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	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2021
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 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 excessive force being applied during use.
Event or Problem Description
On 12/14/2021, it was reported by a distributor via e-mail that a ar-2324slm swivelock is not working.This occurred on (b)(6) 2021 during a procedure when the surgeon inserted the anchor it would not go down after impacting and rolling the handle.No additional information.Additional information requested.Additional information provided on 12/15/2021 : the procedure being performed was a rotator cuff repair, and the case was completed using a non-arthrex device.

• 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: 19248418
• Report Number: 1220246-2024-02815
• Device Sequence Number: 6529906
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/06/2024

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: 08/31/2026
• Device Model Number: TITANIUM SWIVELOCK, 4.75X19.1MM
• Device Catalogue Number: AR-2324SLM
• Device Lot Number: 14173548
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2021
• Initial Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown