MAUDE Adverse Event Report: STRYKER GMBH CANNULATED SCREW, PARTIALLY THREADED ASNIS III Ø4.0X60MM TL20MM; SCREW, FIXATION, BONE

Catalog Number	604660S
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that: "patient operated on (b)(6) 2024 for a bimalleolar fracture with insertion of two stryker screws ref.604660s batch k31308 and one plate ref.40-20903s batch 1000591836.Several orthopedic consultations, including on (b)(60 2024 "material visible to the naked eye and infection on material" proposal to remove the material; last consultation on (b)(6) 2025 with scheduling of outpatient removal (infection was controlled between the previous consultation and the last one with traceability of complex dressings).(please refer to complaints (b)(4) on (b)(6) 2025, removal in day hospital in accordance with decision; (please refer to complaints (b)(4).During explantation of the material incomplete, a screw broke in the bone of the malleolus during its extraction.A piece of the screw could not be removed and remains in the tissue.
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Event or Problem Description
The customer reported that: "patient operated on (b)(6) 2024 for a bimalleolar fracture with insertion of two stryker screws ref.604660s batch k31308 and one plate ref.40-20903s batch 1000591836.Several orthopedic consultations, including on (b)(6) 2024 "material visible to the naked eye and infection on material." proposal to remove the material; last consultation on (b)(6) 2025 with scheduling of outpatient removal (infection was controlled between the previous consultation and the last one with traceability of complex dressings).(please refer to complaints (b)(4)).On (b)(6) 2025, removal in day hospital in accordance with decision; (please refer to complaints (b)(4)).During explantation of the material incomplete, a screw broke in the bone of the malleolus during its extraction.A piece of the screw could not be removed and remains in the tissue.
Additional Manufacturer Narrative
The reported event could be confirmed based on the device inspection.The device inspection revealed the following: the returned is broken apart at the shaft, it is visible that the screw was bent before it broke.The hexagon is flattened and worn out.The fracture surface appears irregular and rough, with visible signs of deformation around the edges which is characteristic of a ductile fracture.The fact that the screw is bent supports this observation, as it indicates the material was bent under applied stress (likely excessive torsional force during removal) prior to breaking.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 a user-related issue.The event was caused by excessive torsional stress applied to the screw during its removal.If more information is provided, the case will be reassessed.

• Brand Name: CANNULATED SCREW, PARTIALLY THREADED ASNIS III Ø4.0X60MM TL20MM
• Common Device Name: SCREW, 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: 23418095
• Report Number: 0008031020-2025-02016
• Device Sequence Number: 13357351
• Product Code: HWC
• UDI-Device Identifier: 04546540089908
• UDI-Public: (01)04546540089908(17)270331(10)K31308
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K220319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2026

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: 604660S
• Device Lot Number: K31308
• 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: 10/03/2025
• Supplement Date Received by Manufacturer: 12/22/2025
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2022
• 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 Age: 78 YR
• Patient Sex: Female