MAUDE Adverse Event Report: ARTHREX, INC. DBL LOADED 4.75MM BIO-COMP SWVLK; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	DBL LOADED 4.75MM BIO-COMP SWVLK
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 2/7/2022, it was reported by a sales representative via email that an ar-2324bcc-2 swivelock anchor frayed and produced debris when it was inserted about half way down the bone.Surgeon used an ar-1927pbs punch to prep the bone socket for the anchor and loaded an ar-7501 suturetape into the eyelet of the anchor.When surgeon had inserted the anchor, about half way down, the anchor started peeling like a pencil in a pencil sharpener.Surgeon was able to twist out and remove both the anchor and debris.A second bone hole was created using an ar-2324ptb tap and an ar-2324bcc-2 swivelock anchor was inserted to complete case.No further issues has been reported.This was discovered during a supraspinatus tendon repair.
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.

• Brand Name: DBL LOADED 4.75MM BIO-COMP SWVLK
• 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: 13619234
• Report Number: 1220246-2022-04504
• Device Sequence Number: 13987091
• Product Code: MAI
• UDI-Device Identifier: 00888867097995
• UDI-Public: 00888867097995
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 02/28/2022

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: 06/30/2025
• Device Model Number: DBL LOADED 4.75MM BIO-COMP SWVLK
• Device Catalogue Number: AR-2324BCC-2
• Device Lot Number: 13769120
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2022
• Initial Report FDA Received Date: 02/28/2022
• Date Device Manufactured: 07/21/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown