MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO CORE OSCILLATING SAW

Catalog Number	5400031000
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/05/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the device was disassembled during testing prior to a procedure.There was no patient involvement, no delay, no medical intervention, and no adverse consequences.

• Brand Name: CORE OSCILLATING SAW
• Common Device Name: CORE OSCILLATING SAW
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 8043826
• Report Number: 0001811755-2018-02369
• Device Sequence Number: 1585394
• Product Code: ERL
• UDI-Device Identifier: 04546540401946
• UDI-Public: 04546540401946
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/06/2018

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: 5400031000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2018
• Initial Report FDA Received Date: 11/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1