MAUDE Adverse Event Report: ARTHREX, INC. 4.75MM BC KNOTLESS SWIVELOCK W/ TAPE; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	4.75MM BC KNOTLESS SWIVELOCK W/ TAPE
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On 2/6/2023, it was reported by a sales representative via email that an ar-2324kbcctt biocomposite knotless swivelock eyelet broke off while tensioning.The rest of the anchor, screw and sutures remained in the patient.
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.
Additional Manufacturer Narrative
Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to misaligned insertion and/or prying/leveraging during use.
Event or Problem Description
Additional information received on 2/13/2023: this was discovered during an rcr procedure on (b)(6) 2023.While tensioning the knotless mechanism, the anchor broke off.An open cutter was used to cut the sutures that were passed through the eyelet.A king fisher was then used to grab the eyelet and the attached suture to remove from the joint the interlocked part of the knotless mechanism suture came out with it.Since the main part of the eyelet and screw stayed in place, the tigertape was kept in.

• Brand Name: 4.75MM BC KNOTLESS SWIVELOCK W/ TAPE
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• 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: vik bajnath ; 8009337001
• MDR Report Key: 16444312
• Report Number: 1220246-2023-06344
• Device Sequence Number: 17525515
• Product Code: MAI
• UDI-Device Identifier: 10888867351131
• UDI-Public: 10888867351131
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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,Followup
• Report Date (Section B): 09/03/2024

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: 4.75MM BC KNOTLESS SWIVELOCK W/ TAPE
• Device Catalogue Number: AR-2324KBCCTT
• Device Lot Number: 15023486
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2023
• Supplement Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 02/27/2023
• Supplement Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown