MAUDE Adverse Event Report: ARTHREX, INC. DBL LOADED 4.75MM BC SWVLK; SHOULDER PROSTHESIS, REVERSE CONFIGURATION

Model Number	DBL LOADED 4.75MM BC SWVLK
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/18/2021
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 during a shoulder arthroscopy with rotator cuff repair, the tip retention sutures on a quantity two ar-2324bct-2 ripped through the eyelet of the anchor before insertion into the bone, causing the anchor to be unusable and unable to be inserted.When viewing the failed anchor arthroscopically it appeared that the tip retention sutures had serrated at the apex of the suture that interfaces with the suture eyelet, causing the eyelet to detach from the inserter causing the anchor to fail.After two anchors malfunctioned, the surgeon used a ar-2324bcct and unloaded the fibertape to use for the subscap repair.

• Brand Name: DBL LOADED 4.75MM BC SWVLK
• Common Device Name: SHOULDER PROSTHESIS, REVERSE CONFIGURATION
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11946756
• Report Number: 1220246-2021-03213
• Device Sequence Number: 3235529
• Product Code: MAI
• UDI-Device Identifier: 00888867251236
• UDI-Public: 00888867251236
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 06/07/2021

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 Model Number: DBL LOADED 4.75MM BC SWVLK
• Device Catalogue Number: AR-2324BCT-2
• Device Lot Number: 12879159
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 06/07/2021
• Patient Sequence Number: 1