MAUDE Adverse Event Report: ARTHREX, INC. 2.5MM DRILL BIT, CALIBRATED

Model Number	2.5MM DRILL BIT, CALIBRATED
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2020
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.The reported event was confirmed as the visual evaluation revealed that the paint groove chipped off partly (see evaluation picture 2).The complaint device was not received for evaluation.Based off the information provided, the most likely cause of the reported failure is wear and tear.
Event or Problem Description
Per loan / consignment inspections operator: during inspection of set 10325519 it was noted that the paint groove chipped.The device was sent in without any customer allegation.There was no harm or adverse event reported by the customer.No further information received.

• Brand Name: 2.5MM DRILL BIT, CALIBRATED
• 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: 19579039
• Report Number: 1220246-2024-06303
• Device Sequence Number: 15576698
• Product Code: HTW
• UDI-Device Identifier: 00888867052239
• UDI-Public: 00888867052239
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/20/2024

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: 2.5MM DRILL BIT, CALIBRATED
• Device Catalogue Number: AR-8943-13
• Device Lot Number: 1391806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown