CANN CONNECTING SCR F/PERCUTAN INSTRUMENTS FOR NAILS-EX 03.010.404

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 2020-03-30 for CANN CONNECTING SCR F/PERCUTAN INSTRUMENTS FOR NAILS-EX 03.010.404 manufactured by Wrights Lane Synthes Usa Products Llc.

Event Text Entries

[185908776] The device has been 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


[185908777] It was reported on march 9, 2020, during an unknown procedure, while the surgeon was using the aiming arm for suprapatellar for proximal interlocks on an expert tibial nail, the drill missed the locking hole through the targeted guide and hit the nail. The guide and drill were removed by utilizing the perfect circles technique. Surgical delay and procedure outcome are unknown. There was no patient consequence. Concomitant devices reported: aiming arm for suprapatellar (part number 03. 010. 441, lot 170039-202, quantity 1), insertion handle suprapatellar (part number 03. 010. 440, lot 180183-101, quantity 1), drill bits: trauma (unknown part number, unknown lot, quantity 1), nails (unknown part number, unknown lot, quantity 1). This report involves one (1) cann connecting scr f/percutan instruments for nails-ex. This is report 2 of 4 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2939274-2020-01605
MDR Report Key9899675
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-30
Date of Report2020-03-09
Date of Event2020-03-09
Date Mfgr Received2020-03-09
Date Added to Maude2020-03-30
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 G1MONUMENT
Manufacturer Street1101 SYNTHES AVENUE
Manufacturer CityMONUMENT CO 80132
Manufacturer CountryUS
Manufacturer Postal Code80132
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCANN CONNECTING SCR F/PERCUTAN INSTRUMENTS FOR NAILS-EX
Generic NameGUIDE
Product CodeFZX
Date Received2020-03-30
Returned To Mfg2020-03-25
Model Number03.010.404
Catalog Number03.010.404
Lot NumberU261953
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 2020-03-30

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