3.5 MM PEEK TWINLOOP FLEX ONE STRAND 2 FORCE FIBER 3910-405-638

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 2011-02-08 for 3.5 MM PEEK TWINLOOP FLEX ONE STRAND 2 FORCE FIBER 3910-405-638 manufactured by Stryker Endoscopy Puerto Rico.

Event Text Entries

[16918893] It was reported that during a case the anchor unit was not seating correctly. Further, during the suturing phase the anchor unit broke. The small fragment was removed, but the anchor remained partially seated in the pt.
Patient Sequence No: 1, Text Type: D, B5


[17120039] Additional information will be provided once the investigation has been completed.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2648666-2011-00030
MDR Report Key2002604
Report Source04
Date Received2011-02-08
Date of Report2011-01-26
Date of Event2011-01-25
Date Mfgr Received2011-01-26
Date Added to Maude2011-06-24
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 ContactSUNNY OFFORJEBE
Manufacturer Street5900 OPTICAL COURT
Manufacturer CitySAN JOSE CA 95138
Manufacturer CountryUS
Manufacturer Postal95138
Manufacturer Phone4087542000
Manufacturer G1STRYKER ENDOSCOPY PUERTO RICO
Manufacturer StreetHWY. 3, KM. 130.2 LAS PALMAS IND. PARK
Manufacturer CityARROYO PR 00615
Manufacturer CountryUS
Manufacturer Postal Code00615
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name3.5 MM PEEK TWINLOOP FLEX ONE STRAND 2 FORCE FIBER
Generic NameANCHOR
Product CodeNOV
Date Received2011-02-08
Catalog Number3910-405-638
Lot Number10336AE2
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSTRYKER ENDOSCOPY PUERTO RICO
Manufacturer AddressARROYO PR 00615 US 00615


Patients

Patient NumberTreatmentOutcomeDate
10 2011-02-08

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