MAUDE Adverse Event Report: ARTHREX INC. BONE CUTTER, 4.0MM X 13CM; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	AR-8400BC
Health Effect - Clinical Code	Injury (2348)
Date of Event	03/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.The potential causes of this event are being communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that the bone cutter broke in the hub during surgery.All broken pieces were retrieved from the patient.However, the patient was burnt.Opened another bone cutter and completed the procedure.Shoulder scope.Follow up information: sales rep was notified about the incident on (b)(4) 2013.It has been reported that the account/nursing director did not know the means of how the patient was burnt.Account reported to the sales rep that the burn was located at one of the incisions portals on the anterior aspect of the shoulder.It was reported to be a minor superficial burn which was treated per facility policy.Patient was discharged same day.
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 inner shaft is broken-off at the proximal end, and the outer shaft was severely bent at the proximal end.The inner tube's material type was within specification.Typically this type of event is caused by excessive bending forces applied to the device during use.The potential causes of this event are being communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that the bone cutter broke in the hub during surgery.All broken pieces were retrieved from the patient.However, the patient was burnt.Opened another bone cutter and completed the procedure.Shoulder scope.Follow up information: sales rep was notified about the incident on 4/11/13.It has been reported that the account/nursing director did not know the means of how the patient was burnt.Account reported to the sales rep that the burn was located at one of the incisions portals on the anterior aspect of the shoulder.It was reported to be a minor superficial burn which was treated per facility policy.Patient was discharged same day.

• Brand Name: BONE CUTTER, 4.0MM X 13CM
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7483540
• Report Number: 1220246-2018-00162
• Device Sequence Number: 1630390
• Product Code: GFA
• UDI-Device Identifier: 00888867043466
• UDI-Public: 00888867043466
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2018

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: 10/01/2022
• Device Catalogue Number: AR-8400BC
• Device Lot Number: 10171119
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/11/2018
• Supplement Date Received by Manufacturer: 04/11/2018
• Initial Report FDA Received Date: 05/03/2018
• Supplement Report FDA Received Date: 06/19/2018
• 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