HANDLE UNIVERSAL ENDOFEMORAL AIMER 72201732

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-30 for HANDLE UNIVERSAL ENDOFEMORAL AIMER 72201732 manufactured by Smith & Nephew, Inc..

Event Text Entries

[186149729] (b)(6).
Patient Sequence No: 1, Text Type: N, H10


[186149731] It was reported that, during an acl reconstruction, metal sheddings were seen coming off in the joint. This was noticed in the femoral tunnel while the universal handle was in contact with the passing pin. Most of the metal sheddings were removed from the knee joint with a mechanical shaver. The procedure was completed with the same universal handle. There was no significant delay reported. The patient's outcome is as expected. All available information has been disclosed. If additional information should become available, a supplemental report will be submitted accordingly.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1219602-2020-00568
MDR Report Key9901355
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-30
Date of Report2020-03-30
Date of Event2020-02-07
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
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactHOLLY TOPPING
Manufacturer Street7000 WEST WILLIAM CANNON DRIVE
Manufacturer CityAUSTIN TX 78735
Manufacturer CountryUS
Manufacturer Postal78735
Manufacturer Phone5123913905
Manufacturer G1SMITH & NEPHEW, INC.
Manufacturer Street130 FORBES BOULEVARD
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal Code02048
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameHANDLE UNIVERSAL ENDOFEMORAL AIMER
Generic NameACCESSORIES,ARTHROSCOPIC
Product CodeNBH
Date Received2020-03-30
Model Number72201732
Catalog Number72201732
Lot NumberUNKNOWN
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerSMITH & NEPHEW, INC.
Manufacturer Address130 FORBES BOULEVARD MANSFIELD MA 02048 US 02048


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-30

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