CLEAR-TRAC COMPLETE 5.5MM X 72MM 7209987

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2006-08-10 for CLEAR-TRAC COMPLETE 5.5MM X 72MM 7209987 manufactured by Smith & Nephew, Inc., Endoscopy Division.

Event Text Entries

[17435203] A piece did break off inside body of pt and they were able to remove most of it. Surgeon introduced the disposable cannula, pushing the cannula into the shoulder joint. When the cannula was in place, he removed the guiding rod from the posterior portal and re-inserted the telescope to carry on with the procedure. It was then discovered that, the tip portion of the disposable was broken. A delay of thirty minutes resulted. Back-up devices were available.
Patient Sequence No: 1, Text Type: D, B5


[17661663] Evaluation of the device showed the distal end of the cannula is broken and small pieces are missing. Condition of the device is consistent with excessive force being applied however, a conclusion could not be made for the reported failure.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1219602-2006-00115
MDR Report Key773688
Report Source01,06,07
Date Received2006-08-10
Date of Report2006-08-10
Date of Event2006-03-20
Date Facility Aware2006-03-20
Report Date2006-08-10
Date Mfgr Received2006-07-10
Date Added to Maude2006-10-30
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 ContactDONNA LATEIGNE
Manufacturer Street150 MINUTEMAN ROAD
Manufacturer CityANDOVER MA 01810
Manufacturer CountryUS
Manufacturer Postal01810
Manufacturer Phone9787491576
Manufacturer G1SMITH & NEPHEW INC.
Manufacturer Street130 FORBES BLVD.
Manufacturer CityMANSFIELD MA 02048
Manufacturer CountryUS
Manufacturer Postal Code02048
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCLEAR-TRAC COMPLETE 5.5MM X 72MM
Generic NameSEARCH OF RECORDS SHOWS
Product CodeNBL
Date Received2006-08-10
Returned To Mfg2006-07-27
Model Number7209987
Catalog Number7209987
Lot NumberUNK
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeUNKNOWN
Device Eval'ed by MfgrY
Implant FlagN
Date RemovedA
Device Sequence No1
Device Event Key761466
ManufacturerSMITH & NEPHEW, INC., ENDOSCOPY DIVISION
Manufacturer Address* ANDOVER MA * US
Baseline Brand NameCLEAR-TRAC COMPLETE 5.5MM X 72MM
Baseline Generic NameSEARCH OF RECORDS SHOWS
Baseline Model No7209987
Baseline Catalog No7209987
Baseline ID*


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2006-08-10

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