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(b)(4).We have been able to identify the root cause of this situation as a mishap (human error).Therefore, the relevant colleague has been reminded to review fda reporting guidelines in order to prevent this from happening again.The reported incident involves the left hand side of our cm-acc06-1 folding safety sides were purchased in september 2008, there has not been an actual incident as the side was found in this condition and reported by the customer.So there is no actual incident date however we were made aware of the issue on the (b)(6) 2011 meaning the accessory has been in use for (b)(6) years and we are not aware of any other problems with the safety side prior to this issue being reported.The same hinge moulding and fixing screw have been in use since 2002 and are used in a number of applications across the range of safety sides manufactured by the company, the normal configuration for these sides is three rails which means six pivot points/hinge joints per side and twelve per bed.The fixing screw in question is n ejot screw which is a thread forming screw specially developed for joints in thermoplastic materials, the thread geometry creates low surface pressure and provides for a high clamp force in the assembly.This particular model of safety side has been in the market place since 2004, as a compatible accessory for the minuet ii community bed and is ce marked according to the requirements of the medical devices directive eec 93/42.We have now reviewed the alleged faulty part and can find no reason for the screw to have partially unscrewed out of the hinge moulding.We have type tested this product to 30,000 cycles without any issues of screws working themselves loose, the specified head of ejot screw is a t drive so that it would be relatively tamper proof.The construction of the hinge joint pivot on the central bars is such that no load is exerted on the screws which could create a turning moment as the side is operated.We have still been able tightened to secure the screw in the plastic moulding.We have reviewed the rotational movement of the safety side as it goes from the down to the upright position and vice versa and could not detect any rotational movement on the fixing screw which would have loosened it during normal use.Also the construction of the hinge joint pivot on the center bars were the screw has allegedly unscrewed from is such that no load is exerted on the screws which could create a turning moment as the side is operated.We have also tested the security of the thread cut into the plastic by the screw by performing a push out load on the end of the screw, no failure occurred.Close inspection of the wear patterns on the surfaces of the hinge moulding are consistent with the screw being secured correctly, we therefore can't find any reason for the screw to have been partially unscrewed out of the hinge moulding as shown in the photo provided by the community stores.Also the community store has not supplied any records of maintenance of the equipment.As the product is subject to wear and tear and to ensure that the device continues to perform within its original specification, we recommend in the product ifu (#746-396) chapter 8 maintenance: that preventive maintenance should be carried out annually.Under the heading, general: examine the bed for obvious signs of damage.All aspects of the equipment should operate as intended.Make sure that all nuts, bolts and other fastenings are tight and are not missing.The only conclusions as to why it was in this condition are: it was not fully screwed down in the first instance, however, this would seem unlikely for two reasons firstly it has been use for two and half years and secondly there were witness marks from the screw being fully screwed all the way in.Alternatively the screw has been partially unscrewed for reasons unknown by someone or it is some other undetermined root cause.We have reviewed our post market surveillance data on this safety side and others that use the same hinge moulding and fixing screw and we don't have any similar incidents of this nature that have been reported to us.On this particular model cm-acc06-1 folding safety side (pair) which was first put in to the market in 2004 and since that time we have sold a total of 10,700 pairs worldwide.In summary the device failed to meet specifications, was being used at the time of the event and therefore played a role n the event, causing a minor injury to a service user.However, the facility has not recorded the injuries.This failure is apparent to the users and they should take the appropriate action in accordance with the ifu and not use the accessory.Also taking this into consideration the (b)(4) therefore this incident appears to be isolated issue.Given the circumstances we shall continue to monitor for any further incidents of this nature, other than the actions already taken and we do not propose any further action at this time.
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