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

Catalog Number	FGS-1000
Medical Device Problem Codes	Break (1069); Difficult to Advance (2920)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/05/2023
Type of Reportable Event	Malfunction
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.H10 additional narrative: a1: e01001142719.D9: complainant part is not expected to be returned for manufacturer review/investigation.H3, h6: the investigation could not be completed; no conclusion could be drawn, as no product was received.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.Device was used for treatment, not diagnosis.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), 2023 during open reduction internal fixation (orif) ankle procedure, the surgeon implanted a fibulink to treat ankle fracture.As he turned the black knob to engage the fibulink and tighten the device, it was noticed that the torque limiter was never engaged.The black knob remained able to turn even after the link was fully deployed and confirmed under x-ray.The surgeon felt the syndesmosis was not stable and wanted to remove the fibulink and place a syndesmosis screw.He pulled the gold and silver wires from the inserter and the link and button came out.The sales rep left the room to get a removal kit to remove the tibial screw and after he returned, a 3.5mm cortex screw had already been placed to stabilize the syndesmosis.The surgeon decided not to remove the fibulink screw from the tibia.The case was then completed.There was no surgical delay.The procedure was completed successfully.Fragments were generated.No attempt was made to remove the screw.This report is for one (1) fibulink® syndesmosis repair kit/ss.This is report 1 of 1 for complaint (b)(4).
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.H4, h6 part # fgs-1000, synthes lot # 22e022 , supplier lot # 22e022 , release to warehouse date # 24 jan 2023 , supplier # (b)(4).No non conformance reports were generated during production.Device was used for treatment, not diagnosis.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/SS
• Common Device Name: WASHER, BOLT NUT
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer Contact: kate karberg ; 1302 wrights lane east; west chester, PA 19380 ; 8472871282
• MDR Report Key: 17789294
• Report Number: 8030965-2023-11937
• Device Sequence Number: 7750263
• Product Code: HTN
• UDI-Device Identifier: 00863176000300
• UDI-Public: (01)00863176000300
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K162805
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: 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 Expiration Date: 11/01/2025
• Device Catalogue Number: FGS-1000
• Device Lot Number: 22E022
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2023
• Supplement Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 09/21/2023
• Supplement Report FDA Received Date: 10/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK - SCREWS: 3.5 MM CORTEX; UNK - SCREWS: SYNDESMOTIC SCREW
• Patient Age: 20 YR
• Patient Sex: Male