MAUDE Adverse Event Report: ARTHREX, INC. 4.75MM PEEK KNOTLESS SWIVELOCK W/ TAPE; BIO SOFT TISSUE FIXATN FASTNR

Model Number	4.75MM PEEK KNOTLESS SWIVELOCK W/ TAPE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by a sales representative via email that an ar-2324kpctt peek knotless swivelock eyelet attached to the knotless mechanism, pulled out through the cannulation of the screw.The piece was found floating in the joint and was able to be retrieved in full.No broken pieces remained in the patient.The anchor body itself stayed in place.No known patient harm, no delay, and no backup device needed.The case was completed without doing the knotless construct.Although, before the eyelet had broken off, the surgeon had already decided not to do the knotless construct.This was discovered during a routine rcr procedure.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information.The complaint allegation was confirmed.One unpackaged ar-2324kpctt peek knotless swivelock® suture anchor, 4.75 x 19.1 mm, ve5 with serial/batch number (b)(6) was received for evaluation.The only received component for evaluation was a piece of the eyelet attached to blue suture.Upon visual inspection, it was revealed that the eyelet was broken/damaged, with only a piece left on the suture.The suture attached to the eyelet was frayed, with some filaments protruding.Functional testing was not performed due to the received part is damaged.The method of bone preparation employed during the procedure and the bone quality encountered were not provided.The most likely cause of the reported failure is a user error, such as misaligned insertion, prying/leveraging, and/or applying excessive force on the device during use.

• Brand Name: 4.75MM PEEK KNOTLESS SWIVELOCK W/ TAPE
• 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: jared engle ; 8009337001
• MDR Report Key: 20215301
• Report Number: 1220246-2024-07609
• Device Sequence Number: 20797888
• Product Code: MAI
• UDI-Device Identifier: 10888867351155
• UDI-Public: 10888867351155
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K193503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2025

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: 4.75MM PEEK KNOTLESS SWIVELOCK W/ TAPE
• Device Catalogue Number: AR-2324KPCTT
• Device Lot Number: 15248959
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2024
• Supplement Date Received by Manufacturer: 01/03/2025
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2024
• 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