SYSTEM 5 SINGLE TRIGGER ROTARY HANDPIECE 4203000000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-05-22 for SYSTEM 5 SINGLE TRIGGER ROTARY HANDPIECE 4203000000 manufactured by Stryker Instruments-kalamazoo.

Event Text Entries

[5839199] It was reported during service at manufacturer facility that device is running in wrong mode. It oscillated when forward trigger was pressed. No associated procedure, no patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
Patient Sequence No: 1, Text Type: D, B5


[5877198] It was reported during service at manufacturer facility that device is running in wrong mode. It oscillated when forward trigger was pressed. No associated procedure, no patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.
Patient Sequence No: 1, Text Type: D, B5


[13317144] Through service, the service technician found that the device oscillated when it was supposed to run in the forward direction. Upon disassembly, a non-stryker asic motor controller and motor were found. The asic motor controller and motor were replaced along with other suggested components. Device was returned to the customer after passing the final inspection.
Patient Sequence No: 1, Text Type: N, H10


[13402266] Failure analysis is in progress; additional information will be submitted once the quality investigation is completed.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number0001811755-2015-01865
MDR Report Key4792360
Report Source07
Date Received2015-05-22
Date of Report2015-04-29
Date of Event2015-04-29
Date Mfgr Received2015-06-05
Device Manufacturer Date2002-10-20
Date Added to Maude2015-05-22
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMR. CASEY METZGER
Manufacturer Street4100 EAST MILHAM AVENUE
Manufacturer CityKALAMAZOO MI 49001
Manufacturer CountryUS
Manufacturer Postal49001
Manufacturer Phone2693237700
Manufacturer G1STRYKER INSTRUMENTS-KALAMAZOO
Manufacturer Street4100 EAST MILHAM AVENUE
Manufacturer CityKALAMAZOO MI 49001
Manufacturer CountryUS
Manufacturer Postal Code49001
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSYSTEM 5 SINGLE TRIGGER ROTARY HANDPIECE
Generic NameINSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Product CodeKIJ
Date Received2015-05-22
Returned To Mfg2015-04-28
Catalog Number4203000000
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER INSTRUMENTS-KALAMAZOO
Manufacturer Address4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001


Patients

Patient NumberTreatmentOutcomeDate
10 2015-05-22

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