HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK 72203705

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2020-03-31 for HEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK 72203705 manufactured by Smith & Nephew, Inc..

Event Text Entries

[186231963] It was reported that during an unknown procedure, when turning in the healicoil, it broke just above the tip. Backup device was available to complete the procedure. No significant delay and no patient injuries were reported. 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 Number1219602-2020-00575
MDR Report Key9908243
Report SourceFOREIGN,OTHER
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-05
Date Mfgr Received2020-03-09
Device Manufacturer Date2019-06-05
Date Added to Maude2020-03-31
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 NameHEALICOIL RSB SA 4.75MM W/1 UT & 1 UB BK
Generic NameFASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
Product CodeMAI
Date Received2020-03-31
Catalog Number72203705
Lot Number2034498
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 2020-03-31

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