DRILL FLEXIBLE ENDOSCPC CANN 5MM 72202972

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 2020-03-05 for DRILL FLEXIBLE ENDOSCPC CANN 5MM 72202972 manufactured by Smith & Nephew, Inc..

Event Text Entries

[182218156] It was reported that during an acl reconstruction, metal shavings came off in the joint when surgeon tried to measure the length of the bone hole using the flexible passing pin into the femur through the endo-femoral handled guide and measured the length of the bone hole. There is a possibility that the flexible passing pin was put in and out through the clancy flexible drill, guide several times when measuring the length for bone hole. All pieces were retrieved from the patient and procedure was completed without any patient complications and procedural delay. 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 Number1219602-2020-00468
MDR Report Key9793953
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-05
Date of Report2020-03-05
Date of Event2020-02-06
Date Mfgr Received2020-02-07
Date Added to Maude2020-03-05
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 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 NameDRILL FLEXIBLE ENDOSCPC CANN 5MM
Generic NameACCESSORIES,ARTHROSCOPIC
Product CodeNBH
Date Received2020-03-05
Catalog Number72202972
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
10 2020-03-05

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