MAUDE Adverse Event Report: ARTHREX, INC. PEEK, 3.9MM KNOTLESS CORKSCREW W/ #5 MTS; BIO SOFT TISSUE FIXATN FASTNR

Model Number	PEEK, 3.9MM KNOTLESS CORKSCREW W/ #5 MTS
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 2/5/2024, it was reported by a sales representative via email that an ar-1941psv peek knotless corkscrew anchor broke when shuttling the repair stitch through the anchor body.The surgeon was unable to tension down fully.The anchor was removed, and the case was completed using another ar-1941psv peek knotless corkscrew anchor.This was discovered during an unspecified procedure on (b)(6) 2024.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Based on the information provided, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional information from the field, arthrex concluded that the most likely cause.The most likely cause of the reported failure is user error, specifically misalignment of the insertion.Directions for use (dfu) dfu-0087-eor3_fmt_en.Corkscrew, pushlock, and swivelock suture anchors.G.Precautions.8.Self-punching pushlock and swivelock suture anchors only: ensure that the angle of anchor insertion is perpendicular to the bone.The complaint allegation was not confirmed.The device was not received for evaluation, and no evidence of the failure was provided.

• Brand Name: PEEK, 3.9MM KNOTLESS CORKSCREW W/ #5 MTS
• 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: 18761655
• Report Number: 1220246-2024-01073
• Device Sequence Number: 20782379
• Product Code: MAI
• UDI-Device Identifier: 00888867344921
• UDI-Public: 00888867344921
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K193157
• 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,Followup
• Report Date (Section B): 06/03/2025

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: PEEK, 3.9MM KNOTLESS CORKSCREW W/ #5 MTS
• Device Catalogue Number: AR-1941PSV
• Device Lot Number: 15148060
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 02/22/2024
• Supplement Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2023
• 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