MAUDE Adverse Event Report: ARTHREX, INC. DBL LOADED 4.75MM BC SWVLK; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number	DBL LOADED 4.75MM BC SWVLK
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/29/2021
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
It was reported that a double loaded swivelock arrived with shredded sutures, appearing like they had de-threaded right where the tigertail portion of the suture met the solid colored portion of the suture.This was noticed when trying to slide the sutures back and forth after implantation during a rotator cuff repair.The case was completed by leaving the anchor implanted, and used a new one by punching in the same hole and was able to remove small pieces and implant another anchor in the same location.
Additional Manufacturer Narrative
This complaint is confirmed.The device was not returned for investigation, however pictures were provided by the customer.Review of the pictures show four (4) sutures with the ends frayed on each suture.The sutures are loose and not attached to the inserter or any anchors in the picture.This batch number is within scope of ncr-16305 which was related to sutures fraying during use due to a manufacturing defect.Please refer to ncr-16305 for further details.

• Brand Name: DBL LOADED 4.75MM BC SWVLK
• Common Device Name: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11998688
• Report Number: 1220246-2021-03283
• Device Sequence Number: 19887339
• Product Code: MAI
• UDI-Device Identifier: 00888867251236
• UDI-Public: 00888867251236
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• 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): 10/22/2021

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: 12/31/2022
• Device Model Number: DBL LOADED 4.75MM BC SWVLK
• Device Catalogue Number: IMPLANTABLE
• Device Lot Number: 12439668
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/29/2021
• Supplement Date Received by Manufacturer: 05/29/2021
• Initial Report FDA Received Date: 06/15/2021
• Supplement Report FDA Received Date: 10/22/2021
• Patient Sequence Number: 1