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

Catalog Number	6203000000
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	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: 9 events were reported for this quarter.Product return status : 9 devices were received for evaluation.Evaluation status : 8 events were confirmed during testing, - 7 devices were found to be affected by detached/missing components, - 1 device was found to be affected by 3rd party repairs, 1 device evaluation is 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 9 malfunction events in which the device had a component detach; 8 events had no patient involvement; no patient impact; 1 event had patient involvement; no patient impact.
Event or Problem Description
This report summarizes 9 malfunction events in which the device had a component detach.8 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: 9 total events were initially reported.1 previously reported event is included in this follow-up record.  product return status - 1 device was received.  evaluation status confirmed 1 reported event was confirmed during testing.- 1 device was found to be affected by trigger assembly sheared at the cap screws and wear on the release collar.  additional information 9 devices were not labeled for single-use.9 devices were not reprocessed and reused.

• Brand Name: SINGLE 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: 7715560
• Report Number: 0001811755-2018-01497
• Device Sequence Number: 1329654
• Product Code: HWE
• UDI-Device Identifier: 07613154392339
• UDI-Public: 7613154392339
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 9
• 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: 6203000000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/02/2018
• Supplement Date Received by Manufacturer: 03/02/2018
• Initial Report FDA Received Date: 07/24/2018
• 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