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

Model Number	DRILL NON-CANNULATED, 4MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 09/27/2024, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-1204d bio-tenodesis¿ screw drill broke.This occurred during a case there was no damage to the patient and no residue was left on the patient.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Correction: b3.Additional information: b5, g3, h6.
Event or Problem Description
Additional information was provided on 10/10/2024 where it was stated that this event occurred during a latarget procedure on (b)(6) 2024.The device broke when drilling into the bone the tip broke.The patient had good quality bone according to the surgeon.All fragments were retrieved.The other drill in the box was used to proceed with the case.
Additional Manufacturer Narrative
Complaint allegation is confirmed per photos provided by the customer that showed the broken drill.Based on the information provided, which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a cause.The most likely cause for the reported failure can be attributed to misaligned insertion; prying/leveraging the device during insertion.

• 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: 20397604
• Report Number: 1220246-2024-08036
• Device Sequence Number: 12327743
• Product Code: HWE
• UDI-Device Identifier: 00888867004450
• UDI-Public: (01)00888867004450(11)230509(10)022318
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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,Followup,Followup
• Report Date (Section B): 01/16/2025

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
• Device Lot Number: 022318
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2024
• Supplement Date Received by Manufacturer: 10/10/2024; 12/20/2024
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 11/15/2024; 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2023
• 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