MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 1.6MM CROSS-CUT FISSURE CARBIDE BUR; BUR, EAR, NOSE AND THROAT

Model Number 2296101216

Device Problem Break (1069)

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

Event Date 09/03/2020

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be filed once the quality investigation is complete.Awaiting return of device to manufacturer.

Event Description

It was reported that during a surgical procedure, the bur broke.It was also reported that a fragment of the bur remained in the patients jaw as a result of this event.It was further reported that the bur was removed as part of medical intervention.It was also reported that the procedure was completed successfully.

Event Description

It was reported that during a surgical procedure, the bur broke.It was also reported that a fragment of the bur remained in the patients jaw as a result of this event.It was further reported that the bur was not removed and no medical intervention was performed.It was also reported that the procedure was completed successfully.

Manufacturer Narrative

B5; no medical intervention was performed in this case.The procedure was completed successfully.H6: the quality investigation is complete.

• Brand Name: 1.6MM CROSS-CUT FISSURE CARBIDE BUR
• Type of Device: BUR, EAR, NOSE AND THROAT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 11225117
• MDR Text Key: 241236766
• Report Number: 0001811755-2021-00384
• Device Sequence Number: 1
• Product Code: EJL
• UDI-Device Identifier: 04546540046161
• UDI-Public: 04546540046161
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2020
• Device Model Number: 2296101216
• Device Catalogue Number: 2296101216
• Device Lot Number: 15349017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2021
• Initial Date Manufacturer Received: 12/30/2020
• Initial Date FDA Received: 01/25/2021
• Supplement Dates Manufacturer Received: 03/19/2021
• Supplement Dates FDA Received: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention