5.5MM TITANIUM INTRALINE 2 FORCE FIBER 3910-400-050

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2009-12-17 for 5.5MM TITANIUM INTRALINE 2 FORCE FIBER 3910-400-050 manufactured by Stryker Endoscopy Puerto Rico.

Event Text Entries

[1274196] It was reported that "while implanting, anchor broke about halfway". The broken piece was retrieved and the rest of the anchor was left in the patient.
Patient Sequence No: 1, Text Type: D, B5


[8512560] Additional information will be provided once investigation is complete.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2648666-2009-00357
MDR Report Key1579411
Report Source04
Date Received2009-12-17
Date of Report2009-11-19
Date of Event2009-11-10
Date Mfgr Received2009-11-19
Date Added to Maude2010-08-04
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationUNKNOWN
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactNILA PATEL
Manufacturer Street5900 OPTICAL COURT
Manufacturer CitySAN JOSE CA 95138
Manufacturer CountryUS
Manufacturer Postal95138
Manufacturer Phone4087542000
Manufacturer G1STRYKER ENDOSCOPY PUERTO RICO
Manufacturer StreetHIGHWAY #3, KM 130.2 LAS PALMAS INDUSTRIAL PARK
Manufacturer CityARROYO PR 00615
Manufacturer CountryUS
Manufacturer Postal Code00615
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name5.5MM TITANIUM INTRALINE 2 FORCE FIBER
Generic NameANCHOR
Product CodeNOV
Date Received2009-12-17
Returned To Mfg2009-12-02
Catalog Number3910-400-050
Lot Number09218AE2
OperatorOTHER
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER ENDOSCOPY PUERTO RICO
Manufacturer AddressARROYO PR 00615 US 00615


Patients

Patient NumberTreatmentOutcomeDate
10 2009-12-17

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