MAUDE Adverse Event Report: ARTHREX, INC. SWIVELOCK, SP BC 5.5MM; NON-DEGRADABLE FIXATN FASTENER

Model Number	SWIVELOCK, SP BC 5.5MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 02/28/2024, it was reported by a sales representative via email that the eyelet from an ar-2323bcsp self punching biocomposite swivelock broke.This was discovered during an rcr procedure on (b)(6) 2024.No further information was provided.Additional information was requested.Additional information was provided on 03/01/2024, where the sales representative reported the device did break inside the patient, and all fragments were retrieved.The case was completed using an ar-2323bcsp swivelock.The patient had a hard bone that was not prepped with an instrument.
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.
Additional Manufacturer Narrative
This report is being submitted to provide additional information in d9, h3, h6: health effect - clinical code, health effect - impact code, type of investigation, investigation findings, investigation conclusions, and h10 complaint is confirmed.Visual evaluation identified that the self punching peek eyelet swivelock had broken.Functional testing could not be conducted due to the damage to the eyelet.The customer reported hard bone quality.The most likely causes of the failure are improper bone prep, misaligned insertion, and prying/leveraging the device during insertion.

• Brand Name: SWIVELOCK, SP BC 5.5MM
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• 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: 18887963
• Report Number: 1220246-2024-01430
• Device Sequence Number: 7774114
• Product Code: MAI
• UDI-Device Identifier: 00888867384439
• UDI-Public: 00888867384439
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K222263
• 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,Followup
• Report Date (Section B): 06/26/2024

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: SWIVELOCK, SP BC 5.5MM
• Device Catalogue Number: AR-2323BCSP
• Device Lot Number: 15136846
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2024
• Supplement Date Received by Manufacturer: 06/02/2024
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2023
• 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