MAUDE Adverse Event Report: ARTHREX, INC. PEEK SWIVELOCK, 3.9X17.9MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	PEEK SWIVELOCK, 3.9X17.9MM
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2021
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 was not returned/received for evaluation.The most likely cause for the reported failure can be attributed to use error.
Event or Problem Description
It was reported that a 3.9 mm peek swivelock would not advance into the prepared socket.A 4.0 mm socket was drilled and the anchor would still not advance.

• Brand Name: PEEK SWIVELOCK, 3.9X17.9MM
• 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: 19444681
• Report Number: 1220246-2024-04662
• Device Sequence Number: 7165169
• Product Code: MAI
• UDI-Device Identifier: 00888867289154
• UDI-Public: 00888867289154
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/02/2024

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: PEEK SWIVELOCK, 3.9X17.9MM
• Device Catalogue Number: AR-2326PSLC
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2021
• Initial Report FDA Received Date: 06/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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