MAUDE Adverse Event Report: ARTHREX, INC. 3.0MM DRILL BIT, CANNULATED, REUSEABLE

Model Number	3.0MM DRILL BIT, CANNULATED, REUSEABLE
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during an arthroscopy it was noticed that the kirschner wire does not fit into the drill bit.There was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Complaint allegation is confirmed.Upon visual inspection, it was determined that the distal ends of the flutes of the cannulated drill bit, 3.0 mm (mini hudson), reusable were warped.Functional testing was performed with pin.066, but it did not go through because the tip was damaged.The most likely cause of this failure is wear and tear damage incurred over repeated usage.

• Brand Name: 3.0MM DRILL BIT, CANNULATED, REUSEABLE
• 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: emily shafer ; 8009337001
• MDR Report Key: 18495648
• Report Number: 1220246-2024-00288
• Device Sequence Number: 6984929
• Product Code: HTW
• UDI-Device Identifier: 00888867264038
• UDI-Public: 00888867264038
• 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,Followup
• Report Date (Section B): 08/14/2024

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: 3.0MM DRILL BIT, CANNULATED, REUSEABLE
• Device Catalogue Number: AR-8945-30C-RU
• Device Lot Number: 032042
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2023
• Supplement Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 01/11/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown