MAUDE Adverse Event Report: ARTHREX, INC. BURR, ROUND, HL, 8 FLUTE, 4.0MM X 19CM; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Catalog Number AR-6400RBE

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/09/2014

Event Type  Injury  

Manufacturer Narrative

Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.This mdr medwatch submission is being done based on a reported event as discovered in a maude/medsun on-line review.No further patient information was provided at the time of this report or made available in response to an foia request.No additional adverse consequences have been reported from this event.This device is used for treatment.The cause of the event could not be determined from the information available and without device evaluation.Lot number was not provided so device history record review cannot be performed.This type of event is typically caused when end user applies excessive force on the device during use.The potential cause(s) of this event cannot be communicated to the original event reporter as this was denied in an foia request.If additional relevant information is received, a follow-up report will be submitted.Unknown device disposition.

Event Description

It was reported in a maude/medsun review that the 4mm burr left shavings in the patient's hip joint when it was used to decorticate the exterior acetabular surface.No further information will be available as the foia request was denied.

• Brand Name: BURR, ROUND, HL, 8 FLUTE, 4.0MM X 19CM
• Type of Device: BUR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 194
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 194
• Manufacturer Contact: vik bajnath, sr. mdr analyst. ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337001
• MDR Report Key: 4174206
• MDR Text Key: 19457175
• Report Number: 1220246-2014-00193
• Device Sequence Number: 1
• Product Code: GFF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: AR-6400RBE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other