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

Catalog Number FGS-1000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Non-union Bone Fracture (2369); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

It was reported that on unknown date, the patient underwent an external fixation with orif with single screw followed by syndesmotic screw removal and fibulink implantation.The initial erif and orif was 1 hour 15 minutes while the fibulink procedure is 15 minutes.There was a post operative infection with fractured syndesmotic screw failure due to patient fall.Fibulink was implanted with no issues.Patient has non union of the segmental fibula fracture noted.It was stated that the complications were unrelated to the device.The wound is healed in a duration of 4 months.No further information is available.This report is for one (1) fibulink® syndesmosis repair kit/ss.This is report 3 of 3 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: christopher hammond ; eimattstrasse 3; oberdorf 4436 ; SZ 4436 ; 6107195721
• MDR Report Key: 11316407
• MDR Text Key: 231577494
• Report Number: 3013401747-2021-00010
• Device Sequence Number: 1
• Product Code: HTN
• 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: Physician
• Type of Report: Initial
• Report Date: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 01/22/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR