MAUDE Adverse Event Report: AKROS MEDICAL, INC FIBULINK REMOVAL KIT; WASHER, BOLT NUT

Model Number	FGS-1300
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional narrative: complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.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 (b)(6) 2021, the fibulink screw was inserted into the tibia and then once the silver tube was filled the other way the link did not engage into the cap most likely the extended cap was needed.Surgeon pulled on the silver tube again to try to engage it and the tube released.Therefore, releasing the entire implant before the procedure was able to be completed and then the screwdriver would not engage into the screw to be able to remove it, so a removal kit had to be open and used to removed the implant.Procedure was successfully completed with a twenty(20) minutes delay.This report is for one (1) fibulink® removal kit.This is report 2 of 2 for complaint (b)(4).

• Brand Name: FIBULINK REMOVAL KIT
• Common Device Name: WASHER, BOLT NUT
• Manufacturer (Section D): AKROS MEDICAL, INC; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 12028939
• Report Number: 3013401747-2021-00041
• Device Sequence Number: 4269870
• Product Code: HTN
• UDI-Device Identifier: 00863176000324
• UDI-Public: (01)00863176000324
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: PRE-AMEND
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/26/2021

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
• Operator of Device: Health Professional
• Device Model Number: FGS-1300
• Device Catalogue Number: FGS-1300
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/26/2021
• Initial Report FDA Received Date: 06/18/2021
• Patient Sequence Number: 1
• Patient Age: 18 YR