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 Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2022

Event Type  Injury  

Event Description

Device report from synthes reports an event in the usa as follows: it was reported that on an unknown date, fibulink® syndesmosis repair kit/ss was broken.This complaint involves one (1) device fibulink® syndesmosis repair kit/ss.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).Additional narrative: complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).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.The photo was returned to depuy synthes for evaluation.The depuy synthes team conducted a visual inspection of the returned device from photos.Visual analysis of the photos revealed that the fibulink® syndesmosis repair kit/ss was broken.X-ray evidence "(b)(4) x-rays (2)" shows the fibula link being migrated from the fibula tensioning cap.In evidence "(b)(4) x-rays (1)" the fibula link appears to have broken from the left end, fragment remained inside the fibula tensioning cap.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 the 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.

• 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: 14914150
• MDR Text Key: 295226466
• Report Number: 1719045-2022-00021
• Device Sequence Number: 1
• Product Code: HTN
• UDI-Device Identifier: 00863176000300
• UDI-Public: (01)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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2022
• 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-US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention