1.5/1.1MM DOUBLE DRILL SLEEVE FOR 1.5MM CORTEX SCREWS/RED 03.130.225

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-19 for 1.5/1.1MM DOUBLE DRILL SLEEVE FOR 1.5MM CORTEX SCREWS/RED 03.130.225 manufactured by Wrights Lane Synthes Usa Products Llc.

Event Text Entries

[188666320] Initial reporter is synthes sales representative. The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Patient Sequence No: 1, Text Type: N, H10


[188666321] It was reported on february 20, 2020, during restocking a set, it was noticed that a double drill guide in a va mod hand set was bent. There was no procedure or patient involvement. This report is for one (1) 1. 5/1. 1mm double drill sleeve for 1. 5mm cortex screws/red this is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2939274-2020-01369
MDR Report Key9855896
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-19
Date of Report2020-02-20
Date Mfgr Received2020-02-20
Device Manufacturer Date2018-02-20
Date Added to Maude2020-03-19
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 Name1.5/1.1MM DOUBLE DRILL SLEEVE FOR 1.5MM CORTEX SCREWS/RED
Generic NameGUIDE, SURGICAL, INSTRUMENT
Product CodeFZX
Date Received2020-03-19
Returned To Mfg2020-03-11
Model Number03.130.225
Catalog Number03.130.225
Lot NumberL769052
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrN
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 2020-03-19

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