MAUDE Adverse Event Report: ARTHREX, INC. BURR, STRAIGHT, 19.5MM DIAM. 2.0 MM; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	BURR, STRAIGHT, 19.5MM DIAM. 2.0 MM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2021
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.
Event or Problem Description
It was reported that the device broke during a hallus valgus foot arthroscopy surgery inside the patient.This break was sharp at the base of the cutter head.Further approaches had to be created on the patient to retrieve the head of the device.There was no harm or adverse event for patient, operator or third party reported.The surgery was finished successfully with a new device with the same part number.It was not necessary to do a second surgery.Update 26-feb-2021: the lot number 022206 was provided and was corrected in the case.

• Brand Name: BURR, STRAIGHT, 19.5MM DIAM. 2.0 MM
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11436698
• Report Number: 1220246-2021-02685
• Device Sequence Number: 5170113
• Product Code: LXH
• UDI-Device Identifier: 00888867028654
• UDI-Public: 00888867028654
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: BURR, STRAIGHT, 19.5MM DIAM. 2.0 MM
• Device Catalogue Number: AR-300-B201
• Device Lot Number: 22206
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2021
• Initial Report FDA Received Date: 03/08/2021
• Patient Sequence Number: 1