MULTIFIX S-ULTRA 5.5MM KNOTLESS ANCHOR 72290001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-24 for MULTIFIX S-ULTRA 5.5MM KNOTLESS ANCHOR 72290001 manufactured by Arthrocare Corp..

Event Text Entries

[184733767] It was reported that during surgery, the multifix anchor broke when inserting. The procedure was completed without significant delay using a back-up device. No patient injury or other complications were reported. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3006524618-2020-00121
MDR Report Key9873716
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-24
Date of Report2020-04-02
Date of Event2020-02-17
Date Mfgr Received2020-04-01
Device Manufacturer Date2019-10-04
Date Added to Maude2020-03-24
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 FDA3
Event Location3
Manufacturer ContactHOLLY TOPPING
Manufacturer Street7000 WEST WILLIAM CANNON DRIVE
Manufacturer CityAUSTIN TX 78735
Manufacturer CountryUS
Manufacturer Postal78735
Manufacturer Phone5123913905
Manufacturer G1ARTHROCARE CORP.
Manufacturer Street7000 W. WILLIAM CANNON
Manufacturer CityAUSTIN TX 78735
Manufacturer CountryUS
Manufacturer Postal Code78735
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMULTIFIX S-ULTRA 5.5MM KNOTLESS ANCHOR
Generic NameFASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
Product CodeMBI
Date Received2020-03-24
Model Number72290001
Catalog Number72290001
Lot Number2030093
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerARTHROCARE CORP.
Manufacturer Address7000 W. WILLIAM CANNON AUSTIN TX 78735 US 78735


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-24

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