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

Catalog Number FGS-1000

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/21/2022

Event Type  malfunction  

Event Description

It was reported on (b)(6) 2022, that the suture bridge between the tibial screw and fibula link broke.The surgery was not delayed because of it and no adverse events occurred.The procedure was successfully completed.Concomitant device: unknown screws (product code: unk, lot number: unk, quantity: unk).This report is for one (1) fibulink® syndesmosis repair kit/ss.This is report 1 of 1 for complaint (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.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.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.

• 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 ; 1101 synthes avenue; monument, CO 80132 ; 3035526892
• MDR Report Key: 15057209
• MDR Text Key: 304348440
• Report Number: 1719045-2022-00022
• Device Sequence Number: 1
• Product Code: HTN
• UDI-Device Identifier: 07612334226358
• UDI-Public: (01)07612334226358
• 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: 07/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FGS-1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2022
• 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: UNKNOWN SCREWS
• Patient Sex: Female