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	12/06/2022
Type of Reportable Event	Serious Injury
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
On (b)(6) 2022, it was reported by a sales representative via email that an mis hand piece broke, and case was unable to be performed additional information received on (b)(6) 2022: this was discovered during an akin procedure on (b)(6) 2022.An ar-300-b201 burr and an oem04364100 irrigation tubing broke, and the case had to be aborted.This was before the case started; however, the patient was already under anesthesia.As of now, procedure has not been rescheduled.

• 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
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 16051574
• Report Number: 1220246-2022-05979
• Device Sequence Number: 20419716
• Product Code: LXH
• UDI-Device Identifier: 00888867028654
• UDI-Public: 00888867028654
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 12/27/2022

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?: No
• 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: 043929
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 12/27/2022
• Date Device Manufactured: 09/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown