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

Model Number	5400050000
Medical Device Problem Codes	Electrical Power Problem (2925); Unintended Electrical Shock (4018)
Health Effect - Clinical Code	Shock (2072)
Date of Event	06/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the device shocked the user during testing prior to a procedure.There was no user or patient impact, no delay, no medical intervention, and no adverse consequences.
Event or Problem Description
The user facility reported that the device shocked the user during testing prior to a procedure.There was no user or patient impact, no delay, no medical intervention, and no adverse consequences.
Additional Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.

• Brand Name: CORE MOTOR CONTROLLER
• 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: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 17271414
• Report Number: 3015967359-2023-01414
• Device Sequence Number: 5086082
• Product Code: ERL
• UDI-Device Identifier: 07613153011781
• UDI-Public: 07613153011781
• 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: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2023

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: 5400050000
• Device Catalogue Number: 5400050000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/27/2023
• Supplement Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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