MICRO SAGITTAL SAW 5400034000

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 2009-08-19 for MICRO SAGITTAL SAW 5400034000 manufactured by Stryker Instruments Kalamazoo.

Event Text Entries

[1233238] It was reported by the customer that the handpiece was leaking oil from the blade mount area. At the time of the observation, the handpiece had not been used in a procedure. No patient involvement. There were no reports of any adverse patient event associated with this malfunction.
Patient Sequence No: 1, Text Type: D, B5


[8477712] The handpiece involved in the reported event was evaluated. During the evaluation, the technician noted the handpiece was leaking black fluid. The handpiece was repaired and returned to the customer.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1811755-2009-00404
MDR Report Key1470936
Report Source06
Date Received2009-08-19
Date of Report2009-07-21
Date of Event2009-07-07
Date Mfgr Received2009-07-21
Device Manufacturer Date2005-01-12
Date Added to Maude2009-12-01
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactMARVIN POWELL
Manufacturer Street4100 EAST MILHAM AVE.
Manufacturer CityKALAMAZOO MI 49001
Manufacturer CountryUS
Manufacturer Postal49001
Manufacturer Phone2693237700
Manufacturer G1STRYKER INSTRUMENTS KALAMAZOO
Manufacturer Street4100 EAST MILHAM AVE.
Manufacturer CityKALAMAZOO MI 49001
Manufacturer CountryUS
Manufacturer Postal Code49001
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMICRO SAGITTAL SAW
Generic NameBONE CUTTING INSTRUMENTS AND ACCESSORIES
Product CodeDWI
Date Received2009-08-19
Returned To Mfg2009-07-21
Model NumberNA
Catalog Number5400034000
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER INSTRUMENTS KALAMAZOO
Manufacturer AddressKALAMAZOO MI 49001 US 49001


Patients

Patient NumberTreatmentOutcomeDate
10 2009-08-19

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