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

Model Number	FIBERTAK RC, TRIPLOAD TAPE BL/W, BLK/W W
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2021
Type of Reportable Event	Malfunction
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.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation.As no further investigation was able to be performed no change in harm was identified.This complaint will be included in trending per wi-000100100.
Event or Problem Description
On 9/8/2021 it was reported by a sales representative via email that an ar-3633 fibertak¿ rc suture anchor, triple loaded would not seat in the pre-drilled bone tunnel.This was discovered during a procedure on (b)(6) 2021.No patient affected.Device will not be returned as it was discarded by facility.Additional info received 9/15/2021 surgeon completed rotator cuff massive tear repair by using another ar-3633 anchor.

• Brand Name: FIBERTAK RC, TRIPLOAD TAPE BL/W, BLK/W 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: 19483214
• Report Number: 1220246-2024-05173
• Device Sequence Number: 15461228
• Product Code: MBI
• UDI-Device Identifier: 00888867276925
• UDI-Public: 00888867276925
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K151230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/07/2024

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: 03/31/2026
• Device Model Number: FIBERTAK RC, TRIPLOAD TAPE BL/W, BLK/W W
• Device Catalogue Number: AR-3633
• Device Lot Number: 13168923
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown