Model Number 25-092-12-91 |
Device Problem
Break (1069)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 06/28/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4) is submitting this report on behalf of karl leibinger medizintechnik gmbh & co.Kg (manufacturer).Reference exemption number (b)(4).Multiple mdr report were filed for this event, please see associated report: mdr 9610905-2018-00140.
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Event Description
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It was reported while placing the mmf screw the head broke off.
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Manufacturer Narrative
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An investigation was performed using a stereo microscope which revealed tensile cracks.Further observation determined there were no indications of material or manufacturing defects.The complaint percentage was calculated, and it is determined that the complaint percentage falls within the design risk limits adhered to at klm.A review of the device history records was not possible due to no lot number identified.The investigation results conclude that the root cause for breakages were due to structural failure of the device due to mechanical overload.If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.
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Search Alerts/Recalls
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