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

Model Number	DRILL, 4MM CANNULATED
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on (b)(6) 2022 by a arthrex employee via sems that an ar-1218-40 drill bit broke when it was being used after sterilization.This was discovered during a case within the joint space.
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.
Additional Manufacturer Narrative
Complaint is confirmed.One unpackaged ar-1218-40, drill, 4mm cannulated was received for investigation.Visual evaluation found component c1209-13 cannulate drill body broke off in two pieces at the flutes.Also, it was noticed that the drill's tip had some damage.The observed condition is most likely the result of interference between the device and other instrumentation or bone during use.

• Brand Name: DRILL, 4MM CANNULATED
• 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: 15224068
• Report Number: 1220246-2022-05376
• Device Sequence Number: 14861262
• Product Code: HWE
• UDI-Device Identifier: 00888867087774
• UDI-Public: 00888867087774
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 11/30/2022

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, 4MM CANNULATED
• Device Catalogue Number: AR-1218-40
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2022
• Supplement Date Received by Manufacturer: 07/28/2022
• Initial Report FDA Received Date: 08/15/2022
• Supplement Report FDA Received Date: 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown