CLAMPING FOOT FOR 328.040 LCP? 3.5MM AND LC-DCP? 3.5MM 325.041

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 2020-03-17 for CLAMPING FOOT FOR 328.040 LCP? 3.5MM AND LC-DCP? 3.5MM 325.041 manufactured by Wrights Lane Synthes Usa Products Llc.

Event Text Entries

[188675868] 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


[188675869] It was reported that on february 19, 2020, the clamping foot broke during open reduction internal fixation (orif) of the femur. There were no fragments generated from the broken device. There was no surgical delay. Procedure was successfully completed. Patient outcome was good. This complaint involves one (1) device. This is 1 of 1 for report (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2939274-2020-01313
MDR Report Key9844801
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-17
Date of Report2020-02-19
Date of Event2020-02-19
Date Mfgr Received2020-02-19
Device Manufacturer Date2009-06-18
Date Added to Maude2020-03-17
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 ContactKARA DITTY-BOVARD
Manufacturer Street1302 WRIGHTS LANE EAST
Manufacturer CityWEST CHESTER PA 19380
Manufacturer CountryUS
Manufacturer Postal19380
Manufacturer Phone6103142063
Manufacturer G1WERK H
Manufacturer StreetIM BIFANG 6
Manufacturer CityHAEGENDORF 4614
Manufacturer CountrySZ
Manufacturer Postal Code4614
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCLAMPING FOOT FOR 328.040 LCP? 3.5MM AND LC-DCP? 3.5MM
Generic NameGUIDE
Product CodeFZX
Date Received2020-03-17
Returned To Mfg2020-03-06
Model Number325.041
Catalog Number325.041
Lot Number3150713
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 2020-03-17

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