MAUDE Adverse Event Report: ARTHREX, INC. STEPDRILL, FOR 3.0MM HCS, LENGTH 10MM; DRILL BIT

Model Number	STEPDRILL, FOR 3.0MM HCS, LENGTH 10MM
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2023
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
It was reported that during a surgery an unknown guide wire got stuck inside the step drill.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
The complaint was confirmed.One unpackaged ar-8610tdc-10 step drill for 3.00mm hcs serial/batch number (b)(6) was received for investigation.The visual evaluation noted a piece of metal inside the drill cannulation and tissue around the metal stuck inside.It was also observed that there were scratches on the dill¿s connector and nick at the drill flutes.The most likely cause(s) of this type of event include applying excessive forces through leveraging/prying the device.

• Brand Name: STEPDRILL, FOR 3.0MM HCS, LENGTH 10MM
• Common Device Name: DRILL BIT
• 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: emily shafer ; 8009337001
• MDR Report Key: 17451899
• Report Number: 1220246-2023-07407
• Device Sequence Number: 7288522
• Product Code: HTW
• UDI-Device Identifier: 00888867197152
• UDI-Public: 00888867197152
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 10/06/2023

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: STEPDRILL, FOR 3.0MM HCS, LENGTH 10MM
• Device Catalogue Number: AR-8610TDC-10
• Device Lot Number: 032237
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2023
• Supplement Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 10/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2022
• 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