MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP REMB ELECTRIC MICRO DRILL; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Catalog Number	6400015000
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device overheated during a case at the user facility and a patient received burns to their mouth.No further information was provided by the user facility.
Event or Problem Description
It was reported that the device overheated during a case at the user facility and a patient received burns to their mouth.Upon follow up, the user facility was not able to provide any further information regarding the reported event.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document the device evaluation.

• Brand Name: REMB ELECTRIC MICRO DRILL
• Common Device Name: DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: kelsey barla ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 20632852
• Report Number: 3015967359-2024-02319
• Device Sequence Number: 17990286
• Product Code: ERL
• UDI-Device Identifier: 07613154938254
• UDI-Public: (01)07613154938254
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K112593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2025

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 Catalogue Number: 6400015000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2024
• Supplement Date Received by Manufacturer: 01/06/2025
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2015
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown