MAUDE Adverse Event Report: SYNTHES GMBH FIBULINK® SYNDESMOSIS REPAIR KIT/ TI; WASHER, BOLT NUT

Catalog Number	FGS-1100
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025, the patient underwent orif surgery for fibular fracture and tibiofibular fixation with the plate.After the tibiofibular fixation, the surgeon unpack and took a look at the tibia screwdriver seemed the connecting part where the tibia screw was attached looked a little bent, so the surgeon had them manually push it in and straighten it.The sales rep asked them to insert it as it was, and when the tibial screw was buried in the correct position, the sales rep asked the surgeon to untie the suture thread and remove the driver attachment.It came out easily, but at the same time, the silver and gold tubes inside had come out.The surgeon and the sales rep judged the procedure to be difficult after that, so the surgeon had them remove the tibial screw and tried to assemble it with each tube, but it didn't work, so the surgeon used a different product and the surgery was completed successfully within 30mins of delay.Other than the patient's good bone quality, the surgeon didn't seem to have handled it particularly roughly, so it seemed like there was some kind of internal loosening, but the surgeon said there was a spare so it wasn't a problem.
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: h6 component codes: most relevant component code is g07002 (appropriate term/code not available) to capture no findings available due to no product returned.H3, h6: product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.Device history lot: part: fgs-1100.Synthes lot # 23e016.Supplier lot # 23e016.Release to warehouse date: 01 nov 2023.Supplier: (b)(4).No ncr's generated during production.Device history review: review of the device history record(s) showed that there were no issues during the manufacture of this product, and any sub-components, which would contribute to this complaint condition.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: FIBULINK® SYNDESMOSIS REPAIR KIT/ TI
• Common Device Name: WASHER, BOLT NUT
• Manufacturer (Section D): SYNTHES GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: elba bello ; 1302 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 22609541
• Report Number: 8030965-2025-07511
• Device Sequence Number: 9603735
• Product Code: HTN
• UDI-Device Identifier: 00863176000317
• UDI-Public: (01)00863176000317(10)23E016
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K162805
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

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: FGS-1100
• Device Lot Number: 23E016
• 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: 07/09/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2023
• 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