MAUDE Adverse Event Report: MEDTRONIC XOMED INC. XPS® BLADE; BUR, EAR, NOSE AND THROAT

Model Number	1884380HR
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received, however the product analysis is not yet complete.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 during four separate cases, the ¿teeth¿ broke off the blade and into the patient.All parts were retrieved.Each case will be reported separately.This report is for case 1 of 4.Medtronic internal reference numbers: (b)(4) - 1 of 4, (b)(4) - 2 of 4, (b)(4) - 3 of 4, (b)(4) - 4 of 4.
Additional Manufacturer Narrative
The product analysis indicates that three opened samples were received.A microscope, calipers, ipc console in conjunction with an m4 handpiece, and scale were used to analyze the devices.There was a residue consistent with biological contaminants on all 3 devices.This facility reported 4 events and was asked for clarification regarding the quantities, part numbers and lot numbers associated with the events.The only definitive information they could provide was that they were quadcut blades.Since it cannot be determined what product goes with what event this analysis will be for all 3 samples and the results duplicated on each of the 4 events.The reported product for all events was part 1884380em, from lot number 0212672064 however what we received was the following: 1) part number 1884380hr, from lot number 0212545010.(b)(4) part number 1884380em, from lot number 0212661404.(b)(4) 3) part number 1884380em, from lot number 0212672064.(b)(4)(1884380hr - lot number 0212545010) the inner shaft broke 0.65¿ from the distal face of the inner hub which would have resulted in the reported malfunction.The break point corresponds to the proximal end of the outer tube in the front hub.When viewed under magnification, there was deformation of the locking area on the front hub and striations around the outside diameter of the break point indicating metal on metal contact.The information indicates excess pressure was applied during use which caused the deformation of the locking area, which then caused the inner shaft and outer tube to rub together until the inner shaft broke.There was no indication of device fragments and the breakage would have been contained by the outer tube and the handpiece.The ifu warns that excessive pressure applied to a bur/blade may cause a fracture.Note: [excess: exceeded sufficient pressure required for operation].2.(1884380em - lot number 0212661404) visually the inner and outer assemblies were bent.When viewed under magnification, there was damage to the hubs that is consistent with improper loading: dimples on the front hub prior to the locking area caused by the handpiece locking mechanism, locking area damage caused by the back side of the front collet of the handpiece, and damage to the inner hub chevrons caused by the handpiece drive mechanism.The inner shaft broke 0.67¿ from the distal face of the inner hub and striations around the outside diameter of the break point indicating metal on metal contact.There was no indication of device fragments and the breakage would have been contained by the outer tube and the handpiece.The ifu has detailed instructions for properly loading a bur/blade into the handpiece.There were no loose components.Improperly loading a blade into a handpiece would result in the reported complaint.3.(1884380em - lot number 0212672064) visually, there was no damage or anomalies in the construction of the device that would have resulted in the reported event.There were no bends, no fragments, no loose components.The irrigation and suction was tested using a syringe with no issue.Functionally, the blade was run at 5000 rpm in oscillate mode/direction, and cut saw bone with no issues.There was no fault found.
Event or Problem Description
It was reported that during an endoscopic sinus surgery, the ¿teeth¿ broke off the blade and into the patient.Additional information provided indicates that the debris/fragment(s) were suctioned out.All parts were retrieved.There was no patient injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: XPS® BLADE
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 6429753
• Report Number: 1045254-2017-00096
• Device Sequence Number: 1202448
• Product Code: EQJ
• UDI-Device Identifier: 00643169209367
• UDI-Public: 00643169209367
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K130608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/28/2017

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 Expiration Date: 01/02/2021
• Device Model Number: 1884380HR
• Device Catalogue Number: 1884380HR
• Device Lot Number: 0212545010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2017
• Initial Date Received by Manufacturer: 02/28/2017
• Supplement Date Received by Manufacturer: Not provided; 03/27/2017
• Initial Report FDA Received Date: 03/23/2017
• Supplement Report FDA Received Date: 04/20/2017; 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 106