MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO DUAL TRIGGER ROTARY HANDPIECE; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Catalog Number	6205000000
Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Code	No Patient Involvement (2645)
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 - 3 events were reported for this quarter.Product return status - 3 devices were received for evaluation.Evaluation status - 1 reported event was confirmed during testing.- 1 device was found to be affected by third party modifications to the e-box.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 3 malfunction events in which the device had run-on.3 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 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 confirmed 1 reported event was confirmed during testing.- 1 device was found to be affected by an e-box failure.In progress 1 device evaluation is 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 3 malfunction events in which the device had run-on.3 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: 3 total events were initially reported.3 previously reported events are included in this follow-up record.  product return status 3 devices were received.  event confirmation status 2 reported events were confirmed; the cause traced to component failure.1 device evaluation is still in progress.Evaluation results 2 devices were found to be affected by electrical component problem.
Event or Problem Description
This report summarizes 3 malfunction events in which the device had run-on.3 events had no patient involvement; no patient impact.

• Brand Name: DUAL TRIGGER ROTARY HANDPIECE
• 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: 8013872
• Report Number: 0001811755-2018-01833
• Device Sequence Number: 16486045
• Product Code: HWE
• UDI-Device Identifier: 07613154392698
• UDI-Public: 07613154392698
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 3
• 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 a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Catalogue Number: 6205000000
• 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