MAUDE Adverse Event Report: STRYKER GMBH GAMMA4 - RC LAG SCREW D10.5X95MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	81660095S
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "after performing a calibration check and inserting the gamma long nail according to the manual, the lag screw was inserted.When attempting to attach the u-guide to the lag screw, it could not be attached.The surgeons confirmed with x-rays that the lag screw itself had slipped out of the lag screw hole and was inserted through the front of the nail.(after inserting the nail, the nail was retightened with a ball-tip screwdriver, and a calibration check was also performed before insertion.All procedures were performed according to the manual, and the precision pin was also inserted in the correct order through the sleeve before performing the lag screw drill.) the lag screw that could not be inserted in the correct position was removed.After slightly deepening the nail, the precision pin was reinserted, and it entered while interfering with the lag screw hole of the nail.The lag screw drill was also re-drilled while interfering with the lag screw hole.After that, the removed lag screw was reinserted, and the operation was completed.Although the connection is unclear, when the precision pin was first inserted and drilling was performed, there was a bone fragment protruding forward, so the surgeon used an elevator to hold the bone fragment in place from the front.After the surgery, the sales representatives inspected the instruments, but no problems were found.".
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.The provided images do not allow to confirm any mispositioning or insertion impaired during the procedure.The provided images and available information were forwarded to medical affairs, with the following review: the image does not allow to confirm the event.Something went wrong from the start, or the guidewire was retracted after the drilling an reinserted in a wrong direction.Clearly procedures were not followed and checked.A review of the device history for the reported lot did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.Based on investigation, the root cause was attributed to a user-related issue, likely due to deviations from the recommended procedure during the steps leading up to the insertion of the lag screw.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "after performing a calibration check and inserting the gamma long nail according to the manual, the lag screw was inserted.When attempting to attach the u-guide to the lag screw, it could not be attached.The surgeons confirmed with x-rays that the lag screw itself had slipped out of the lag screw hole and was inserted through the front of the nail.(after inserting the nail, the nail was retightened with a ball-tip screwdriver, and a calibration check was also performed before insertion.All procedures were performed according to the manual, and the precision pin was also inserted in the correct order through the sleeve before performing the lag screw drill.) the lag screw that could not be inserted in the correct position was removed.After slightly deepening the nail, the precision pin was reinserted, and it entered while interfering with the lag screw hole of the nail.The lag screw drill was also re-drilled while interfering with the lag screw hole.After that, the removed lag screw was reinserted, and the operation was completed.Although the connection is unclear, when the precision pin was first inserted and drilling was performed, there was a bone fragment protruding forward, so the surgeon used an elevator to hold the bone fragment in place from the front.After the surgery, the sales representatives inspected the instruments, but no problems were found.".

• Brand Name: GAMMA4 - RC LAG SCREW D10.5X95MM
• 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: 22848757
• Report Number: 0008031020-2025-01401
• Device Sequence Number: 8421846
• Product Code: HSB
• UDI-Device Identifier: 07613327591927
• UDI-Public: (01)07613327591927(17)350228(10)K1123A6
• 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): 11/06/2025

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: 81660095S
• Device Lot Number: K1123A6
• 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: 07/24/2025
• Supplement Date Received by Manufacturer: 10/09/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 11/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/10/2025
• 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: Other
• Patient Age: 83 YR
• Patient Sex: Male