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

Catalog Number	5400120000S1
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The manufacturer sales representative reported that the device was leaking during testing at the user facility.There were no adverse consequences related to this event.
Additional Manufacturer Narrative
The reported event of leaking was not confirmed.Upon disassembly, there were no observed failures that could lead to the reported event.Based on previous similar complaints, possible causes could be related to cleaning practices outside of the manufacturer recommendations; however, this was not confirmed.
Event or Problem Description
The manufacturer sales representative reported that the device was leaking during testing at the user facility.There were no adverse consequences related to this event.

• Brand Name: CORE MODIFIED SABER DRILL
• 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: 8307686
• Report Number: 0001811755-2019-00472
• Device Sequence Number: 1063835
• Product Code: ERL
• UDI-Device Identifier: 07613154284436
• UDI-Public: 07613154284436
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K112593
• 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): 04/19/2019

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 Catalogue Number: 5400120000S1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Initial Date Received by Manufacturer: 01/08/2019
• Supplement Date Received by Manufacturer: 04/16/2019
• Initial Report FDA Received Date: 02/05/2019
• Supplement Report FDA Received Date: 04/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1