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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SMARTLIFE SMALL ASPTC HOUSING; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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STRYKER INSTRUMENTS-KALAMAZOO SMARTLIFE SMALL ASPTC HOUSING; INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Catalog Number 7222120000
Device Problem Biocompatibility (2886)
Patient Problem No Patient Involvement (2645)
Event Date 12/02/2017
Event Type  malfunction  
Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number (b)(4).8 events were reported for this quarter.8 devices were received for evaluation.1 device evaluation is in progress.7 events were confirmed during testing.3 devices were found to be affected by a compromised weld.2 devices were found to be affected by a missing component.1 device was found to be affected by a missing component and a compromised weld.1 device was found to be affected by a film peeling from the door.This device is not repairable and was not returned to the user facility.There were no remedial actions taken.This device is not labeled for single-use.
 
Event Description
This report summarizes 8 malfunction events in which the device had a condition in which the non-sterile battery had the potential to be exposed to the surgical site.1 event had no patient involvement; no patient impact.6 events had patient involvement; no patient impact.1 event had no known patient involvement; no known patient impact.
 
Manufacturer Narrative
This mdr report is part of the malfunction summary reporting program, exemption number e2015055.    supplemental rationale: corrected data: 1 previously reported event is included in this follow-up record.Product return status: 1 device was received for evaluation.  evaluation status: 1 reported event was confirmed during testing.1 device was found to be affected by a compromised weld.  additional information: 1 device is not labeled for single-use.1 device was not reprocessed and reused.
 
Event Description
This report summarizes 8 malfunction events in which the device had a condition in which the non-sterile battery had the potential to be exposed to the surgical site.1 event had no patient involvement; no patient impact.6 events had patient involvement; no patient impact.1 event had no known patient involvement; no known patient impact.
 
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Brand Name
SMARTLIFE SMALL ASPTC HOUSING
Type of Device
INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
MDR Report Key7466548
MDR Text Key107071043
Report Number0001811755-2018-00657
Device Sequence Number1
Product Code HWE
Combination Product (y/n)N
Number of Events Reported8
Summary Report (Y/N)Y
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 10/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number7222120000
Was Device Available for Evaluation? No
Date Manufacturer Received12/02/2017
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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