MAUDE Adverse Event Report: ARTHREX, INC. 3.9MM KNOTLESS CORKSCREW, PEEK; BONE FIXATION SCREW/PLATE

Model Number	3.9MM KNOTLESS CORKSCREW, PEEK
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2021
Type of Reportable Event	Malfunction
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.
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 improper bone prep and/or misaligned insertion.As no further investigation was able to be performed no change in harm was identified.

• Brand Name: 3.9MM KNOTLESS CORKSCREW, PEEK
• Common Device Name: BONE FIXATION SCREW/PLATE
• 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: 19286067
• Report Number: 1220246-2024-03083
• Device Sequence Number: 18056918
• Product Code: MAI
• UDI-Device Identifier: 00888867270794
• UDI-Public: 00888867270794
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K193157
• 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): 05/10/2024

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: 3.9MM KNOTLESS CORKSCREW, PEEK
• Device Catalogue Number: AR-1941PS
• 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: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown