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	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the device disassembled during testing prior to a procedure.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.
Additional Manufacturer Narrative
This report was submitted in error.It is a duplicate of mfr report # 0001811755-2020-00350.
Event or Problem Description
The user facility reported that the device disassembled during testing prior to a procedure.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: 9702372
• Report Number: 0001811755-2020-00461
• Device Sequence Number: 11189777
• Product Code: ERL
• UDI-Device Identifier: 07613154495634
• UDI-Public: 07613154495634
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• 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): 04/02/2021

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: 18232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 01/16/2020
• Initial Report FDA Received Date: 02/12/2020
• Supplement Report FDA Received Date: 04/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1