MAUDE Adverse Event Report: MEDTRONIC XOMED INC. MICRODEBRIDER BLADES AND BURS; BUR, EAR, NOSE AND THROAT

Model Number XOM UNK M-BUR-BLD

Device Problems Break (1069); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2024

Event Type  malfunction  

Manufacturer Narrative

H3: product analysis found visually, the inner shaft and hub bushing were dislodged and not returned and the hub spring and seal were dislodged from the proximal end of the hub.Additionally, there was a crack on the side of the hub and deformation on the distal outside diameter of the hub.Hub measurements were not taken due to the crack in the hub which would alter precise measurements and 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).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

It was reported that pre-op, the first m5 handpiece did not work when attempted to test it before the patient arrived in the operating room, it was unresponsive when the foot-pedal was engaged. also noticed that the proximal plastic piece of a bur was stuck inside the second m5 handpiece.Another handpiece was used to complete the procedure.There was no patient involvement.As per analysis of the m5 handpiece, bur was stuck in the handpiece which was not intact.

• Brand Name: MICRODEBRIDER BLADES AND BURS
• Type of Device: 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: 19057367
• MDR Text Key: 339883846
• Report Number: 1045254-2024-00506
• Device Sequence Number: 1
• Product Code: EQJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/08/2024

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
• Device Operator: Health Professional
• Device Model Number: XOM UNK M-BUR-BLD
• Device Catalogue Number: XOM UNK M-BUR-BLD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1