MAUDE Adverse Event Report: ARTHREX, INC. 5.5MM BC KNOTLESS SWIVELOCK; BIO SOFT TISSUE FIXATN FASTNR

Model Number	5.5MM BC KNOTLESS SWIVELOCK
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2022
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.Complaint not confirmed.Upon visual inspection it was noted that the screw was stuck at the end of the driver.It was also noted that the suture anchor had been removed from the shaft of the driver.Upon functional testing it was found that the screw could be removed from the inserter using the sleeve of the inserter.Device functions as required.No problem found.
Event or Problem Description
On 5/12/2022, it was reported by an arthrex employee via email that an ar-2323kbcc biocomposite knotless swivelock was spinning and would not advance, the screw was stuck on the inserter shaft and did not seat on the bone.Surgeon used a new product and case was completed without further issues.This was discovered during a procedure on (b)(6) 2022.Additional information received on 5/13/2022: this was discovered during an rcr proceudre and it has been confirm that the screw did not break inside the patient, only got stuck to the inserter.Case was completed using another ar-2323kbcc biocomposite knotless swivelock.

• Brand Name: 5.5MM BC KNOTLESS SWIVELOCK
• 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: 19298415
• Report Number: 1220246-2024-03183
• Device Sequence Number: 14956544
• Product Code: MAI
• UDI-Device Identifier: 10888867351353
• UDI-Public: 10888867351353
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K193503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/13/2024

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: 09/30/2025
• Device Model Number: 5.5MM BC KNOTLESS SWIVELOCK
• Device Catalogue Number: AR-2323KBCC
• Device Lot Number: 14244937
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2022
• Initial Report FDA Received Date: 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2021
• 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