MAUDE Adverse Event Report: MEDTRONIC XOMED INC. XPS® BUR - IPC® M5 AND M4 30K; BUR, EAR, NOSE AND THROAT

Model Number	1883070BLD
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during pre-op blade/bur not seating and the bur was stuck.There was no patient involved.On follow-up, it was reported that the handpiece was a demo device.The device was only borrowed to the customer as backup device.Service and repair found that there was piece of bur in the collet.On further follow-up it was reported that the bur was broken while used on patient and the operator couldn¿t remove the bur after the accident.It¿s difficult to evaluate but probably the rear end.The part that¿s inside the handpiece.No fragments that came off or got detached from the broken device.No fragment get in contact with the patient.
Additional Manufacturer Narrative
Analysis of received bur of product id 1883070bld and lot # 0218906318 found that only portions of the inner assembly were returned.Visually, the inner shaft was bent until broken 0.58 inches from the distal end of the inner hub.There was deformation in the distal outside diameter of the inner hub which would have resulted in the reported event.The outside diameter of the inner hub should be 0.330 ± 0.002 inches and measured 0.329 inches in the undamaged area and up to 0.358 inches in the deformed area which was out of specification.The hub bushing was rough and worn.There was no allegation of difficulty loading the bur or damage prior to use.Functional testing could not be performed due to the broken state of the device.In the returned condition, there was an out of specification condition that was related to the complaint due to physical damage.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Analysis of received bur of product id 1883070bld and lot # 0218906318 found that only portions of the inner assembly were returned.Visually, the inner shaft was bent until broken 0.58 inches from the distal end of the inner hub.There was deformation in the distal outside diameter of the inner hub which would have resulted in the reported event.The outside diameter of the inner hub should be 0.330 ± 0.002 inches and measured 0.329 inches in the undamaged area and up to 0.358 inches in the deformed area which was out of specification.The hub bushing was rough and worn.There was no allegation of difficulty loading the bur or damage prior to use.Functional testing could not be performed due to the broken state of the device.In the returned condition, there was an out of specification condition that was related to the complaint due to physical damage.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during pre-op blade/bur not seating and the bur was stuck.There was no patient involved.On follow-up, it was reported that the handpiece was a demo device.The device was only borrowed to the customer as backup device.Service and repair found that there was piece of bur in the collet.On further follow-up it was reported that the bur was broken while used on patient and the operator couldn¿t remove the bur after the accident.It¿s difficult to evaluate but probably the rear end.The part that¿s inside the handpiece.No fragments that came off or got detached from the broken device.No fragment get in contact with the patient.

• Brand Name: XPS® BUR - IPC® M5 AND M4 30K
• Common Device Name: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: glen belmer ; 6743 southpoint drive north; jacksonville, FL 32216 ; 6122713209
• MDR Report Key: 13616823
• Report Number: 1045254-2022-00114
• Device Sequence Number: 5215911
• Product Code: EQJ
• UDI-Device Identifier: 00643169434622
• UDI-Public: 00643169434622
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/28/2022

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: 1883070BLD
• Device Catalogue Number: 1883070BLD
• Device Lot Number: 0218906318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2022
• Initial Report FDA Received Date: 02/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown