COLLINS RADIOPARENT BLADE 50-8081

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-03-12 for COLLINS RADIOPARENT BLADE 50-8081 manufactured by Codman And Shurtleff - Raynham.

Event Text Entries

[2553847] Affiliate reported that the when the blades were inserted into the retractor body and spread with minor force one of the two blades broke in pieces, the sternum closed suddenly. Affiliate also reported the texture of the blades appeared to be different.
Patient Sequence No: 1, Text Type: D, B5


[9674658] Upon completion of the investigation a follow up report will be filed.
Patient Sequence No: 1, Text Type: N, H10


[10007791] Upon completion of the investigation it was noted that the supplier performed this investigation and during the evaluation process it was found that many used and unused blades were tested and none of which could be broken as described by the customer. It is not possible to determine the exact root cause; however it might be likely that the blades were mis-used. The supplier performed additional testing on the blades to try and determine the actual force needed to break a blade. It was only possible to break a blade when the blade was inserted into the actual metal device at an approximate 30 degree angle. Pressure was applied until the blade broke. The calculation of force required to break the blade was in excess of 250kg, far above the codman specification of 60kg. It was also noted that the blades returned from the customer showed evidence of distortion on one of two key retaining tabs. We suspect the only way this tab can be distorted, is for the blade to be cocked at angle. As a result it is likely that the blade was mis-used.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1226348-2012-00125
MDR Report Key2488505
Report Source01,07
Date Received2012-03-12
Date of Event2012-02-12
Date Mfgr Received2012-03-29
Date Added to Maude2012-03-12
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 FDA0
Event Location0
Manufacturer ContactMR MATTHEW KING
Manufacturer Street325 PARAMOUNT DRIVE
Manufacturer CityRAYNHAM MA 02767
Manufacturer CountryUS
Manufacturer Postal02767
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCOLLINS RADIOPARENT BLADE
Generic NameBLAD, SAW, SURGICAL, CARDIOVASCULAR
Product CodeDWH
Date Received2012-03-12
Returned To Mfg2012-03-21
Catalog Number50-8081
Lot Number120096
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCODMAN AND SHURTLEFF - RAYNHAM
Manufacturer Address325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767


Patients

Patient NumberTreatmentOutcomeDate
10 2012-03-12

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