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When extracting a tenxor frame, the surgeon saw that the wire posts were cracked in the fitting to the wire.The rep checked with the clinic again and found that the hardware damage was discovered after removal, in the cleaning process.It is not known when the damage occurred.The patient was not involved in the event, and this event had no impact on the patient.This was not a revision surgery.The damaged tenxor frame did not have any impact on the patient.
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The reported event that wire post tenxor was alleged of 'implant breakage after surgery' could be confirmed.The event was noticed when the frame was removed from the patient after that the device fulfilled its intended purpose.It was noticed that the wire blocker is cracked/broken.Marks of usages and wear are visible and the device was manufactured in 2005, more than 11 years before reported event.We don¿t know how and how many times this device was reprocessed but it was not found defective during the 11 previous years.Therefore this case is classified as user related due to a poor reprocessing.Please note that the cleaning and sterilization guide (ot-rg-1 rev 3_l24002000 cleaning guide) reads: ''inspection: before preparing for sterilization, all medical devices should be inspected.Generally un-magnified visual inspection under good light conditions is sufficient.All parts of the devices should be checked for visible soil and/or corrosion.Particular attention should be paid to: soil ¿traps¿ such as mating surfaces, hinges, shafts of flexible reamers.Recessed features (holes, cannulations).Features where soil may be pressed into contact with the device, e.G.Drill flutes adjacent to the cutting tip, sides of teeth on broaches and rasps.Cutting edges should be checked for sharpness and damage.For devices that may be impacted check that the device is not damaged to the extent that it malfunctions or that burrs have been produced that could damage tissues or surgical gloves.Functional checks should be performed where possible: mating devices should be checked for proper assembly.Medical devices with moving parts should be operated to check correct operation (medical grade lubricating oil suitable for steam sterilization can be applied as required).Rotating instruments (e.G.Multiple use drill bits, reamers) should be checked for straightness (this can be achieved by simply rolling the instrument on a flat surface).¿flexible¿ instruments, e.G.Im reamers, should be checked for damage to the spiral element.Note: stryker trauma & extremities typically does not specify the maximum number of uses appropriate for re-usable medical devices.The useful life of these devices depends on many factors including the method and duration of each use, and the handling between uses.Careful inspection and functional test of the device before use is the best method of determining the end of serviceable life for the medical device.However, for certain instruments end of life has been defined, verified and specified with either a number of uses or an expiration date.See appendix 2 for further details.[page 8]'' [original statement(s)].A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.
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When extracting a tenxor frame, the surgeon saw that the wire posts were cracked in the fitting to the wire.The rep checked with the clinic again and found that the hardware damage was discovered after removal, in the cleaning process.It is not known when the damage occurred.The patient was not involved in the event, and this event had no impact on the patient.This was not a revision surgery.The damaged tenxor frame did not have any impact on the patient.
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