MAUDE Adverse Event Report: ARTHREX, INC. DX SWIVELOCK, 3.5 X 13.5 MM; NON-DEGRADABLE FIXATION FASTENER

Model Number	DX SWIVELOCK, 3.5 X 13.5 MM
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/10/2022
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 contribution of the device to the reported event could not be determined as the device is not expected to be returned for evaluation.The most likely cause for the reported failure can be attributed to user error due to misaligned insertion, improper bone preparation and/or excessive force used when tensioning the sutures.
Event or Problem Description
On 2/11/2022, it was reported by a sales representative via phone that an ar-8990st fibertak was inserted into the patient but the anchor did not seat.Surgeon opened another fibertak and it worked perfectly.During the same procedure, an ar-2324bct-2 4.75 swivelock anchor broke off into the patient's bone when being inserter.Surgeon removed all broken fragments and opened another 4.75 swivelock, however, after removing the inserter, the anchor pulled out of implantation site.A third swivelock was opened to complete that portion of the procedure.Then, while using an ar-8979p dx swivelock, it unraveled from the inserter and pulled out.Surgeon was able to use another swivelock to complete the procedure.This was discovered during a lateral ankle stabilization procedure on (b)(6) 2022.No further issues has been reported.

• Brand Name: DX SWIVELOCK, 3.5 X 13.5 MM
• Common Device Name: NON-DEGRADABLE FIXATION 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: 19192115
• Report Number: 1220246-2024-02461
• Device Sequence Number: 15560077
• Product Code: MBI
• UDI-Device Identifier: 00888867202900
• UDI-Public: 00888867202900
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K150648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/26/2024

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 Expiration Date: 02/28/2026
• Device Model Number: DX SWIVELOCK, 3.5 X 13.5 MM
• Device Catalogue Number: AR-8979P
• Device Lot Number: 12878956
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2022
• Initial Report FDA Received Date: 04/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown