SYSTEM 5 DUAL TRIGGER ROTARY HANDPIECE 4205000000

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-03-02 for SYSTEM 5 DUAL TRIGGER ROTARY HANDPIECE 4205000000 manufactured by Stryker Instruments-kalamazoo.

Event Text Entries

[5475759] It was reported during set up before a procedure at user facility, the handpiece is overheating and it is running on its own once connected with the battery. The procedure was completed successfully using back-up equipment. No delay, no medical intervention and no adverse consequences were reported with this event.
Patient Sequence No: 1, Text Type: D, B5


[5577438] It was reported during set up before a procedure at user facility that the handpiece is overheating and it is running on its own once connected with the battery. The procedure was completed successfully using back-up equipment. No delay, no medical intervention and no adverse consequences were reported with this event.
Patient Sequence No: 1, Text Type: D, B5


[12936629] The device has been received, failure analysis is in progress; additional information will be submitted once the quality investigation is completed. Failure analysis in progress.
Patient Sequence No: 1, Text Type: N, H10


[13077761] The reported event, handpiece is overheating and runs on its own, was confirmed. Device was repaired and returned to the customer after passing the final inspection.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number0001811755-2015-00735
MDR Report Key4561198
Report Source06
Date Received2015-03-02
Date of Report2015-02-03
Date of Event2015-02-03
Date Mfgr Received2015-03-23
Device Manufacturer Date2004-03-31
Date Added to Maude2015-03-02
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 DUAL TRIGGER ROTARY HANDPIECE
Generic NameINSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT
Product CodeKIJ
Date Received2015-03-02
Returned To Mfg2015-02-05
Catalog Number4205000000
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER INSTRUMENTS-KALAMAZOO
Manufacturer Address4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001


Patients

Patient NumberTreatmentOutcomeDate
10 2015-03-02

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