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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SYSTEM 5 RECIPROCATING SAW; INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
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STRYKER INSTRUMENTS-KALAMAZOO SYSTEM 5 RECIPROCATING SAW; INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT Back to Search Results
Catalog Number 4206000000
Device Problem Unintended Ejection (1234)
Patient Problem No Patient Involvement (2645)
Event Date 07/04/2014
Event Type  malfunction  
Event Description
It was reported that during testing prior to a surgical procedure at the user facility, the device would not retain a blade.No medical intervention and no adverse consequences were reported with this event.As this event occurred during testing, there was no patient involvement and no delay to a surgical procedure.
 
Manufacturer Narrative
The reported blade retention issue was confirmed by a manufacturer repair technician through functional evaluation.Upon disassembly, corrosion was found throughout the motor and drivetrain, and it was found that the chuck and yoke assembly were bent, which can lead to the reported event.
 
Event Description
It was reported that during testing prior to a surgical procedure at the user facility, the device would not retain a blade.No medical intervention and no adverse consequences were reported with this event.As this event occurred during testing, there was no patient involvement and no delay to a surgical procedure.
 
Manufacturer Narrative
Failure analysis is in progress; additional information will be submitted once the quality investigation is completed.
 
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Brand Name
SYSTEM 5 RECIPROCATING SAW
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 Key3970180
MDR Text Key4711699
Report Number0001811755-2014-02732
Device Sequence Number1
Product Code KIJ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K972367
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 07/04/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number4206000000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/24/2014
Is the Reporter a Health Professional? No
Date Manufacturer Received08/11/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/11/2005
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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