PROFIX 750 GRAMS MALLET 71512452

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 2020-02-17 for PROFIX 750 GRAMS MALLET 71512452 manufactured by Smith & Nephew, Inc..

Event Text Entries

[182352508] It was reported that the plastic threads on the mallet were found stripped during surgery. There was no delay in the case. A competitor device was used to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1020279-2020-00570
MDR Report Key9716816
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-02-17
Date of Report2020-02-17
Date of Event2020-01-29
Date Mfgr Received2020-01-29
Device Manufacturer Date2013-12-02
Date Added to Maude2020-02-17
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 ContactDR SARAH FREESTONE
Manufacturer Street1450 BROOKS ROAD
Manufacturer CityMEMPHIS TN 38116
Manufacturer CountryUS
Manufacturer Postal38116
Manufacturer G1SMITH & NEPHEW, INC.
Manufacturer Street1450 BROOKS ROAD
Manufacturer CityMEMPHIS TN 38116
Manufacturer CountryUS
Manufacturer Postal Code38116
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePROFIX 750 GRAMS MALLET
Generic NameINSTRUMENT, MANUAL, SURGICAL, GENERAL USE
Product CodeMDM
Date Received2020-02-17
Returned To Mfg2020-02-08
Model Number71512452
Catalog Number71512452
Lot Number13MM00486
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSMITH & NEPHEW, INC.
Manufacturer Address1450 BROOKS ROAD MEMPHIS TN 38116 US 38116


Patients

Patient NumberTreatmentOutcomeDate
10 2020-02-17

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.