MAUDE Adverse Event Report: ARTHREX, INC. SP FBRTAK RC TGRTPE WH/BLK & STTPE WH/BL; NON-DEGRADABLE FIXATION FASTENER

Model Number	SP FBRTAK RC TGRTPE WH/BLK & STTPE WH/BL
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 5/31/2022, it was reported by a sales representative via email that an ar-3652tsp fibertak rc suture anchor, blue, and an ar-3652sp fibertak rc suture anchor, white/black, failed during a procedure.Additional information requested.
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 excessive force being applied during use.

• Brand Name: SP FBRTAK RC TGRTPE WH/BLK & STTPE WH/BL
• Common Device Name: NON-DEGRADABLE FIXATION 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: 19194095
• Report Number: 1220246-2024-02477
• Device Sequence Number: 20767119
• Product Code: MBI
• UDI-Device Identifier: 10888867362908
• UDI-Public: 10888867362908
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K232973
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/26/2024

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 Model Number: SP FBRTAK RC TGRTPE WH/BLK & STTPE WH/BL
• Device Catalogue Number: AR-3652SP
• Device Lot Number: 14953855
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/26/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown