MAUDE Adverse Event Report: ARTHREX, INC. DX SWIVELOCK SL, 3.5X8.5MM W/FORK EYELET; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number	DX SWIVELOCK SL, 3.5X8.5MM W/FORK EYELET
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2021
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the fork of the device ar-8978p-1 (lot 11857988) broke during implantation.According to the surgeon no harm for patient, operator or third party occurred.The surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.Update on 13-sep-2021: it was confirmed that the ar-8978p-1 device was used first and when it broke, the ar-1530bc device was inserted into the same bone tunnel, which also broke.All fragments of the ar-8978p-1 were retrieved from the patient.
Additional Manufacturer Narrative
The complaint cannot be confirmed.One unpackaged ar-8978p-1 swivelock drive assembly was received for investigation.Visual inspection identified that neither the forked eyelet nor the swivelock screw were returned for analysis.The threaded tip at the distal end of the returned swivelock drive assembly was assessed under magnification using micro-vu id: 654 for any breakage, and the component was found to meet design specifications.Material residue was noticed, at the first thread.Without the return of the forked eyelet and swivelock screw, the alleged breakage noted in the event description cannot be verified.No problem was observed with the returned assembly.

• Brand Name: DX SWIVELOCK SL, 3.5X8.5MM W/FORK EYELET
• Common Device Name: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12540281
• Report Number: 1220246-2021-03711
• Device Sequence Number: 3585818
• Product Code: MBI
• UDI-Device Identifier: 00888867287105
• UDI-Public: 00888867287105
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K150648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2021

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: DX SWIVELOCK SL, 3.5X8.5MM W/FORK EYELET
• Device Catalogue Number: AR-8978P-1
• Device Lot Number: 11857988
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/10/2021
• Supplement Date Received by Manufacturer: 09/10/2021
• Initial Report FDA Received Date: 09/28/2021
• Supplement Report FDA Received Date: 10/22/2021
• Patient Sequence Number: 1