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

Model Number	5400131000
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer service technician reported that the handle of the device had broken off.The event occurred during functional testing while it was being serviced at the manufacturer facility.There were no adverse consequences related to this event.
Event or Problem Description
The manufacturer service technician reported that the handle of the device had broken off.The event occurred during functional testing while it was being serviced at the manufacturer facility.There were no adverse consequences related to this event.
Additional Manufacturer Narrative
Follow-up report submitted to document device evaluation results.

• Brand Name: CORE, SUMEX HANDSWITCH
• 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: 10600990
• Report Number: 0001811755-2020-02523
• Device Sequence Number: 16442105
• Product Code: ERL
• UDI-Device Identifier: 04546540534132
• UDI-Public: 04546540534132
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 02/18/2021

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: Other
• Device Model Number: 5400131000
• Device Catalogue Number: 5400131000
• Device Lot Number: 20126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Initial Date Received by Manufacturer: 09/03/2020
• Supplement Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 09/29/2020
• Supplement Report FDA Received Date: 02/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1