general following statement of the he gamma4 implants instructions for use can be pointed out in relation to this event: " the licensed healthcare professional¿s education, training and professional judgment must be relied upon to choose the most appropriate device and treatment.They should warn patients about these contraindications and limitations when appropriate.Implant selection and sizing: the correct selection of the fracture fixation appliance is extremely important.Failure to use the appropriate appliance for the fracture condition may accelerate clinical failure.Failure to use the proper component to maintain adequate blood supply and provide rigid fixation may result in loosening, bending, cracking or fracture of the device and/or bone.The correct implant size for a given patient can be determined by evaluating the patient¿s height, weight, functional demands and anatomy.Every implant must be used in the correct anatomic location, consistent with accepted standards of internal fixation." if more information is provided, the case will be reassessed.
Event or Problem Description
As reported: "an intermediate nail for right was inserted on the left side incorrectly.During the lateral fixation drilling, the left-right reversal was noticed.It was suggested to swap the nail, however, due to concerns about reduced fixation strength from swapping the lag screws, the doctor decided not to swap them.Instead, lateral fixation screws were inserted, and the procedure was completed.".

• Brand Name: GAMMA4 - INTERMEDIATE NAIL, RIGHT D10X240MM 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: 23861059
• Report Number: 0008031020-2025-02193
• Device Sequence Number: 13167396
• Product Code: HSB
• UDI-Device Identifier: 07613327593723
• UDI-Public: (01)07613327593723(17)350930(10)K14848F
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K230512
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

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: 82250240S
• Device Lot Number: K14848F
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2025
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 12/21/2025
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/05/2025
• 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
• Patient Age: 87 YR
• Patient Sex: Female