MAUDE Adverse Event Report: ARTHREX, INC. DRILL ATTACHMENT 2.35MM; POWERED SURG ORTHOPEDIC INSTR

Model Number	DRILL ATTACHMENT 2.35MM
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device has a weak hold of the burr and the burr was released during the surgery.No piece broke of inside the patient.There was no harm or adverse event for patient, operator or third party reported.The surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.Update avoe 17-feb-2021: it was confirmed that the surgeon noticed the problem outside of the patient.
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.Event description: it was reported that the device has a weak hold of the burr and the burr was released during the surgery.The reported event was confirmed.The manufacturers evaluation revealed a worn clamping system along with a rough bearing in the planetary gear.Furthermore, the device is dirty inside.Based off the information provided, the most likely cause of the reported failure is wear and tear.

• Brand Name: DRILL ATTACHMENT 2.35MM
• 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: 19531982
• Report Number: 1220246-2024-05713
• Device Sequence Number: 7681591
• Product Code: LXH
• UDI-Device Identifier: 00888867202696
• UDI-Public: 00888867202696
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/13/2024

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 ATTACHMENT 2.35MM
• Device Catalogue Number: AR-300B-2
• Device Lot Number: 01047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2021
• Initial Report FDA Received Date: 06/13/2024
• 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