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

Model Number	2.5MM DRILL BIT, CALIBRATED
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that from the loan position vk-14261-calc-fx-pl // 404963018 two instruments were not usable.These are the articles ar-8954-07+ ar-8943-42 from the dls-calc-fx-pl-in / 10151881.There was no harm or adverse event for patient, operator or third party reported.No further information received.
Additional Manufacturer Narrative
Complaint not confirmed.Upon visual inspection, no problem was noted with the device.

• 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: 19299708
• Report Number: 1220246-2024-03198
• Device Sequence Number: 14956550
• Product Code: HTW
• UDI-Device Identifier: 00888867052499
• UDI-Public: 00888867052499
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 05/13/2024

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: 2.5MM DRILL BIT, CALIBRATED
• Device Catalogue Number: AR-8943-42
• Device Lot Number: 031507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2022
• Initial Report FDA Received Date: 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown