MAUDE Adverse Event Report: ARTHREX, INC. DRILL, 7MM CANNULATED; DRILL BIT

Model Number	DRILL, 7MM CANNULATED
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a knee surgery the end of the drill bit broke inside the patients knee while drilling the femoral tunnel.All parts were retrieved from the patient.Per complaint reporter 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
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The reported event was confirmed as the visual evaluation of the received ar-1207l with batch 022302 noted that the tip of the drill is broken off over a length of 15 mm (see evaluation pictures 3 - 5).The broken pieces were returned for investigation.A functional test was not performed due to the damage to the device.According to product management, the most likely cause for the reported event can be attributed to misuse.If the drill is already in contact with the bone during use and is only then set in rotation, high torque is generated, which can lead to metal parts shearing off.

• Brand Name: DRILL, 7MM 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: 22385926
• Report Number: 1220246-2025-02706
• Device Sequence Number: 9075674
• Product Code: HWE
• UDI-Device Identifier: 00888867005020
• UDI-Public: (01)00888867005020(11)230120(10)022302
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2025

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: DRILL, 7MM CANNULATED
• Device Catalogue Number: AR-1207L
• Device Lot Number: 022302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2025
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 06/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown