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	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
On (b)(6)2023, it was reported by a sales representative via email that an ar-1941ps peek knotless corkscrew anchor pulled out.The peek knotless corkscrew was inserted into the lateral epicondyle and the bone was prepped using an ar-1941ds instrument kit in standard fashion.The anchor was inserted with no problem, but it pulled out when shuttling the repair stitch through the knotless mechanism.This was discovered during an ecrb debridement and repair procedure on(b)(6)2023.Additional information received on (b)(6)2023: the case was completed using an ar-3636 knotless fibertak.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.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 cause can be attributed misuse due to misaligned insertion; or prying/leveraging the screw during insertion.

• 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: emily shafer ; 8009337001
• MDR Report Key: 17395395
• Report Number: 1220246-2023-07300
• Device Sequence Number: 6054062
• Product Code: MAI
• UDI-Device Identifier: 00888867270794
• UDI-Public: 00888867270794
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2025

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: 08/31/2025
• Device Model Number: 3.9MM KNOTLESS CORKSCREW, PEEK
• Device Catalogue Number: AR-1941PS
• Device Lot Number: 11803356
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2023
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2020
• 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