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 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 - 1 reported event was confirmed during testing.- 1 device was found to be affected by a fractured and sheared trigger assembly.5 device evaluations are in progress.Additional information - this device is not labeled for single-use.This device was 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.5 previously reported events are included in this follow-up record.  product return status 5 devices were received.  evaluation status confirmed 5 reported events were confirmed during testing.- 5 devices were found to be affected by damaged and missing internal components.  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.

• 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: 8016745
• Report Number: 0001811755-2018-02276
• Device Sequence Number: 16554253
• 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: 6
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

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