MAUDE Adverse Event Report: ARTHREX, INC. DRILL NON-CANNULATED, 4MM; DRILL BIT

Model Number	DRILL NON-CANNULATED, 4MM
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
On 3/19/2024, it was reported by a sales representative via (b)(4) that an ar-1204d bio-tenodesis screw drill, 4.0 mm (from a loaner set rar-7000s under order (b)(4) was not properly fitted through either coracoid drill guide guide ar-7000-17 or ar-7000-07.It appeared there was a defect in the drill ar-1204d, causing metal shavings to spew out of the drill guide.No drill pieces broke inside the patient, and the case was completed successfully.This was discovered during a latarjet procedure on (b)(6) 2024, with no reported patient harm.Additional information was received on 3/25/2024: it appeared the metal shavings were coming off of the guide, but neither the guide nor the drill broke.The case was completed using an ar-1204d bio-tenodesis screw drill.There was no report of adverse effects on the patient or delay in the case.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Yes.Investigation overall summary: based on the information provided, which may include the device (if available and returned), pictures, videos, event descriptions, and any additional field data, arthrex concluded that the most likely cause of the reported failure is damage to either the mating part or the drill, which causes the device to interact and shave the metal.The complaint allegation was confirmed based on the customer's attached video, where friction is observed when the drill attempts to set inside the mating instrument.

• Brand Name: DRILL NON-CANNULATED, 4MM
• 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: 19105655
• Report Number: 1220246-2024-02018
• Device Sequence Number: 12696923
• Product Code: HWE
• UDI-Device Identifier: 00888867004450
• UDI-Public: 00888867004450
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2025

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 NON-CANNULATED, 4MM
• Device Catalogue Number: AR-1204D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2024
• Supplement Date Received by Manufacturer: 05/17/2025
• Initial Report FDA Received Date: 04/15/2024
• Supplement Report FDA Received Date: 06/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown