MAUDE Adverse Event Report: ARTHREX, INC. CHONDRAL PICK, CONCAVE, 90 DEG; MANUAL INSTR, GENERAL SURGICAL

Model Number	CHONDRAL PICK, CONCAVE, 90 DEG
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2023
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 10/10/2023, it was reported by a sales representative via (b)(4) that an ar-8656-02 chondral pick and an ar-8656-03 chondral pick were producing small metal shavings.This occurred during a case where the debris was retrieved.The devices were switched out and the case was completed.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 complaint is confirmed.Upon visual evaluation, the distal end of the internal curve of the shaft had an abrasion mark.The most likely cause can be attributed to user error of the device due to interference with another device, causing the damage to the shaft.

• Brand Name: CHONDRAL PICK, CONCAVE, 90 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: emily shafer ; 8009337001
• MDR Report Key: 18075515
• Report Number: 1220246-2023-08581
• Device Sequence Number: 7665855
• Product Code: MDM
• UDI-Device Identifier: 00888867307469
• UDI-Public: 00888867307469
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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,Followup
• Report Date (Section B): 11/15/2024

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, CONCAVE, 90 DEG
• Device Catalogue Number: AR-8656-03
• Device Lot Number: 1392243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2023
• Supplement Date Received by Manufacturer: 01/15/2024
• Initial Report FDA Received Date: 11/06/2023
• Supplement Report FDA Received Date: 11/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown