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

Catalog Number	6126120000
Medical Device Problem Code	Fracture (1260)
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: 1 device was received for evaluation.2 devices were available for evaluation but have not yet been received.Evaluation status: 1 reported event was confirmed during testing.1 device was found to be affected by a mechanical problem.Additional information: this device is not labeled for single-use.This device was not reprocessed and reused.
Event or Problem Description
This report summarizes 3 malfunction events in which the device fractured.2 events had no patient involvement; no patient impact.1 event had no known patient involvement or patient impact.
Event or Problem Description
This report summarizes 3 malfunction events in which the device fractured.2 events had no patient involvement; no patient impact.1 event had no known patient involvement or 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 investigation type have not yet been determined.  evaluation status in progress 2 device evaluations are in progress.  additional information 3 devices were not labeled for single-use.3 devices were not reprocessed and reused.
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.3 previously reported events are included in this follow-up record.  product return status 2 devices were received.1 device was not available for evaluation.Event confirmation status 2 reported events were confirmed; the cause traced to component failure.Evaluation results 1 device was found to be affected by corroded contacts.1 device was found to be affected by fractured housing.
Event or Problem Description
This report summarizes 3 malfunction events in which the device fractured.2 events had no patient involvement; no patient impact.1 event had no known patient involvement or patient impact.

• Brand Name: SYSTEM 6 ASEPTIC HOUSING
• 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: 8014409
• Report Number: 0001811755-2018-02006
• Device Sequence Number: 1640121
• Product Code: HWE
• UDI-Device Identifier: 04546540501578
• UDI-Public: 04546540501578
• 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): 04/12/2019

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: 6126120000
• Device Lot Number: E2015055
• 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; 04/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1