MAUDE Adverse Event Report: ARTHREX, INC. CHONDRAL PICK, 30 DEG; MANUAL INSTR, GENERAL SURGICAL

Model Number	CHONDRAL PICK, 30 DEG
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon was attempting to use the chondral picks to perform a micro fracture on patient's talus.Picks would not penetrate bone and just bent out of the way.K-wires were used to complete the case.
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.Complaint confirmed.One unpackaged ar-8656-01, batch 1392109 pick was received for investigation.Visual inspection identified that the shaft of the chondral pick had a significant warp.The thickness of the tip of the pick as well as of the base of the shaft was assessed, and each dimension was found to meet design specifications.The bone quality experienced during the procedure was not recorded.The most likely cause for the reported failure is user error for applying excessive force during use.

• Brand Name: CHONDRAL PICK, 30 DEG
• Common Device Name: MANUAL INSTR, GENERAL SURGICAL
• 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: 19559863
• Report Number: 1220246-2024-05965
• Device Sequence Number: 17825206
• Product Code: MDM
• UDI-Device Identifier: 00888867307445
• UDI-Public: 00888867307445
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 06/18/2024

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: CHONDRAL PICK, 30 DEG
• Device Catalogue Number: AR-8656-01
• Device Lot Number: 1392109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 06/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown