KARLIN SPINAL CURRETTES

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-02-06 for KARLIN SPINAL CURRETTES manufactured by Codman.

Event Text Entries

[781403] The surgery department noted that their spinal currette handles had lost their color and finish. The handles had become a gray color and were rough to touch. In the process of contacting a local company to repair the handles, the surgery department was told that these handles are made of cast aluminum attached to stainless steel shafts and blades. Instruments made with dissimilar metals or lying on one another in an autoclave will set up a battery. Pitting and corrosion will result when water, chemicals and heat are introduced. Transference of the aluminum particles will contaminate instruments made of stainless steel. The aluminum instrument handles were originally anodized - chemically coated with a thin layer of colored die. - this process is to keep aluminum from corroding. When the anodized surface is penetrated, either by wear or corrosion, aluminum oxide is exposed. Aluminum oxide is a toxic substance suspected of causing alzheimer's and some cancers. The aluminum fragments from these instrument handles are powdering off and contaminating the surgical wound and should not be used in surgery. The currettes have been removed from service and are being replaced with new ones. Triple enzyme detergent concentrate is the detergent used to clean surgical instruments now versus neutral ph detergent concentrate that was used in the past. Getinge powercon neutral ph detergent concentrate used for washing surgical instruments may have contributed to the corrosion process that occurred to these spinal currettes. The ph value of the product is 7. 0-8. 0.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5005354
MDR Report Key997154
Date Received2008-02-06
Date of Report2008-02-06
Date of Event2008-01-28
Date Added to Maude2008-02-22
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Sequence Number: 1

Brand NameKARLIN SPINAL CURRETTES
Generic NameSPINAL CURRETTES
Product CodeHTF
Date Received2008-02-06
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Implant FlagN
Date RemovedB
Device Sequence No1
Device Event Key968731
ManufacturerCODMAN

Device Sequence Number: 2

Brand NameV-MUELLER SPINAL CURRETTES
Generic NameSPINAL CURRETTES
Product CodeHTF
Date Received2008-02-06
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Implant FlagN
Date RemovedB
Device Sequence No2
Device Event Key968760
ManufacturerCARDINAL HEALTH


Patients

Patient NumberTreatmentOutcomeDate
101. Deathisabilit 2008-02-06

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