MAUDE Adverse Event Report: AKROS MEDICAL, INC FIBULINK SYNDESMOSIS REPAIR KIT/SS; WASHER, BOLT NUT

Model Number FGS-1000

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 12/09/2020

Event Type  malfunction  

Manufacturer Narrative

Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is jnj representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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 Description

It was reported that during an unknown procedure on (b)(6) 2020, the fibulink syndesmosis repair kit/ss was partly broken.The first half of the device came off intra operatively.The broken piece was successfully retrieved.There was no patient consequence reported.It is unknown if there was a surgical delay.The surgical outcome was unknown.This complaint involves one (1) device.This report is for (1) fibulink® syndesmosis repair kit/ss.This report is 1 of 1 for (b)(4).

• Brand Name: FIBULINK SYNDESMOSIS REPAIR KIT/SS
• Type of Device: WASHER, BOLT NUT
• Manufacturer (Section D): AKROS MEDICAL, INC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• Manufacturer Contact: kara ditty-bovard ; 1302 wright lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 11135169
• MDR Text Key: 241679096
• Report Number: 3013401747-2021-00001
• Device Sequence Number: 1
• Product Code: HTN
• UDI-Device Identifier: 00863176000300
• UDI-Public: 00863176000300
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2021
• Is this an Adverse Event Report?: No
• 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: 12/09/2020
• 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