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 Known Impact Or Consequence To Patient (2692)
Date of Event	06/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number e2015055.  reported events - 6 events were reported for this quarter.Product return status - 6 devices were received for evaluation.Evaluation status - 4 events were confirmed during testing.- 1 device was found to be affected by a mechanical problem.- 2 devices were found to be affected by wear.- 1 device was found to be affected by mechanical shock.2 device evaluations are in progress.Additional information - 6 devices were not labeled for single-use.6 devices were not reprocessed and reused.
Event or Problem Description
This report summarizes 6 malfunction events in which the device had a component detach.6 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: 6 total events were initially reported.2 previously reported events are included in this follow-up record.  product return status 2 devices were received.Evaluation status 1 reported event was confirmed during testing.- 1 device was found to be affected by a broken blade mount assembly.1 device evaluation is in progress.  additional information 6 devices were not labeled for single-use.6 devices were not reprocessed and reused.
Event or Problem Description
This report summarizes 6 malfunction events in which the device had a component detach.6 events had no patient involvement; no patient impact.
Additional Manufacturer Narrative
This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program.Supplemental rationale corrected data: 6 total events were initially reported.6 previously reported events are included in this follow-up record.  product return status 6 devices were received.  event confirmation status 6 reported events were confirmed; the cause traced to component failure.Evaluation results 3 devices were found to be affected by worn internal components.2 devices were found to be affected by mechanical damage.1 device was found to be affected by mechanical shock.
Event or Problem Description
This report summarizes 6 malfunction events in which the device had a component detach.6 events had no patient involvement; no patient impact.

• 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: 8015056
• Report Number: 0001811755-2018-02159
• Device Sequence Number: 19177484
• 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: 6
• 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): 04/24/2019

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: 06/02/2018
• Supplement Date Received by Manufacturer: 06/02/2018; 06/02/2018
• Initial Report FDA Received Date: 10/29/2018
• Supplement Report FDA Received Date: 01/31/2019; 04/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1