3.5MM 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 07 report with the FDA on 2010-01-05 for 3.5MM PEEK TWINLOOP FLEX ONE STRAND 2 FORCE FIBER 3910-405-638 manufactured by Stryker Endoscopy Puerto Rico.

Event Text Entries

[18582170] It was reported that, while using a posterior approach, the doctor inserted the 1st anchor with 12 degree guide to repair posterior labral tear at the 7 o'clock position. After initial insertion into pilot hole by hand he began malleting. Anchor would not advanced past approx 70% insertion. He began to aggressively mallet the anchor and believes that he blew it out through the glenoid. It was further reported that the second anchor was inserted through a 0 degree guide at the 8 o'clock position. After insertion by hand he began malleting but the anchor would not advance. At this point, he did not feel comfortable continuing with this process so he attempted to remove the anchor. Anchor would not detach, so using...
Patient Sequence No: 1, Text Type: D, B5


[18687598] Additional info will be provided once investigation is complete.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2648666-2010-00004
MDR Report Key1580640
Report Source07
Date Received2010-01-05
Date of Report2009-12-08
Date of Event2009-12-08
Date Mfgr Received2009-12-08
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
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 PUERTO RICO, LTD.
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 Name3.5MM PEEK TWINLOOP FLEX ONE STRAND 2 FORCE FIBER
Generic NameANCHOR
Product CodeNOV
Date Received2010-01-05
Catalog Number3910-405-638
Lot NumberUNK
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 2010-01-05

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