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

Catalog Number	6400009000
Medical Device Problem Code	Fail-Safe Did Not Operate (4046)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the handpiece vibrated while in safe mode during a case at the user facility.The procedure was completed successfully without a surgical delay; no medical intervention or adverse consequences were reported.
Additional Manufacturer Narrative
Full udi is not available due to missing information (unknown serial number).The device was not returned for evaluation; therefore, a root cause could not be determined for the event.
Event or Problem Description
It was reported that the handpiece vibrated while in safe mode during a case at the user facility.The procedure was completed successfully without a surgical delay; no medical intervention or adverse consequences were reported.

• Brand Name: REMB ELECTRIC HAND SWITCH
• 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: 19836950
• Report Number: 3015967359-2024-01605
• Device Sequence Number: 20802805
• Product Code: ERL
• UDI-Device Identifier: 07613154938230
• UDI-Public: (01)07613154938230
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K112593
• 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): 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: 6400009000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/28/2024
• Supplement Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 07/26/2024
• Supplement Report FDA Received Date: 01/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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