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Qn# (b)(4).Device history record was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to 354964.(1) sample of 354964 lot f7 was received for evaluation.Visual review of the sample noted that the tungsten carbide jaws of the device were completely worn away at the tips.The wear pattern suggests that there has been needle rolling and torquing of the jaws consistent with an oversized needle.This device has been used for many years and the worn jaws likely allowed for a larger needle without breaking the jaws at the pivot point as was evident in the (10) additional complaints from this cusotmer.The device is functional with the exception of the worn jaws.Isolated and site specific.The samples provided include multiple lots and product codes which indicates that tray damage and oversized needles may have played a role in the observed damage.(1) sample of 354964 lot f7 was received for evaluation.Visual review of the sample noted that the tungsten carbide jaws of the device were completely worn away at the tips.The wear pattern suggests that there has been needle rolling and torquing of the jaws consistent with an oversized needle.This device has been used for many years and the worn jaws likely allowed for a larger needle without breaking the jaws at the pivot point as was evident in the (10) additional complaints from this cusotmer.A dimensional inspection was not required as part of this investigation.A functional inspection was not required as part of this investigation.Sap was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to 354964 related complaints include 20038589, 20038680, 20038604 and 20038603, 20038613, 20038642, 20038643, 20038644, 20038645, 20038646, 20038647 from a similar device.Isolated and site specific.The samples provided include multiple lots and product codes which indicates that tray damage and oversized needles may have played a role in the observed damage.From the samples received it would appear that this was the original device which was being used and wore out.The worn jaw left a gap which allowed for a larger needle to be used without overstressing the pivot point.When the inserts wore down to a flat needle security was lost.The other 10 complaints appear to have been used in a similar manner but fractured at the pivot point when used due to the unworn jaws.
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