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

Model Number	CHONDRAL PICK, CONCAVE, 90 DEGREE TIP
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 08/25/2022, it was reported by a sales representative via (b)(4) that a ar-8672 chondro 60 degree tip, and a ar-8671 chondro 90 degree tip bent.This occurred during an unknown case.The case was completed, with no patient effect reported.
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.Upon visual inspection, it was observed that the shaft of the pick was significantly bent, indicating that the device had been subjected to prying/leveraging forces.As such, this event is consistent with user-applied mechanical forces to the device during use.

• Brand Name: CHONDRAL PICK, CONCAVE, 90 DEGREE TIP
• 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: 19385685
• Report Number: 1220246-2024-03768
• Device Sequence Number: 6932973
• Product Code: MDM
• UDI-Device Identifier: 00888867044630
• UDI-Public: 00888867044630
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2024

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 DEGREE TIP
• Device Catalogue Number: AR-8671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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