MAUDE Adverse Event Report: STRYKER GMBH DISTAL LATERAL FIBULA PLATE, 3 HOLE, STERILE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	40-20903S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Medical device site infection (4845)
Date of Event	10/02/2025
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
The customer reported that: "patient operated on (b)(6) 2024 for a bimalleolar fracture with insertion of two stryker screws ref.(b)(4) batch k31308 and one plate ref.(b)(4) 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).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.(please refer to pi (b)(4)).
Additional Manufacturer Narrative
Correction: please refer to section d9 the device was not returned.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences that could have confirmed the infection (such as medical records, infection test results.) were provided for investigation.Therefore, the reported event could not be confirmed.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.Sterilization documents of this lot were reviewed by a sterility specialist.It was confirmed that the process was done according to all requirements.It must also be highlighted that no similar complaint has been reported for this lot.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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.(b)(4) batch k31308 and one plate ref.(b)(4) 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).On (b)(6) 2025, removal in day hospital in accordance with decision; (please refer to complaints (b)(4) and (b)(4)).During explantation of the material incomplete, a screw broke in the bone of the malleolus during its extraction.(please refer to (b)(4)).

• Brand Name: DISTAL LATERAL FIBULA PLATE, 3 HOLE, STERILE
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; postfach; freiburg D-791 11; GM D-79111
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23417732
• Report Number: 0008031020-2025-02012
• Device Sequence Number: 9085219
• Product Code: KTT
• UDI-Device Identifier: 04546540604613
• UDI-Public: (01)04546540604613(17)290605(10)1000561836
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K081284
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 40-20903S
• Device Lot Number: 1000591836
• Was Device Available for Evaluation?: No
• 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): No
• Date Device Manufactured: 06/06/2024
• 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 Age: 78 YR
• Patient Sex: Female