MED NARROW BLD (25.0MM X5.5MM) 5400003414

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 2010-03-10 for MED NARROW BLD (25.0MM X5.5MM) 5400003414 manufactured by Stryker Ireland Ltd..

Event Text Entries

[1292639] It was reported that a blade tooth broke off during a bunionectomy. It was further reported that it was not possible to retrieve the tooth from the pt and that an x-ray performed on the pt did not detect the presence of the tooth. No adverse consequences were reported.
Patient Sequence No: 1, Text Type: D, B5


[8444923] The blade subject to this mdr was returned for eval. It was visually confirmed that a blade tooth had broken off. The root cause for this breakage has not been determined.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number9616696-2010-00203
MDR Report Key1634257
Report Source07
Date Received2010-03-10
Date of Report2010-02-08
Date of Event2010-02-08
Date Mfgr Received2010-02-08
Device Manufacturer Date2009-08-21
Date Added to Maude2010-12-02
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional0
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactUNA BARRY
Manufacturer StreetCARRIGTWOHILL BUSINESS & TECHNOLOGY PARK
Manufacturer CityCARRIGTWOHILL, CORK
Manufacturer CountryEI
Manufacturer Phone214532963
Manufacturer G1STRYKER IRELAND LTD.
Manufacturer StreetCARRIGTWOHILL BUSINESS & TECHNOLOGY PARK
Manufacturer CityCARRIGTWOHILL, CORK
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMED NARROW BLD (25.0MM X5.5MM)
Generic NameSAW BLADES AND ACCESSORIES
Product CodeDWH
Date Received2010-03-10
Returned To Mfg2010-03-08
Catalog Number5400003414
Lot Number09233017
Device Expiration Date2014-08-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER IRELAND LTD.
Manufacturer AddressCARRIGTWOHILL, CORK EI


Patients

Patient NumberTreatmentOutcomeDate
10 2010-03-10

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