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

Model Number FGS-1000

Device Problem Break (1069)

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

Event Date 09/28/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device available for evaluation: complainant part is not expected to be returned for manufacturer review/ investigation.Device evaluated by mfr: the investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.The product was not returned.Based on the information available, it has been determined that no corrective and 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 history lot : part/lot combination is not valid, therefore the dhr could not be completed.If the device is returned or the lot number is confirmed the dhr will be revisited.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 on (b)(6) 2021, the patient underwent for a surgery.During the procedure, the surgeon wants to implant the fibulink k wire and in the dawn while was attempting to do over the k wire.But doctor noticed that bit was broken.Fragments are removed without additional intervention.The surgery was completed successfully with a 5-minute surgical delay.Patient outcome is unknown.This complaint involves one (1) device.This report is for one (1) fibulink® syndesmosis repair kit/ss.This is report 1 of 1 for complaint (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: 12703351
• MDR Text Key: 278549961
• Report Number: 3013401747-2021-00061
• 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: K173550
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/28/2021

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
• Device Operator: Health Professional
• Device Model Number: FGS-1000
• Device Catalogue Number: FGS-1000
• Device Lot Number: 21E016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2021
• Initial Date FDA Received: 10/27/2021
• 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 Age: 40 YR