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

Catalog Number	FGS-1100
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2025
Type of Reportable Event	Malfunction
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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2025, the patient underwent ankle orif surgery for ankle fractures with fibulink repair kit.The surgeon inserted a tibial screw on the tibial side, removed the driver and attached a tensioning cap, then grasped the silver guide tube with a needle holder and pulled it outward, but the permacord did not deploy.The surgeon tried to pull on the silver guide tube with pliers and both the silver and gold guide tubes came out.The surgeon again attempted to insert the silver guide tube through the tensioning cap but was unable to do so and after several attempts the tip of the silver guide tube became bent.Therefore, the fibula-link and tensioning cap could not be fitted.In the end, since no removal instrument was prepared, the surgeon removed the tensioning cap, gave up on the fibulink with the fibula-link remaining in the tibial screw on the tibial side, and completed the surgery by inserting a cortex screw through the distal screw hole.The surgery was completed successfully within 30 minutes surgical delay.No further information is available.
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: device history review, part # fgs-1100, synthes lot # 24e010, supplier lot # 24e010, release to warehouse date: 05 jun 2024, supplier: (b)(4).No ncr's generated during production.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 medwatch, a follow-up medwatch 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 wrights lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 22650196
• Report Number: 8030965-2025-07712
• Device Sequence Number: 12967538
• Product Code: HTN
• UDI-Device Identifier: 00863176000317
• UDI-Public: (01)00863176000317(17)270601(10)24E010
• 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: Physician
• 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: 24E010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2025
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/05/2024
• 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
• Patient Sex: Unknown