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

Catalog Number	6206000000
Medical Device Problem Code	Fail-Safe Problem (2936)
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 : 2 events were reported for this quarter.Product return status : 2 devices were received for evaluation.Evaluation status : 1 event was confirmed during testing, - 1 device was found to be affected by corrosion, 1 device evaluation is in progress.Product disposition : the device was 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 2 malfunction events in which the device experienced a fail-safe problem that could result in unintended activation; 2 events had no patient involvement; no patient impact.
Event or Problem Description
This report summarizes 2 malfunction events in which the device experienced a fail-safe problem that could result in unintended activation.2 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: 1 previously reported event is included in this follow-up record.Evaluation status: 1 reported event was confirmed during testing.1 device was found to be affected by corrosion.1 device is not labeled for single-use.1 device was not reprocessed and reused.

• Brand Name: SYSTEM 6 RECIP
• 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: 7715554
• Report Number: 0001811755-2018-01514
• Device Sequence Number: 13679059
• Product Code: HWE
• UDI-Device Identifier: 07613154392360
• UDI-Public: 7613154392360
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 2
• 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): 10/29/2018

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: 6206000000
• 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: 10/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1