5.0MM/4.5MM LCP(TM) UNIVERSAL DRILL SLEEVE 323.500

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-10 for 5.0MM/4.5MM LCP(TM) UNIVERSAL DRILL SLEEVE 323.500 manufactured by Wrights Lane Synthes Usa Products Llc.

MAUDE Entry Details

Report Number2939274-2020-01198
MDR Report Key9813574
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-10
Date of Report2020-02-13
Date Mfgr Received2020-03-20
Device Manufacturer Date2019-06-12
Date Added to Maude2020-03-10
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKARA DITTY-BOVARD
Manufacturer Street1302 WRIGHTS LANE EAST
Manufacturer CityWEST CHESTER PA 19380
Manufacturer CountryUS
Manufacturer Postal19380
Manufacturer Phone6103142063
Manufacturer G1WERK BETTLACH (CH)
Manufacturer StreetMURACHERSTRASSE 3
Manufacturer CityBETTLACH 2544
Manufacturer CountrySZ
Manufacturer Postal Code2544
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand Name5.0MM/4.5MM LCP(TM) UNIVERSAL DRILL SLEEVE
Generic NameGUIDE
Product CodeFZX
Date Received2020-03-10
Returned To Mfg2020-02-20
Model Number323.500
Catalog Number323.500
Lot Number4L77846
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerWRIGHTS LANE SYNTHES USA PRODUCTS LLC
Manufacturer Address1302 WRIGHTS LANE EAST WEST CHESTER PA 19380 US 19380


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-10

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