MAUDE Adverse Event Report: ARTHREX, INC. DRILL, 9MM CANNULATED; DRILL BIT

Model Number	DRILL, 9MM CANNULATED
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2022
Type of Reportable Event	Malfunction
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 after the first time in the sterilizer, there is immediately strong discoloration and some markings have already disappeared.The reported event was confirmed as the visual evaluation revealed that the lasere marks are slightly faded and showing signs of metal surface oxidation (see evaluation picture 2 - 4).The most likely cause for the reported failure can be attributed to user error of the device due to improper detergent/cleaning process used.
Event or Problem Description
It was reported that after the first time in the sterilizer, there is immediately strong discoloration and some markings have already disappeared.There was no harm or adverse event for patient, operator or third party reported.No further information received.

• Brand Name: DRILL, 9MM CANNULATED
• Common Device Name: DRILL BIT
• 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: 19473227
• Report Number: 1220246-2024-04941
• Device Sequence Number: 4036013
• Product Code: HWE
• UDI-Device Identifier: 00888867005082
• UDI-Public: 00888867005082
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• 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, 9MM CANNULATED
• Device Catalogue Number: AR-1209L
• Device Lot Number: 25292138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2022
• Initial Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2021
• 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