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

Catalog Number	FGS-1100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary this pc is related to (b)(4) which reports the screw could not be removed in the removal surgery on (b)(6) 2025.This pc reports an infection that was confirmed after primary surgery and removal surgery was performed.It was reported that on (b)(6) 2025, the patient underwent primary surgery for open ankle fracture-dislocation with fibulink repair kit.The surgery was completed successfully without any surgical delay.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.No further information is available.The product was not returned to j&j medtech orthopedics, however photos were provided for review.The x-ray investigation revealed nothing indicative of a device nonconformance.It can be observed the screw implants with no defect.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 not confirmed as the observed condition of the fibulink syndesmosis repair kit ti would have not contributed to the reported adverse event.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 orthopedics 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 lo 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 batch null device history 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.
Event or Problem Description
This pc is related to (b)(4) which reports the screw could not be removed in the removal surgery on (b)(6) 2025.This pc reports an infection that was confirmed after primary surgery and removal surgery was performed.It was reported that on (b)(6) 2025, the patient underwent primary surgery for open ankle fracture-dislocation with fibulink repair kit.The surgery was completed successfully without any surgical delay.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.No further information is available.

• 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: 22819905
• Report Number: 8030965-2025-08466
• Device Sequence Number: 12197199
• 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

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: 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
• Initial Report FDA Received Date: 08/15/2025
• 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