MAUDE Adverse Event Report: ARTHREX, INC. PROFILE DRILL, MINI CMP FT; ARTHROSCOPIC ACCESSORIES

Model Number	PROFILE DRILL, MINI CMP FT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was confirmed as the visual evaluation of the received ar-8737-47 with batch 021834 noted that the distal tip of the returned drill had broken off.The broken pieces were not returned for investigation.A functional test was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to user error of the device due to over-torquing/over-engaging the driver with the screw head.
Event or Problem Description
It was reported that during the surgery to treat a fracture, the device broke and a piece of it became lodged in the patient's bone.This was discovered during an x-ray examination the day after the operation.The broken-off piece remains permanently inside the patient.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with same device was used anyway.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: PROFILE DRILL, MINI CMP FT
• Common Device Name: ARTHROSCOPIC ACCESSORIES
• 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: 23876589
• Report Number: 1220246-2025-05768
• Device Sequence Number: 11954835
• Product Code: NBH
• UDI-Device Identifier: 00888867127241
• UDI-Public: (01)00888867127241(11)180823(10)021834
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 12/23/2025

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: PROFILE DRILL, MINI CMP FT
• Device Catalogue Number: AR-8737-47
• Device Lot Number: 021834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 12/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2018
• 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