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

Catalog Number	5400131000
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that pieces fell out of the device during testing at the user facility.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.The handle may break into small pieces, posing the risk of a small component becoming lost in a surgical site.

• Brand Name: CORE, SUMEX HANDSWITCH
• 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: 20305504
• Report Number: 3015967359-2024-01844
• Device Sequence Number: 21049529
• Product Code: ERL
• UDI-Device Identifier: 04546540534132
• UDI-Public: 04546540534132
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Report Date (Section B): 09/25/2024

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 Catalogue Number: 5400131000
• Device Lot Number: 22298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2022
• 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