MAUDE Adverse Event Report: ARTHREX, INC. STEPDRILL, FOR 2.5MM HCS, LENGTH 30MM; BIT, DRILL

Model Number	STEPDRILL, FOR 2.5MM HCS, LENGTH 30MM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2021
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 the drill broke off.There was no harm for patient, operator or third party reported.No further information received.29-nov-2021 update: further information was provided that the reported event occurred during a surgery.30-nov-2021 update dw: further information were provided that the reported event occurred on (b)(6) 2021.It was further reported that the hallux valgus - scarf surgery could be finished successfully with another device with the same part number.The surgeon (b)(6)was able to retrieve everything out of the patient.
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 the drill broke off.There was no harm for patient, operator or third party reported.No further information received.29-nov-2021 update: further information was provided that the reported event occurred during a surgery.30-nov-2021 update dw: further information were provided that the reported event occurred on (b)(6) 2021.It was further reported that the hallux valgus - scarf surgery could be finished successfully with another device with the same part number.The surgeon (b)(6)was able to retrieve everything out of the patient.

• Brand Name: STEPDRILL, FOR 2.5MM HCS, LENGTH 30MM
• Common Device Name: BIT, DRILL
• 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: 12954200
• Report Number: 1220246-2021-04077
• Device Sequence Number: 4257551
• Product Code: HTW
• UDI-Device Identifier: 00888867197145
• UDI-Public: 00888867197145
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• 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
• Report Date (Section B): 12/07/2021

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 2.5MM HCS, LENGTH 30MM
• Device Catalogue Number: AR-8610TDC-03
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2021
• Initial Report FDA Received Date: 12/07/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown