FLEX DRILL BIT 8400-FD03

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-07 for FLEX DRILL BIT 8400-FD03 manufactured by Microport Orthopedics Inc..

Event Text Entries

[27804335] This report will be updated when investigation is complete. Trends will be evaluated. This event occurred in (b)(6).
Patient Sequence No: 1, Text Type: N, H10


[27804336] Allegedly, the instrument was broken easily. Surgery time extended greater than 30 minutes.
Patient Sequence No: 1, Text Type: D, B5


[31768499] The complaint database was reviewed and analysis showed no trend for item/lot.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number3010536692-2015-01823
MDR Report Key5132146
Date Received2015-10-07
Date of Report2015-10-06
Date of Event2015-08-18
Date Facility Aware2015-08-18
Date Mfgr Received2015-11-16
Date Added to Maude2015-10-07
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 FDA0
Report to FDA3
Event Location3
Manufacturer Street5677 AIRLINE ROAD
Manufacturer CityARLINGTON TN 38002
Manufacturer CountryUS
Manufacturer Postal38002
Manufacturer Phone9018674771
Manufacturer G1MICROPORT ORTHOPEDICS INC.
Manufacturer Street5677 AIRLINE RD.
Manufacturer CityARLINGTON TN 38002
Manufacturer CountryUS
Manufacturer Postal Code38002
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFLEX DRILL BIT
Generic NameHIP INSTRUMENT
Product CodeLXI
Date Received2015-10-07
Returned To Mfg2015-10-02
Catalog Number8400-FD03
Lot Number6396190001
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMICROPORT ORTHOPEDICS INC.
Manufacturer Address5677 AIRLINE RD. ARLINGTON TN 38002 US 38002


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2015-10-07

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