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

Model Number	DRILL, 2.75MM, .066 CANNULATION
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/11/2023
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 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.
Additional Manufacturer Narrative
The complaint allegation is confirmed.One unpackaged ar-7000-14 serial/batch number (b)(6) was received for evaluation.Functional testing was not performed due to damage to the device.Visual inspection found that the device was broken at the proximal and distal ends.The drill's overall length was measured by drawing specification c1455 at revision 5 (9.00 ±.01).Results.Due to the breakage, the device is shorter, measuring 7.20 in.The observed condition is likely due to prying/levering the device against hard bone or other instrumentation during use.

• Brand Name: DRILL, 2.75MM, .066 CANNULATION
• Common Device Name: 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: jared engle ; 8009337001
• MDR Report Key: 18100330
• Report Number: 1220246-2023-08617
• Device Sequence Number: 7633927
• Product Code: MDM
• UDI-Device Identifier: 00888867040908
• UDI-Public: 00888867040908
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 07/01/2024

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, 2.75MM, .066 CANNULATION
• Device Catalogue Number: AR-7000-14
• Device Lot Number: 022327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2023
• Supplement Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2023
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown