MAUDE Adverse Event Report: STRYKER GMBH GAMMA4 - LAG SCREW D10.5X100MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Catalog Number	81600100S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	08/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported: "the initial surgery took place on (b)(6) 2025, xray image was then taken on (b)(6) 2025, issue was found that the shs migrated medially.Each operation was performed by a different doctor/clinical team; revision surgery performed on (b)(6) 2025.Re-revision surgery planned for (b)(6) 2025." this complaint captures the 2nd planned revision.
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, but available radiograph confirms the alleged event.The devices received were inspected, and we can see deformation marks and hitting marks on all the devices.In the lag screw, we can see heavy deformation just above the groove, which could be from explantation.The set screw tightening mark was visible in the groove as well as the sliding of the set screw till the end of the groove, indicating the possibility of loosening of the set screw more than the requirement of ¼ of a turn.We also see thread damage in the proximal locking screw.Heavy deformation on all devices could be caused by the explanation of the devices.With the available radiograph, a formal medical opinion was sought: we see a basicervical fnf here.The positioning of the nail and the lag screw is not optimal, but good.However, these fractures have an increased risk of failure due to the mismatch between the diameter of the cortical bone of the proximal and distal fragments, leading to an inherent instability.This specific fracture pattern provides the lag screw with a pretty high force in the medial direction, which is visible here.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.The operative techniques states that: ¿do not unscrew the set screw more than ¼ of a turn.Insufficient contact between lag screw and set screw could lead to loss of fixation and post-operative complications.¿ no indications of material, manufacturing or design related problems were found during the investigation.Based on the available information, the root cause is a multifactorial combination of user related and patient-related factors, as we can see signs of the set screw sliding in the groove, indicating towards the possibility of loosening of the set screw more than the requirement of ¼ of a turn which is more than specified in operative technique and the traction forces generated by mobilization acting on the lag screw exceeded the fixation provided by the set screw.If any additional information is provided, the investigation will be reassessed.
Event or Problem Description
As reported: "the initial surgery took place on (b)(6) 2025, xray image was then taken on (b)(6) 2025, issue was found that the shs migrated medially.Each operation was performed by a different doctor/clinical team; revision surgery performed on (b)(6) 2025.Re-revision surgery planned for (b)(6) 2025." this complaint captures the 2nd planned revision.

• Brand Name: GAMMA4 - LAG SCREW D10.5X100MM
• 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: 23342886
• Report Number: 0008031020-2025-01984
• Device Sequence Number: 18078319
• Product Code: HSB
• UDI-Device Identifier: 07613327510997
• UDI-Public: (01)07613327510997(17)341231(10)K1023A5
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K213328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2026

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: 81600100S
• Device Lot Number: K1023A5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/23/2025
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2025
• 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