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

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	03/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number e2015055.Reported events: ten (10) events were reported for this quarter.Product return status: ten (10) devices were received for evaluation.Evaluation status: seven (7) events were confirmed during testing.Seven (7) devices were found to be affected by detached and missing components.Three (3) device evaluations are in progress.Product disposition: the devices were repaired and returned to the user facility.Additional information: there were no remedial actions taken on this device.This device is not labeled for single-use.
Event or Problem Description
This report summarizes 10 malfunction events in which the device had a component detach.Ten (10) events had no patient involvement; no patient impact.
Additional Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number e2015055.  supplemental rationale corrected data: 3 previously reported events are included in this follow-up record.Evaluation status 1 reported event was confirmed during testing.- 1 device was found to be affected by damage to the output link.2 device evaluations are in progress.Additional information 3 devices were not labeled for single-use.3 devices were not reprocessed and reused.
Event or Problem Description
This report summarizes 10 malfunction events in which the device had a component detach.10 events had no patient involvement; no patient impact.
Event or Problem Description
This report summarizes 10 malfunction events in which the device had a component detach.10 events had no patient involvement; no patient impact.
Additional Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number e2015055.Supplemental rationale corrected data: 10 total events were initially reported.10 previously reported events are included in this follow-up record.  product return status 10 devices were received.Evaluation status 10 reported events were confirmed during testing.- 10 devices were found to be affected by a damaged blade mount assembly.  additional information 10 devices were not labeled for single-use.10 devices were not reprocessed and reused.

• Brand Name: CORE OSCILLATING SAW
• 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: 7714918
• Report Number: 0001811755-2018-01235
• Device Sequence Number: 1065296
• Product Code: ERL
• UDI-Device Identifier: 04546540401946
• UDI-Public: 04546540401946
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 10
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/14/2019

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: No Information
• Device Catalogue Number: 5400031000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/02/2018
• Supplement Date Received by Manufacturer: 03/02/2018; 03/02/2018
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 10/29/2018; 03/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1