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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 354965.(1) sample of 354965 lot g9 was received for evaluation.Due to the repetitive and isolated nature of the complaint the samples were reviewed in aggregate to better understand the root cause.Visual review of the samples noted that the samples represented a multiple states of failure.The broken jaws were examined under magnification and stress fractures and rust were noted on the broken surfaces.Several samples showed the jaw still attached with hairline cracks to partially detached.One sample in particular was physically bent behind the boxlock and the nature of the failure suggests tray damage was a factor.The stress fractures noted indicate that a oversized needle may have been used which was beyond the capacity of the device.Isolated and site specific.The samples provided indicate that tray damage and oversized needles may have played a role in the observed damage.(1) sample of 354965 lot g9 was received for evaluation.Due to the repetitive and isolated nature of the complaint the samples were reviewed in aggregate to better understand the root cause.Visual review of the samples noted that the samples represented a multiple states of failure.The broken jaws were examined under magnification and stress fractures and rust were noted on the broken surfaces.Several samples showed the jaw still attached with hairline cracks to partially detached.One sample in particular was physically bent behind the boxlock and the nature of the failure suggests tray damage was a factor.The stress fractures noted indicate that a oversized needle may have been used which was beyond the capacity of the device.A dimensional inspection was not required as part of this investigation.A functional inspection was not required as part of this investigation.Multiple complaints were implicated for the same product code from the same facility.Reference 20038603, 20038613, 20038642, 20038643, 20038644, 20038645, 20038646, 20038647 no confirmed complaints were received in this range with the same issue.Sap was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to 354965 isolated and site specific.The samples provided indicate that tray damage and oversized needles may have played a role in the observed damage.
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