MAUDE Adverse Event Report: ARTHREX, INC. BURR, ROUND, FLUTE; BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Catalog Number	AR-7300RBE
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/13/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at ti me 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 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.Device history record review revealed nothing relevant to this event.This is the second complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.Device requested but not yet received.
Event or Problem Description
It was reported that during a bilateral elbow arthroscopy, the shaver blade stopped rotating.Surgery was finished successfully but surgeon had to use a manual burr and arthroscopy forceps to finish the subtotal coronoidectomy.Due to the switch of the surgical technique, operation took considerably longer than using the shaver.Anesthesia of the patient was stable and prolonged use did not cause any harm to the patient.

• Brand Name: BURR, ROUND, FLUTE
• Common Device Name: BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 5823523
• Report Number: 1220246-2016-00306
• Device Sequence Number: 346519
• Product Code: GFA
• UDI-Device Identifier: 00888867041967
• UDI-Public: 00888867041967
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 07/08/2016

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: 10/01/2020
• Device Catalogue Number: AR-7300RBE
• Device Lot Number: 10010638
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/26/2016
• 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