Additional Manufacturer Narrative · 1
THE SUSPECT DEVICE, MAYFIELD 2000 SKULL CLAMP, WAS RECEIVED FROM THE MED CTR ON 9/1/04 AND EVALUATED BY INTEGRA LIFESCIENCES CORP. THE FOLLOWING IS A DOCUMENTED SUMMARY OF THE FINDINGS: EVAL: THE DEVICE WAS RECEIVED IN EXTREMELY POOR CONDITION WITH THE SWIVEL LOCK PARTIALLY DISASSEMBLED AND THE ROCKER ARM STIFF TO MOVE. A CLOSER EXAMINATION OF THE SWIVEL LOCK COMPONENTS REVEALED THE THREAD LOCK ON THE RETAINER WAS LOOSE CAUSING THE LOCK TO PARTIALLY DISSASEMBLE. THE INTERNAL COMPONENTS OF THE SWIVEL LOCK WERE DAMAGED. THIS TYPE OF DAMAGE IS TYPICALLY CAUSED FROM REPEATED CLEANINGS AT ELEVATED TEMPERATURES. THIS DAMAGE CAUSED THE ROCKER ARM TO BECOME STIFF TO MOVE. ACCORDING TO THE CLEANING AND STERILIZATION INSTRUCTIONS FOR THE DEVICE, THE SKULL CLAMP SHOULD NOT BE STEAM STERILIZED. THE PLASTIC COMPONENTS MAY BE DAMGED BY HEAT. CONCLUSION: BASED ON THE NATURE OF THE PROBLEM, INFO PROVIDED BY THE MEDICAL SYSTEM, AND INTEGRA LIFESCIENCES CORP, NO DIRECT CONCLUSION COULD BE DETERMINED AS TO HOW OR WHEN THE DEVICE'S SWIVEL LOCK CAME APART. THE DAMAGE TO THE INTERNAL COMPONENTS OF THE SWIVEL LOCK INDICATED THAT THE DEVICE MAY HAVE BEEN EXPOSED TO REPEATED CLEANINGS AT ELEVATED TEMPERATURES. IN ADDITION, THE DEVICE APPEARED TO HAVE BEEN EXPOSED TO PROLONGED EXTENDED PERIODS WITHOUT ROUTINE GENERAL MAINTENANCE BEING PERFORMED. INTEGRA'S MAINTENANCE RECORD'S INDICATED THAT THE DEVICE HAD NOT BEEN RETURNED FOR MAINTENANCE DURING THE PAST FIVE YEARS. CORRECTIVE ACTION: NO CORRECTIVE ACTION IS REQUIRED BY INTEGRA. HOWEVER, AS AN AID TO THE NEURO SURGERY STAFF AT MEDICAL SYSTEM, INTEGRA WILL SEND A COPY OF THE CD "MAYFIELD PROPER SKULL CLAMP POSITIONING". THE STAFF SHOULD FIND THIS HELPFUL.