MAUDE Adverse Event Report: ARTHREX, INC. STEP DRL,2.4MM/3.0MM TISSTAK/BIO-S-TAK; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Model Number	STEP DRL,2.4MM/3.0MM TISSTAK/BIO-S-TAK
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2022
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 during a knee arthroscopy the drill broke off at the back part and inside the patient.The broken piece was retrieved from patient.There was no harm for patient, operator or third party.The surgery was finished successfully with the same device was used anyway.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Complaint confirmed.One unpackaged ar-1250lt was received for investigation.Visual inspection identified that the step feature had broken off of the shaft of the drill, and was not returned for analysis.The outer diameter of the remainder of the shaft was assessed using digital micrometer id: 244, and was found to meet design specifications.A probable cause is attributed to user-applied mechanical forces, such as prying/leveraging the drill during use.

• Brand Name: STEP DRL,2.4MM/3.0MM TISSTAK/BIO-S-TAK
• 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: 14135454
• Report Number: 1220246-2022-04738
• Device Sequence Number: 4706099
• Product Code: HWE
• UDI-Device Identifier: 00888867006287
• UDI-Public: 00888867006287
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 05/04/2022

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: STEP DRL,2.4MM/3.0MM TISSTAK/BIO-S-TAK
• Device Catalogue Number: AR-1250LT
• Device Lot Number: 10252129
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2022
• Supplement Date Received by Manufacturer: 03/29/2022
• Initial Report FDA Received Date: 04/18/2022
• Supplement Report FDA Received Date: 05/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown