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	Perforation (2001)
Date of Event	02/10/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Event or Problem Description
As reported: on (b)(6) 2025, primary surgery with gamma4 was performed.After surgery, a cut-out of the u-lag screw occurred, and screw removal surgery was performed.During the procedure, it was found that the blade of the u-lag screw was bent outward.
Event or Problem Description
As reported: on (b)(6) 2025, primary surgery with gamma4 was performed.After surgery, a cut-out of the u-lag screw occurred, and screw removal surgery was performed.During the procedure, it was found that the blade of the u-lag screw was bent outward.
Additional Manufacturer Narrative
In spite of the product being returned, the reported event could not be confirmed since post operative x rays showing cut out are missing.The device inspection revealed the following: as received, the lag screw u blade is found in deformed condition ie one blade is found bent outwards.The bent portion of the blade shows severe rubbing marks.Corresponding to the damages in the u blade, the flutes of the lag screw where this blade sits also shows signs of damage.There are two marks of set screw fixation in the groove of lag screw.It cannot be confirmed whether all this has happened during procedure or during explantation or at any specific point of time during healing period since intra operative and periodic post operative x rays are not provided.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.No product related issue could be detected during the performed investigation of the returned device.Regarding the root cause of the event no conclusive statement can be provided, because key clinical information eg x rays in different planes, clinical status, patient activity, assessment of the treating physician or operation reports is missing.If more information is provided, the case will be reassessed.

• 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 TRAUMA GMBH; 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: 24676667
• Report Number: 0008031020-2026-00449
• Device Sequence Number: 16006158
• Product Code: HSB
• 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: Distributor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2026

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: Lay User/Patient
• Device Catalogue Number: 81660085S
• Device Lot Number: K14EC04
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/13/2026
• Supplement Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 06/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2025
• 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: Required Intervention
• Patient Sex: Unknown