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

Catalog Number	FGS-1100
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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.H11 additional narrative: 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
This pc is related to (b)(4) which reports an infection that was confirmed after primary surgery and removal surgery was performed.This pc reports the screw could not be removed in the removal surgery on (b)(6) 2025.It was reported that on (b)(6) 2025, the patient underwent primary surgery for open ankle fracture-dislocation with fibulink repair kit.On (b)(6) 2025, the sales rep was informed by the surgeon that the fibulink repair kit was scheduled to be removed due to signs of infection in the wound.On (b)(6) 2025, the surgery was performed to remove the fibulink repair kit along with a distal fibula plate from another manufacturer.During surgery, the surgeon used a fibulink removal kit to attempt removal, but the tibial screw would not turn.Therefore, the surgeon gave up, considering the risk of deformation of the tip of the tibial screwdriver or the tibial screw head.After removing the fibulink, the surgeon used a tibial screw remover on the tibial screw, but the tibial screw still did not rotate.Even when extraction screws (309.510/309.520) were used, the tibial screw did not rotate.Upon checking the image, damage to the tibial screw head was confirmed.The surgeon determined that the tibial screw would be difficult to remove, and the surgery was completed with it left in place.The surgeon stated that he recognized the cause as being difficult to remove due to screw breakage during removal, and that he was not aware of any product defects but noted that there was a risk of this occurring in the future due to product characteristics.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: added: h4.H6: the product was not returned to j&j medtech orthopaedics, however photos were provided for review.The x-ray investigation revealed found the screw implant was broken from the shaft.The reported allegation of embedded can be confirmed.The observed condition of the device was consistent with a random component failure that may have been caused by exposure to unintended forces.As the device was not returned, an as-received condition could not be assessed, and a dimensional inspection and document/specification review were not completed.The overall complaint was confirmed as the observed condition of the fibulink syndesmosis repair kit ti would have contributed to the complained device issue.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety 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 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 wright lane east; west chester, PA 19380 ; 9083863534
• MDR Report Key: 22819906
• Report Number: 8030965-2025-08467
• Device Sequence Number: 8756531
• Product Code: HTN
• UDI-Device Identifier: 00863176000317
• UDI-Public: (01)00863176000317(17)261101(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
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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?: Yes
• 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): Initial
• Initial Date Received by Manufacturer: 07/31/2025
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 27 YR
• Patient Sex: Male