MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 4.0MM ROUND DIAMOND; DRILLS, BURRS, TREPHINES & ACCESSORIES

Model Number	5820012040D
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting return of device to manufacturer.
Event or Problem Description
It was reported that during a surgical procedure, the bur got hot and discoloured.It was also reported there were no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.
Event or Problem Description
It was reported that during a surgical procedure, the bur got hot and discoloured.It was also reported there were no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.
Additional Manufacturer Narrative
H6; the bur reported involved in this event was returned for evaluation.On receipt of the bur the reported discoloration of the bur was observed.The bur was evaluated by product engineering who concluded that the bur head was covered heavily with soft tissue and this would reduce the cut efficiency contributing to the heat experienced by the customer.A lack of irrigation may have caused the soft tissue built up on the bur head.The attachments for use with this bur instructions for use(ifu) were reviewed and contain the following warning "always use adequate irrigation during cutting to prevent heat generation.".

• Brand Name: 4.0MM ROUND DIAMOND
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 10154887
• Report Number: 0001811755-2020-01464
• Device Sequence Number: 2102033
• Product Code: HBE
• UDI-Device Identifier: 07613327294781
• UDI-Public: 07613327294781
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K143320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2020

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: No Information
• Device Model Number: 5820012040D
• Device Catalogue Number: 5820012040D
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• Initial Date Received by Manufacturer: 06/03/2020
• Supplement Date Received by Manufacturer: 07/30/2020
• Initial Report FDA Received Date: 06/15/2020
• Supplement Report FDA Received Date: 07/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1