MAUDE Adverse Event Report: ARTHREX, INC. 4.75MM BC KNOTLESS SWIVELOCK; BIO SOFT TISSUE FIXATN FASTNR

Model Number	4.75MM BC KNOTLESS SWIVELOCK
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation; no pictures were provided.The most likely cause for the reported failure is user error.Per dfu-0087-11.G.Precautions.5.Pushlock and swivelock suture anchor only: insert the driver into the bone socket until the anchor body makes contact with the bone.Preview and adjust suture tension, if necessary.Tension will not increase during the final advancement of the anchor body.
Event or Problem Description
It was reported that a biocomposite knotless swivelock, ar-2324kbcc, was being used in a procedure.When putting the anchor into the punched bone tunnel, the two fibertapes that were in the eyelet, ripped through the edge of the peek eyelet.The surgeon replaced with an ar-2324bcc, with lot# 11772467.No fragments were left in the patient from the broken eyelet piece and the surgery was completed successfully with no adverse effect to the patient.

• Brand Name: 4.75MM BC KNOTLESS SWIVELOCK
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: emily shafer ; 8009337001
• MDR Report Key: 18300034
• Report Number: 1220246-2023-09332
• Device Sequence Number: 17932256
• Product Code: MAI
• UDI-Device Identifier: 10888867351285
• UDI-Public: 10888867351285
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K193503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/11/2023

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: 04/30/2024
• Device Model Number: 4.75MM BC KNOTLESS SWIVELOCK
• Device Catalogue Number: AR-2324KBCC
• Device Lot Number: 10984717
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2021
• Initial Report FDA Received Date: 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/18/2020
• 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