MAUDE Adverse Event Report: ARTHREX, INC. PEEK KNOTLESS SUTURETAK, OPEN REPAIR; BIO SOFT TISSUE FIXATN FASTNR

Model Number	PEEK KNOTLESS SUTURETAK, OPEN REPAIR
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/23/2021
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 complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation.
Event or Problem Description
On 11/23/2021, it was reported by a sales representative via email that (2) ar-1938pss peek knotless suturetak anchor and an ar-1941ps peek knotless corkscrew anchor, pulled out from implantation site.This was discovered during an mpfl reconstruction procedure on (b)(6) 2021.When surgeon implanted both suturetak, the anchors pulled out without any resistance.Then, surgeon removed the suturetak anchors and swapped it for the corkscrew anchor but it also pulled out without resistance.Finally, the surgeon had to drill a bone tunnel to achieve adequate fixation and complete case.After receiving additional information on 11/30/2021, sales representative has confirmed that all three failed anchors were removed from the patient and there was not broken pieces left to retrieved.Surgeon completed procedure successfully and patient was not affected.

• Brand Name: PEEK KNOTLESS SUTURETAK, OPEN REPAIR
• 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: 19278866
• Report Number: 1220246-2024-03037
• Device Sequence Number: 20416885
• Product Code: MAI
• UDI-Device Identifier: 00888867290778
• UDI-Public: 00888867290778
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K180594
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/09/2024

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: 11/30/2025
• Device Model Number: PEEK KNOTLESS SUTURETAK, OPEN REPAIR
• Device Catalogue Number: AR-1938PSS
• Device Lot Number: 12214322
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2021
• Initial Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2020
• 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