MAUDE Adverse Event Report: ARTHREX, INC. DRILL, 2.75MM, .066 CANNULATION; MANUAL INSTR, GENERAL SURGICAL

Model Number DRILL, 2.75MM, .066 CANNULATION

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/11/2023

Event Type  malfunction  

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 Description

On 10/16/2023, it was reported by a sales representative via email that an ar-7000-14 2.75 mm drill broke off inside the patient right after the first ar-7000-26ft cannulated screw, fully threaded was placed.A c-arm was brought in to locate the broken fragment.Once the fragment was found, the surgeon was unable to retrieve it.The surgeon retained the broken fragments using another ar-7000-26ft cannulated screw, fully threaded, which was manually implanted since there was no other drill available to implant the rest of the screw.This was discovered during a distal tibial allograft placement on the shoulder on (b)(6) 2023.The case was delayed for about thirty minutes.

• Brand Name: DRILL, 2.75MM, .066 CANNULATION
• Type of Device: MANUAL INSTR, GENERAL SURGICAL
• 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: emily shafer ; 8009337001
• MDR Report Key: 18100330
• MDR Text Key: 327736442
• Report Number: 1220246-2023-08617
• Device Sequence Number: 1
• Product Code: MDM
• UDI-Device Identifier: 00888867040908
• UDI-Public: 00888867040908
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DRILL, 2.75MM, .066 CANNULATION
• Device Catalogue Number: AR-7000-14
• Device Lot Number: 022327
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/14/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1