MAUDE Adverse Event Report: ARTHREX, INC. DRILL BIT, 1.7MM

Model Number	DRILL BIT, 1.7MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 16 july 2024, it was reported by a sales representative via email that both an ar-8916-14 drill bit, 1.7mm and an ar-18700-54 driver shaft, t8, self retaining, ao, broke during use.This occurred on (b)(6) 2024 in flinders medical centre during a navicular orif.Using arthrex equipment for open reduction internal fixation 1.7mm drill bit (ref: ar-8916-14) snapped at drill tip.2.4mm t8 screwdriver (ref: ar-18700-54) snapped while screwing locking screw into locking plate.Ar-18724p-54 plate removed from patient as screw thread secured into plate and unable to be removed.All arthrex stock removed and discarded.The case was completed successfully using a synthes va foot set.There was case involvement.
Additional Manufacturer Narrative
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 most likely cause.The most likely cause for the reported failure can be attributed to improper bone prep; misaligned insertion; prying/leveraging the device during use.

• Brand Name: DRILL BIT, 1.7MM
• 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: 19960673
• Report Number: 1220246-2024-07132
• Device Sequence Number: 7136916
• Product Code: HTW
• UDI-Device Identifier: 00888867048942
• UDI-Public: 00888867048942
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2024

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: DRILL BIT, 1.7MM
• Device Catalogue Number: AR-8916-14
• Device Lot Number: 032338
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2024
• Supplement Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2023
• 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