MAUDE Adverse Event Report: MEDTRONIC XOMED INC. XPS® BUR GUARD - VISAO®; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Model Number	3334635
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant product: 3334635: visao bur guard with irrigation, lot # 0209970589, manufactured date - aug/10/2015, 510(k) # k983224, (b)(4).The product was returned for analysis.Device evaluation anticipated but not yet begun.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that intraoperative two bur gaurds broke during a com surgery.There was no patient impact.
Additional Manufacturer Narrative
Three opened samples, part number 3334635, from lot numbers 0212018131, 0209970589, and 0209784631 were returned.There was a residue consistent with corrosion on the devices.Of the three samples returned, none of them were specifically identified with a lot number to differentiate.Note: lot numbers 0212018131 <(>&<)> 0209970589 were filed on this regulatory report # 1045254-2017-00117.Lot # 209784631 was filed on regulatory report # 1045254-2017-00118.Visually, the distal end of the irrigation tubes were broken off which would have resulted in the reported event.The portions that broke off were not returned but would have measured approximately 0.90¿ in length.The distal end of the metal irrigation tube is malleable to allow the alignment of the irrigation stream toward the tip of the bur.There was no allegation of damage prior to use.Repeated bending may result in the observed breakage.The instructions for use indicates that the bur guards are ¿semi-reusable components¿.On 2 of the 3 samples, the o-ring inside the proximal end of the guard had multiple notches taken out of the inner edge which is consistent with damage caused the visao handpiece nose cone during multiple loadings / uses.This type of damage can be avoided by twisting the bur guard while installing onto the handpiece.One sample had a missing o-ring.This is a supplied material assembly therefore manufacturing has been ruled out as a likely cause.The information most likely indicates these failures occurred over a period of time from repeated bending.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received indicating that no fragment was dropped inside the patient.The doctor used another bur guard to complete the surgery.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: XPS® BUR GUARD - VISAO®
• Common Device Name: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 6493828
• Report Number: 1045254-2017-00117
• Device Sequence Number: 1049327
• Product Code: ERL
• UDI-Device Identifier: 00885074107363
• UDI-Public: 00885074107363
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K983224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3334635
• Device Catalogue Number: 3334635
• Device Lot Number: 0212018131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2017
• Initial Date Received by Manufacturer: 03/17/2017
• Supplement Date Received by Manufacturer: Not provided; 04/19/2017
• Initial Report FDA Received Date: 04/14/2017
• Supplement Report FDA Received Date: 05/11/2017; 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1