BLADE/SCREW GUIDE SLEEVE 03.037.017

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 2020-03-25 for BLADE/SCREW GUIDE SLEEVE 03.037.017 manufactured by Wrights Lane Synthes Usa Products Llc.

Event Text Entries

[186752638] Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. 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


[186752639] It was reported that on an unknown date, the grooves on the blade screw or guide sleeve was damaged and the compression buttress nut will not freely spin up and down grooves. It is unknown if there was a patient involvement. This report is for one (1) blade/screw guide sleeve this is report 1 of 1 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2939274-2020-01519
MDR Report Key9879137
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-25
Date of Report2020-02-26
Date Mfgr Received2020-02-26
Date Added to Maude2020-03-25
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 NameBLADE/SCREW GUIDE SLEEVE
Generic NameGUIDE, SURGICAL, INSTRUMENT
Product CodeFZX
Date Received2020-03-25
Model Number03.037.017
Catalog Number03.037.017
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
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 2020-03-25

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