12MM/130 DEG TI CANN TFNA 380MM/LEFT-STERILE 04.037.259S

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 12MM/130 DEG TI CANN TFNA 380MM/LEFT-STERILE 04.037.259S manufactured by Wrights Lane Synthes Usa Products Llc.

Event Text Entries

[186140248] 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


[186140249] It was reported that on (b)(6) 2020, the patient underwent revision surgery due to adverse events. On (b)(6) 2020, the patient presented to the surgeon with pain and was found to have a nonunion of the fracture site and mechanical fatigue of the locking screw and a titanium cannulated proximal femoral nailing system (tfna) long nail. The tfna helical blade, nail, and the lateral segment of the locking screw were removed. No attempt was made to retrieve the medial segment of the locking screw. The non-union site was debrided and a cannulated trochanteric fixation nail, helical blade, and locking screw were inserted. The date of the original implant was on (b)(6) 2019, for a proximal femur fracture. The procedure outcome is unknown. There was a patient consequence. Concomitant device reported: 5. 0mm ti locking screw w/t25 stardrive 40mm f/im nail-ster (part # 04. 005. 530s, lot # h218356. Quantity 1), tfna fenestrated helical blade 100mm - sterile (part # 04. 038. 400s, lot # unknown. Quantity 1), this report is for one (1) 12mm/ 130 deg ti cann tfna 380mm/ left-sterile. This is report 1 of 2 for (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2939274-2020-01593
MDR Report Key9897969
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-30
Date of Report2020-03-03
Date Mfgr Received2020-03-03
Device Manufacturer Date2016-10-28
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
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 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 Name12MM/130 DEG TI CANN TFNA 380MM/LEFT-STERILE
Generic NameROD,FIXATION,INTRAMEDULLARY
Product CodeHSB
Date Received2020-03-30
Returned To Mfg2020-03-20
Model Number04.037.259S
Catalog Number04.037.259S
Lot NumberH218356
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
101. Required No Informationntervention 2020-03-30

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