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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO ASEPTIC BATTERY HOUSING; INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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STRYKER INSTRUMENTS-KALAMAZOO ASEPTIC BATTERY HOUSING; INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Catalog Number 4126120000
Device Problems Disassembly (1168); Battery Problem (2885)
Patient Problem No Patient Involvement (2645)
Event Date 04/01/2014
Event Type  malfunction  
Event Description
It was reported that the aseptic housing fractured and detached from the top housing to the aseptic bottom housing where battery is placed during inspection at user facility.No associated procedure, no patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
 
Event Description
It was reported that the aseptic housing fractured and detached from the top housing to the aseptic bottom housing where battery is placed during inspection at user facility.No associated procedure, no patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
 
Manufacturer Narrative
The device has not been received at the manufacturer for testing. an evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.
 
Manufacturer Narrative
The reported event, housing was fractured apart, was duplicated.The technician confirmed that the housing was fractured, the guide rails were broken, and the housing lid was discolored due to improper sterilization.A chemical attack can occur as a result of improper cleaning practices, including improper rinsing, use of improper concentration of a basic disinfectant.Device was placed in parts retention.
 
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Brand Name
ASEPTIC BATTERY HOUSING
Type of Device
INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-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
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key3798939
MDR Text Key4368652
Report Number0001811755-2014-01653
Device Sequence Number1
Product Code KIJ
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K972367
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 04/11/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/08/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number4126120000
Device Lot Number12136
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/04/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/17/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/15/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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