MAUDE Adverse Event Report: STRYKER GMBH GAMMA3 - U-BLADE SET, TI D10.5X80MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	30660080S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	09/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested and if received, will be provided in the supplemental report.
Event or Problem Description
As reported: "the u-lag screw in a patient who received a gamma 3 implant during surgery on (b)(6) 2023, became cut out.After the gamma 3 was extracted, mdm's artificial head was replaced.".
Event or Problem Description
As reported: "the u-lag screw in a patient who received a gamma 3 implant during surgery on (b)(6) 2023, became cut out.After the gamma 3 was extracted, mdm's artificial head was replaced.".
Additional Manufacturer Narrative
The device has not been returned.The lag screw cut out could be confirmed by x-ray and 3d images received.Based on investigation, the root cause was attributed to a patient related issue.The images show that the femoral had and neck collapsed over the system.As a reminder, a cut-out is due to a patient condition, and it is when the bone of the patient is not able to hold the femur neck in position over the implant structure.There were no indications of screw migration or of an medical related issue.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.

• Brand Name: GAMMA3 - U-BLADE SET, TI D10.5X80MM
• 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: 23184815
• Report Number: 0008031020-2025-01648
• Device Sequence Number: 18660859
• Product Code: HSB
• UDI-Device Identifier: 04546540595966
• UDI-Public: (01)04546540595966(11)211020(17)260930(10)K0CB432
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K200869
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2025

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/30/2026
• Device Catalogue Number: 30660080S
• Device Lot Number: K0CB432
• 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: 09/02/2025
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 09/30/2025
• Supplement Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/20/2021
• 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: Required Intervention
• Patient Sex: Unknown