MAUDE Adverse Event Report: ARTHREX, INC. TITANIUM SWIVELOCK, 4.75X19.1MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	TITANIUM SWIVELOCK, 4.75X19.1MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2022
Type of Reportable Event	Malfunction
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 most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation, prying/leveraging the device and/or excessive force being used during insertion of the implant.
Event or Problem Description
It was reported on (b)(6) 2022 by a facility representative via email that an ar-2324slm suture anchor suture broke.This was discovered during case with no patient harm.Per facility: "the sutures are betrayed gently, and at the moment of fixing the anchors, one of the sutures is cut (it breaks)".

• Brand Name: TITANIUM SWIVELOCK, 4.75X19.1MM
• 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: 19179833
• Report Number: 1220246-2024-02356
• Device Sequence Number: 7431026
• Product Code: MAI
• UDI-Device Identifier: 00888867026940
• UDI-Public: 00888867026940
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K151342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/25/2024

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 Model Number: TITANIUM SWIVELOCK, 4.75X19.1MM
• Device Catalogue Number: AR-2324SLM
• Device Lot Number: 14464090
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2022
• Initial Report FDA Received Date: 04/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown