MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO ELECTRIC HANDSWITCH- LEFT HANDED; DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Model Number	5400121000S1
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/21/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer sales representative reported that the device had paint chips missing during testing prior to a procedure at the user facility.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.
Additional Manufacturer Narrative
The initial report was filed in error.This device does not have paint or a colored band; as such, there is no potential for paint chips to be flaked off and missing from this device.
Event or Problem Description
The manufacturer sales representative reported that the device had paint chips missing during testing prior to a procedure at the user facility.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.

• Brand Name: ELECTRIC HANDSWITCH- LEFT HANDED
• 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: 9717254
• Report Number: 0001811755-2020-00468
• Device Sequence Number: 16233574
• Product Code: ERL
• UDI-Device Identifier: 07613154495634
• UDI-Public: 07613154495634
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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): 04/20/2020

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: 5400121000S1
• Device Catalogue Number: 5400121000S1
• Device Lot Number: 12094
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/21/2020
• Supplement Date Received by Manufacturer: 04/17/2020
• Initial Report FDA Received Date: 02/17/2020
• Supplement Report FDA Received Date: 04/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1