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

Catalog Number	AR-300-B201
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.The device was requested/is expected for evaluation but has not yet been received.The cause of the event could not be determined from the information available and without device evaluation.Device history record review revealed nothing relevant to this event.Complainant's event typically caused by user mechanical damage to device such as hitting the device with another device or excessive bending forces being applied during use.The potential causes of this event are being communicated to the event reporter.If the device is returned and additional information is obtained, a follow-up report will be submitted.
Event or Problem Description
It was reported that during surgery the burr broke.Because of that incident the surgeon had to switch to an open technique and was using the saw.The surgery was completed successfully with the saw.There was no harm for patient, user or third party.Follow-up investigation: the tip of burr broke and was not retrieved.The tip will remain inside the drill hole which is secured by a titan anchor.
Event or Problem Description
It was reported that during surgery the burr broke.Because of that incident the surgeon had to switch to an open technique and was using the saw.The surgery was completed successfully with the saw.There was no harm for patient, user or third party.Follow-up investigation: the tip of burr broke and was not retrieved.The tip will remain inside the drill hole which is secured by a titan anchor.
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.Device history record review revealed nothing relevant to this event.Complaint confirmed.The evaluation revealed that the device's tip was broken-off.Complainant's event typically caused by user mechanical damage to device such as hitting the device with another device or excessive bending forces being applied during use.The potential causes of this event are being communicated to the event reporter.If the device is returned and additional information is obtained, a follow-up report will be submitted.

• 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: 7302197
• Report Number: 1220246-2018-00067
• Device Sequence Number: 2274005
• Product Code: LXH
• UDI-Device Identifier: 00888867028654
• UDI-Public: 00888867028654
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2018

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 Expiration Date: 03/01/2022
• Device Catalogue Number: AR-300-B201
• Device Lot Number: 131650
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/05/2018
• Supplement Date Received by Manufacturer: 02/05/2018
• Initial Report FDA Received Date: 02/28/2018
• Supplement Report FDA Received Date: 03/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other