MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK RC, DOUBLOAD TAPE BL/W, BLK/W; NON-DEGRADABLE FIXATN FASTENER

Model Number	FIBERTAK RC, DOUBLOAD TAPE BL/W, BLK/W
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during biceps tenodesis surgery both anchors did not gripp.There was no harm or adverse event for patient, operator or third party reported.The surgery was finished successfully with a different part, swive lock.It was not necessary to switch the surgical technique or do a second surgery.No further information received.Update, 16-mar-2021 -sac received further information that another drill was not necessary.No further information received.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Complaint not confirmed.Visual evaluation showed the devices were received disassemble from the inserter shaft prior to received.No damaged was observed to the shaft or suture assembly.Review of device history record showed the device was assembled per specifications.The most likely causes are improper bone prep and/or misaligned insertion.

• Brand Name: FIBERTAK RC, DOUBLOAD TAPE BL/W, BLK/W
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 19558624
• Report Number: 1220246-2024-05926
• Device Sequence Number: 11964930
• Product Code: MBI
• UDI-Device Identifier: 00888867276901
• UDI-Public: 00888867276901
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K200341
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/18/2024

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 Expiration Date: 11/30/2025
• Device Model Number: FIBERTAK RC, DOUBLOAD TAPE BL/W, BLK/W
• Device Catalogue Number: AR-3632
• Device Lot Number: 12214664
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown