MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SYSTEM 6 STERNUM SAW; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	6207000000
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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: seven events were reported for this quarter.Product return status: six devices were received for evaluation.One device was available for evaluation but has not yet been received.Evaluation status: five events were confirmed during testing -three devices were found to be affected by missing components.-two devices were found to be affected by cracked/fractured components.One device evaluation is in progress.Product disposition: five 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 7 malfunction events in which the device had a component detach.Six events had no patient involvement; no patient impact.One event had patient involvement; no patient impact.
Additional Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number e2015055.Supplemental rationale: 2 previously reported events are included in this follow-up record.Product return status: 1 device was available for evaluation but has not yet been received.Evaluation status: 1 reported event was confirmed during testing.1 device was found to be affected by a missing component.2 devices were not labeled for single-use.2 devices were not reprocessed and reused.
Event or Problem Description
This report summarizes 7 malfunction events in which the device had a component detach.6 events had no patient involvement; no patient impact.1 event had 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: 7 total events were initially reported.1 previously reported event is included in this follow-up record.  product return status 1 devices were received.  evaluation status 1 reported event was not confirmed during testing.Additional information  devices were not labeled for single-use.Devices were not reprocessed and reused.
Event or Problem Description
This report summarizes 7 malfunction events in which the device had a component detach.6 events had no patient involvement; no patient impact.1 event had patient involvement; no patient impact.

• Brand Name: SYSTEM 6 STERNUM SAW
• Common Device Name: INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 7715071
• Report Number: 0001811755-2018-01318
• Device Sequence Number: 19086578
• Product Code: HWE
• UDI-Device Identifier: 07613154392704
• UDI-Public: 07613154392704
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 7
• 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): 01/31/2019

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: 6207000000
• 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; 01/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1