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

Model Number	DRILL ATTACHMENT 2.35MM
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
On 07/28/2022, it was reported by a sales representative via (b)(4) that a ar-300b-2 drill attachment is not attaching correctly to the ar-300m.The burr was not cutting correctly.This occurred during an unknown case, there was no patient effect reported.No additional information provided.
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 contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The most likely cause for the reported failure can be attributed to wear and tear.As no further investigation was able to be performed no change in harm was identified.

• 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: 19469145
• Report Number: 1220246-2024-04939
• Device Sequence Number: 7423935
• Product Code: LXH
• UDI-Device Identifier: 00888867202696
• UDI-Public: 00888867202696
• Combination Product (Y/N): N
• 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): 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 ATTACHMENT 2.35MM
• Device Catalogue Number: AR-300B-2
• Device Lot Number: 11910229
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown