MAUDE Adverse Event Report: ARTHREX, INC. SWIVELOCK, SP PEEK KL 4.75MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	SWIVELOCK, SP PEEK KL 4.75MM
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6)2023 it was reported by a sales representative via phone that an ar-2324kpsp 4.75 mm peek knotless swivelock backed out.This occurred during an all procedure on (b)(6)2023 when the inserter was pulled out, and the knotless mechanism was also pulled out.The eyelet stayed in the patient, but the anchor was removed.The case continued using a second ar-2324kpsp and drilling a little deeper.There was no harm to the patient.The patient had a good hard bone prepared for insertion using the drill from an ar-1593-p implant system.
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
Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely causes of the reported failure are improper bone preparation, misaligned insertion, and prying/leveraging the device during insertion.

• Brand Name: SWIVELOCK, SP PEEK KL 4.75MM
• 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: emily shafer ; 8009337001
• MDR Report Key: 18049632
• Report Number: 1220246-2023-08510
• Device Sequence Number: 8254766
• Product Code: MAI
• UDI-Device Identifier: 00888867384552
• UDI-Public: 00888867384552
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K222263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2024

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 PEEK KL 4.75MM
• Device Catalogue Number: AR-2324KPSP
• Device Lot Number: 15087038
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2023
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 11/01/2023
• Supplement Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2023
• 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