MAUDE Adverse Event Report: ARTHREX, INC. 4.5MM QUICK RELEASE DRILL; INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Model Number	4.5MM QUICK RELEASE DRILL
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2022
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 on (b)(6) 2022 by a facility representative via sems that an ar-9239 drill bit broke in the drill guide.This was discovered during a case and broke inside the patient.Per facility: "ar-9239 4.5 drill tip broke off in the vaultlock guide ar-9231-04pp.The piece that broke off was retrieved from the patient but was not retained following the case.The majority of the drill was retained and can be sent in.".
Additional Manufacturer Narrative
Complaint confirmed.Upon visual inspection it was noted that the device had broken.The broken piece was not returned for investigation.Circumferential abrasions were also noted on the shaft of the device.The cause remains undetermined, however, a probable cause can be attributed to prying/leveraging the device during use.

• Brand Name: 4.5MM QUICK RELEASE DRILL
• Common Device Name: INSTRUMENT, MANUAL, SURGICAL, GENERAL USE
• 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: 14469582
• Report Number: 1220246-2022-04955
• Device Sequence Number: 17363018
• Product Code: MDM
• UDI-Device Identifier: 00888867059528
• UDI-Public: 00888867059528
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/30/2022

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: 4.5MM QUICK RELEASE DRILL
• Device Catalogue Number: AR-9239
• Device Lot Number: 021720
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2022
• Supplement Date Received by Manufacturer: 05/02/2022
• Initial Report FDA Received Date: 05/23/2022
• Supplement Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown