MAUDE Adverse Event Report: ARTHREX, INC. DRILL NON-CANNULATED, 4MM; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	DRILL NON-CANNULATED, 4MM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2022
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
It was reported that a 4.0mm drill was used for a latarjet surgery.This got stuck in the coracoid drill guide (ar-7000-17).According to the surgeon it would not pass through the guide at all.As such it was causing a lot of heat and also caused some minor metal fragments to build up around the guide, a small amount entered the patient but were washed out.There was no harm for patient, operator or third party.The surgery was finished successfully with a 3.5 mm drill instead of a 4.0mm drill.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
One unpackaged ar-1204d, batch number 022146, was received for investigation.Visual evaluation shows no bends of the part.Dimensional measurement of the drill head results in 3.99.Other part measurements were in tolerance by drawing c1404 at revision 11.Visual observation of the drill shows burns on the drill side.Complaint is not confirmed.

• Brand Name: DRILL NON-CANNULATED, 4MM
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• 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: vik bajnath ; 8009337001
• MDR Report Key: 15242810
• Report Number: 1220246-2022-05388
• Device Sequence Number: 11905168
• Product Code: HWE
• UDI-Device Identifier: 00888867004450
• UDI-Public: 00888867004450
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 01/05/2023

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: 022146
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2022
• Supplement Date Received by Manufacturer: 06/09/2022
• Initial Report FDA Received Date: 08/17/2022
• Supplement Report FDA Received Date: 01/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown