MAUDE Adverse Event Report: ARTHREX, INC. PEEK, SWIVELOCK FT, 4.75X19.1MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	PEEK, SWIVELOCK FT, 4.75X19.1MM
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/24/2022
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 most likely cause for the reported failure can be attributed to user error of the device due to excessive force used during suture passing/tightening /tensioning.
Event or Problem Description
On 5/31/20222, it was reported by a sales representative via phone that an ar-2324pct peek swivelock sutures pulled apart and out of the anchor when surgeon was tensioning.The surgeon removed the anchor and all the sutures and used another ar-2324pct peek swivelock to complete the case.This was discovered during an rcr on (b)(6) 2022.

• Brand Name: PEEK, SWIVELOCK FT, 4.75X19.1MM
• 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: 19260879
• Report Number: 1220246-2024-02901
• Device Sequence Number: 20503098
• Product Code: MAI
• UDI-Device Identifier: 00888867098107
• UDI-Public: 00888867098107
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• 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): 05/07/2024

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 FT, 4.75X19.1MM
• Device Catalogue Number: AR-2324PCT
• Device Lot Number: 14710565
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown