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

Model Number	FGS-1100
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that on unknown date, the patient underwent an open reduction internal fixation (orif) of the fibula and medial malleolus with a hook plate and syndesmotic repair with the fibulink.There was difficulty engaging the fibulink device into the tibia component.A larger hat was used and engaged right away.Postoperatively, the patient had no pain to the ankle but mild pain along the peroneal tendons.The patient was doing well, walking in regular shoes and back to all activities with minimal swelling.The wound healed in a duration of six (6) months.This report is for one (1) fibulink® syndesmosis repair kit/ti.This is report 1 of 3 for (b)(4).

• Brand Name: FIBULINK SYNDESMOSIS REPAIR KIT/TI
• Common Device Name: WASHER, BOLT NUT
• Manufacturer (Section D): AKROS MEDICAL, INC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 11313338
• Report Number: 3013401747-2021-00008
• Device Sequence Number: 11690283
• Product Code: HTN
• UDI-Device Identifier: 00863176000317
• UDI-Public: 00863176000317
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173550
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: FGS-1100
• Device Catalogue Number: FGS-1100
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 02/11/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR