MAUDE Adverse Event Report: STRYKER GMBH LOCKING SCREW ANCHORAGE Ø3.5MM / L16MM; PLATE, FIXATION, BONE

Catalog Number	PLSL3516
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "when removing the lisfranc plate, the heads of the screws break 3.5 mm.".
Additional Manufacturer Narrative
Based on the available information the device will not be returned therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided in a supplemental report.
Additional Manufacturer Narrative
Correction to h3(device evaluated by mfg) and h6(device code).The reported event could not be confirmed since the device was returned for evaluation and was observed to be deformed, not broken.The returned screw was visually inspected, revealing notable deformation of the torx recess on the screw head, which appeared completely distorted due to the application of excessive force.Prominent scratch marks were observed on the screw head, along with a shiny wear surface beneath the head.These marks indicate that the sides of the screw contacted the implant plate, suggesting that the screw was inserted under misalignment.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.Based on investigation, the root cause was attributed to be user related.If more information is provided, the case will be reassessed.
Event or Problem Description
It was reported that "when removing the lisfranc plate, the heads of the screws break 3.5 mm.".

• Brand Name: LOCKING SCREW ANCHORAGE Ø3.5MM / L16MM
• Common Device Name: PLATE, FIXATION, BONE
• 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: 23720327
• Report Number: 0008031020-2025-02130
• Device Sequence Number: 8835583
• Product Code: HRS
• UDI-Device Identifier: 07613252262350
• UDI-Public: (01)07613252262350(10)AM5755
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K083447
• 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): 02/17/2026

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: PLSL3516
• Device Lot Number: AM5755
• 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: 11/07/2025
• Supplement Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 02/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2025
• 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: Unknown