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

Catalog Number	AR-8500CRE
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/17/2016
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 for evaluation but was not returned 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.If additional relevant information is received, a follow-up report will be submitted.Typically this type of event is caused by excessive bending forces applied to the device during use.Device history record review revealed nothing relevant to this event.This is the first 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.
Event or Problem Description
It was originally reported that the customer returned a shaver/burr with a broken tip.No item or lot# provided at that time, no more information provided by customer.The sales rep reported that the tip of a shaver broke during surgery and tip remained in patient's body as it could not be removed.Additional information obtained 07-july-2016: it was reported that the protection cap at the tip of the burr got lost during the surgery.The protection cap was not returned for evaluation.Customer could not confirm that protection cap was left inside of patient's body.Surgery performed was a hip ask.Surgery was successfully finished using another burr with the same item number.Date of surgery was (b)(6) 2016.
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.Complaint confirmed.The device met all material specification as received.The evaluation of the returned device revealed that the clear hood broke-off at the distal end of the device's outer tube.Observed deep scratches and gouges on surface of outer tube where the clear hood was attached.Also, the outer and inner tubes are severely bent.Complainant's event typically caused when end user applied excessive bending/leveraging force on the hood during use.This is the first 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.
Event or Problem Description
It was originally reported that the customer returned a shaver/burr with a broken tip.No item or lot number provided at that time, no more information provided by customer.The sales rep reported that the tip of a shaver broke during surgery and tip remained in patient's body as it could not be removed.Additional information obtained 07-july-2016: it was reported that the protection cap at the tip of the burr got lost during the surgery.The protection cap was not returned for evaluation.Customer could not confirm that protection cap was left inside of patient's body.Surgery performed was a hip ask.Surgery was successfully finished using another burr with the same item number.Date of surgery was (b)(6) 2016.

• 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: 5823519
• Report Number: 1220246-2016-00307
• Device Sequence Number: 16229987
• Product Code: GFA
• UDI-Device Identifier: 00888867043787
• UDI-Public: 00888867043787
• 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,Followup
• Report Date (Section B): 08/09/2016

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: 09/01/2020
• Device Catalogue Number: AR-8500CRE
• Device Lot Number: 10012893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/26/2016
• Supplement Report FDA Received Date: 08/09/2016
• 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