MAUDE Adverse Event Report: ARTHREX, INC. 4.75MM PEEK KNOTLESS SWIVELOCK; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	4.75MM PEEK KNOTLESS SWIVELOCK
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On 03/10/2022, it was reported by a sales representative via email that an ar-2324kpslc peek knotless swivelock seems to be fraying and cutting an ar-7535 fiberlink suture tape suture when the suture comes in contact with the metal driver during tensioning.This was discovered during a revision subpec tenodesis procedure on (b)(6) 2022.This issue has caused the bicep to retract and causing patient pain.The original procedure was a biceps loop n tak.Surgeon was able to correct issue with a 2.6 knotless fibertak subpc onlay.
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
The complaint is unable to be confirmed through the customer provided photos and without receipt of the device for physical evaluation and testing.No change in harm was identified.

• Brand Name: 4.75MM PEEK KNOTLESS SWIVELOCK
• 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: 13928473
• Report Number: 1220246-2022-04657
• Device Sequence Number: 6251220
• Product Code: MAI
• UDI-Device Identifier: 10888867351339
• UDI-Public: 10888867351339
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 4.75MM PEEK KNOTLESS SWIVELOCK
• Device Catalogue Number: AR-2324KPSLC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2022
• Supplement Date Received by Manufacturer: 03/10/2022
• Initial Report FDA Received Date: 03/28/2022
• Supplement Report FDA Received Date: 04/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown