MAUDE Adverse Event Report: STRYKER GMBH GAMMA4 - RC LAG SCREW D10.5X85MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	81660085S
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.Should additional information become available, it will be provided in a supplemental report.
Event or Problem Description
It was reported that the blade was inserted incorrectly and bent.
Additional Manufacturer Narrative
Correction to d9 (product available to stryker), h3 (device evaluated by mfg), and h6 (health impact code).The reported event could be confirmed during the investigation.The device inspection revealed the following: the identification of the returned lag screw and blade could be confirmed based on the catalog number and lot number marked on the packaging label.One arm of the blade is highly bent, confirming the reported event.The tips of both devices are damaged as a result of the failed insertion attempt.Dimensional inspection showed that the blade is within specification.Based on the information received ("inserted the blade incorrectly and bent it") the root cause could be determined as user related.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.If more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that the blade was inserted incorrectly and bent.

• Brand Name: GAMMA4 - RC LAG SCREW D10.5X85MM
• Common Device Name: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 24040485
• Report Number: 0008031020-2026-00024
• Device Sequence Number: 9139973
• Product Code: HSB
• UDI-Device Identifier: 07613327591798
• UDI-Public: (01)07613327591798(17)350930(10)K14FC3C
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 03/24/2026

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: 81660085S
• Device Lot Number: K14FC3C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2025
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 03/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2025
• 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