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

Catalog Number	82250240S
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.
Event or Problem Description
As reported; "miss target occurred during drilling for inserting the screw to the distal oval hole of gamma4 nail.The screw was once removed, freehand drilling was performed, and screw was reinserted.The surgery was completed successfully after that while there was about 10 minutes delay.The surgeon is aware of the fact that there is no problem with the devices because a functional check of the nail and the targeting device was performed prior to insertion of the nail into the patient's body.".
Additional Manufacturer Narrative
The reported event could not be confirmed since the affected device was not returned and no evidence was provided for evaluation.A device inspection was not possible since the affected device was not returned.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.Indications of material, manufacturing or design related problems were unable to be identified as the lot number was not communicated.A review of the labelling did not indicate any abnormalities.More information, as well as the affected device, must be available in order to determine the exact root cause of the issue.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported; "miss target occurred during drilling for inserting the screw to the distal oval hole of gamma4 nail.The screw was once removed, freehand drilling was performed, and screw was reinserted.The surgery was completed successfully after that while there was about 10 minutes delay.The surgeon is aware of the fact that there is no problem with the devices because a functional check of the nail and the targeting device was performed prior to insertion of the nail into the patient's body.".

• 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 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: 23097697
• Report Number: 0008031020-2025-01608
• Device Sequence Number: 12933128
• Product Code: HSB
• UDI-Device Identifier: 07613327593723
• UDI-Public: (01)07613327593723(17)350630(10)K1326D9
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K230512
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2025

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: 82250240S
• Device Lot Number: K1326D9
• 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: 08/27/2025
• Supplement Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/23/2025
• 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: 86 YR
• Patient Sex: Female
• Patient Weight: 34 KG