MAUDE Adverse Event Report: MONUMENT DEPUY SYNTHES PRODUCTS INC FIBULINK® SYNDESMOSIS REPAIR KIT/SS; WASHER, BOLT NUT

Model Number FGS-1000

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Date 07/07/2022

Event Type  Injury  

Event Description

It was reported that on an unknown date a fibulink was implanted into a patient along with a syndesmotic screw.The screw as well as the suture in fibulink broke post-operatively.It was reported that no revision surgery is necessary.This report is for the fibulink implant.This is report 2 of 2 for (b)(4).

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.A photo investigation was completed: visual analysis of the photo revealed that the fibulink® syndesmosis repair kit/ss was found broken, the broken fragment was visible in x-ray provided.No other problems were reported.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.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.The overall complaint was confirmed for fibulink® syndesmosis repair kit/ss.There is no indication that a design or manufacturing issue has caused the complaint condition and hence the root cause cannot be determined.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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
• Type of Device: WASHER, BOLT NUT
• Manufacturer (Section D): MONUMENT DEPUY SYNTHES PRODUCTS INC; 1101 synthes avenue; monument CO 80132
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 15163964
• MDR Text Key: 297235243
• Report Number: 1719045-2022-00025
• Device Sequence Number: 1
• Product Code: HTN
• UDI-Device Identifier: 00863176000300
• UDI-Public: 00863176000300
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162805
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FGS-1000
• Device Catalogue Number: FGS-1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNK - SCREWS: TRAUMA
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR
• Patient Weight: 159 KG