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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SMARTLIFE LARGE ASPETIC HOUSING INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

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STRYKER INSTRUMENTS-KALAMAZOO SMARTLIFE LARGE ASPETIC HOUSING INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Model Number 7126-120-000
Device Problem Difficult to Open or Close (2921)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/30/2020
Event Type  Malfunction  
Manufacturer Narrative

This record is a consolidation of records summarized as a part of the fda voluntary malfunction summary reporting program. Reported events: 10 events were reported for this quarter. Product return status: 1 device was received. 9 device investigation types have not yet been determined. Event confirmation status: 1 reported event was confirmed. Evaluation results: 1 device was found to be affected by a swollen o-ring. 10 devices were not labeled for single-use. 10 devices were not reprocessed or reused.

 
Event Description

This report summarizes 10 malfunction events in which the device was reportedly difficult to open or close. 3 events had no patient involvement; no patient impact. 7 events had patient involvement; no patient impact.

 
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Brand NameSMARTLIFE LARGE ASPETIC HOUSING
Type of DeviceINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer Contact
zach baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key10331390
MDR Text Key200624132
Report Number0001811755-2020-01948
Device Sequence Number1
Product Code HWE
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported10
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/29/2021
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/28/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL Number7126-120-000
Device Catalogue Number7126120000
Device LOT NumberVMSR
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/30/2020
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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