MAUDE Adverse Event Report: STRYKER GMBH GAMMA3 - U-BLADE LAG SCREWDRIVER; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	13200310
Medical Device Problem Codes	Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: primary g3 surgery was performed on (b)(6) 2015.The patient fell and re-fractured the bone at under the u-lag screw of g3.Revision surgery for removing g3 and replacing long nail was performed on (b)(6) 2025.During surgery, the tip of the t-handle became bent due to the hardness of the bone during removal.This record covers the bent t-handle.".
Additional Manufacturer Narrative
Once the investigation is completed any additional information will be reported in a supplemental report.
Additional Manufacturer Narrative
The reported event could be confirmed since the device was returned for evaluation and matches the alleged failure.The device inspection revealed the following: during visual inspection of the received u-blade lag screwdriver, pegs of the screwdriver found bent.The deformation of the pegs suggests that an excess torsional force has been applied in the anticlockwise direction due to which its tip has got slightly tilted.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required currently.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.The event was caused by the application of excess torsional force during explantation.If more information is provided, the case will be reassessed.
Event or Problem Description
As reported: primary g3 surgery was performed on (b)(6) 2015.The patient fell and re-fractured the bone at under the u-lag screw of g3.Revision surgery for removing g3 and replacing long nail was performed on (b)(6) 2025.During surgery, the tip of the t-handle became bent due to the hardness of the bone during removal.This record covers the bent t-handle.".

• Brand Name: GAMMA3 - U-BLADE LAG SCREWDRIVER
• 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: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22287634
• Report Number: 0008031020-2025-00981
• Device Sequence Number: 8921619
• Product Code: HSB
• UDI-Device Identifier: 04546540377845
• UDI-Public: (01)04546540377845(10)K18B2B5
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K032244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2025

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: 13200310
• Device Lot Number: K18B2B5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/21/2025
• Supplement Date Received by Manufacturer: 07/21/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/20/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian