MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 3.0MM PRECISION ROUND; DRILLS, BURRS, TREPHINES & ACCESSORIES

Catalog Number	5820009030
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	04/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Discarded by customer.
Event or Problem Description
It was reported that following a surgical procedure while removing the bur from the attachment the surgeon experienced a minor/small burn to his finger.It was further reported that no treatment was required for the burn and no follow up treatment required.It was further reported that there were no adverse consequences as a result of this event and the procedure was completed successfully using an another device.
Additional Manufacturer Narrative
The reported event, for a temperature issue with the bur, was not confirmed as the bur was not returned for evaluation.Without the bur, the root cause cannot be determined.
Event or Problem Description
It was reported that following a surgical procedure while removing the bur from the attachment the surgeon experienced a minor/small burn to his finger.It was further reported that no treatment was required for the burn and no follow up treatment required.It was further reported that there were no adverse consequences as a result of this event and the procedure was completed successfully using an another device.

• Brand Name: 3.0MM PRECISION ROUND
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8607515
• Report Number: 0001811755-2019-01677
• Device Sequence Number: 2281040
• Product Code: HBE
• UDI-Device Identifier: 04546540670076
• UDI-Public: 04546540670076
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K143320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2019

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 Catalogue Number: 5820009030
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/15/2019
• Supplement Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 05/14/2019
• Supplement Report FDA Received Date: 06/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1