MAUDE Adverse Event Report: ARTHREX, INC. DBL LOADED 5.5MM BC SWVLK; BIO SOFT TISSUE FIXATN FASTNR

Model Number	DBL LOADED 5.5MM BC SWVLK
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On 12/22/2021, it was reported by a facility representative via email that an ar-2323bct-2 swivelock failed when surgeon removed inserter handle and all the sutures came out of the peek anchor.This was discovered during a procedure on the (b)(6) 2021.After additional information received on 12/22/2021, facility representative has confirmed that this occurred during a rcr and all the sutures that came off the anchor and the implanted anchor, were removed from inside the patient.Surgeon used the same bone socket previously created to insert a new swivelock anchor from the same lot number as the failed one.Case was completed successfully without further issues.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to user error of the device due to user-applied mechanical forces.

• Brand Name: DBL LOADED 5.5MM BC SWVLK
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: jared engle ; 8009337001
• MDR Report Key: 19203520
• Report Number: 1220246-2024-02565
• Device Sequence Number: 12774747
• Product Code: MAI
• UDI-Device Identifier: 00888867251069
• UDI-Public: 00888867251069
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/29/2024

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 Expiration Date: 05/31/2023
• Device Model Number: DBL LOADED 5.5MM BC SWVLK
• Device Catalogue Number: AR-2323BCT-2
• Device Lot Number: 13590005
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2021
• Initial Report FDA Received Date: 04/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown