MAUDE Adverse Event Report: ARTHREX, INC. DRILL JACOBS CHUCK 0-6.5 MM; POWERED SURG ORTHOPEDIC INSTR

Model Number	DRILL JACOBS CHUCK 0-6.5 MM
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 03/18/2022 it was reported by a distributor via (b)(4) that during a procedure, the ar-600dj became disassembled when in reverse and could not be put back together.The ar-600l would not work and is no longer charging.The case was completed with no patient affect.
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 is confirmed based on the customer provided photo, which displays the disassembled ar-600dj.The most likely cause for the reported failure can be attributed to misuse/mishandling due to damage to the device.No change in harm was identified.

• Brand Name: DRILL JACOBS CHUCK 0-6.5 MM
• Common Device Name: POWERED SURG ORTHOPEDIC INSTR
• 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: 19481115
• Report Number: 1220246-2024-04952
• Device Sequence Number: 8048308
• Product Code: HWE
• UDI-Device Identifier: 00888867110878
• UDI-Public: 00888867110878
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/05/2024

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: DRILL JACOBS CHUCK 0-6.5 MM
• Device Catalogue Number: AR-600DJ
• Device Lot Number: 14218931
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2022
• Initial Report FDA Received Date: 06/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2021
• 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