MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO MICRO DRILL SERIES ANGLED ATTACHMENT; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Model Number	5400015000
Medical Device Problem Codes	Fluid/Blood Leak (1250); Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/15/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the device overheated and was leaking during a procedure.  the patient received a burn from the device.Attempts were made to obtain additional information about the event; no further information has been received.
Additional Manufacturer Narrative
Correction: d10, h3 additional info h6 h3 other text : device not returned.
Event or Problem Description
The user facility reported that the device overheated and was leaking during a procedure.  the patient received a burn from the device.Attempts were made to obtain additional information about the event; no further information has been received.

• Brand Name: MICRO DRILL SERIES ANGLED ATTACHMENT
• Common Device Name: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 10011513
• Report Number: 0001811755-2020-01242
• Device Sequence Number: 16829465
• Product Code: ERL
• UDI-Device Identifier: 04546540401939
• UDI-Public: 04546540401939
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K112593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2020

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: Health Professional
• Device Model Number: 5400015000
• Device Catalogue Number: 5100015252
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/20/2020
• Supplement Date Received by Manufacturer: 10/06/2020
• Initial Report FDA Received Date: 04/29/2020
• Supplement Report FDA Received Date: 10/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1