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Catalog Number 012014 |
Device Problems
Break (1069); Detachment Of Device Component (1104)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/12/2015 |
Event Type
malfunction
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Manufacturer Narrative
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Visual assessment confirmed the reported complaint of breakage.The upper jaw has broken from the shaft.The lug area of the upper jaw has also broken.Further examination using a stereo microscope confirmed that the cutting edge has been filed flat.A dull cutting edge such as this would require excessive forces to cut.Per the ifu "as with any surgical instrument, careful attention should be exercised to ensure that excessive force is not placed on the instrument.Excessive force can result in instrument failure.Do not use these instruments as levers for manipulating hard tissue or bone.Excessive force should not be applied to the instrument when manipulating soft tissue, bone, or hard objects.Misuse of these instruments may result in bent distal tips or jaws; and dull or uneven cutting edges".It has been determined that the device has been repaired in a manner inconsistent with current smith & nephew practice causing the reported failure.No root cause related to the manufacturing process can be established.No further investigation is warranted at this time.
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Event Description
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It was reported via a voluntary medwatch that during a procedure the entire jaw broke off and the jaw fell into the patient.The broken piece was retrieved by the surgeon and they are confident nothing was left in the patient.They were able to complete the procedure with a backup device.There were no patient complications reported as a result of this event.
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Search Alerts/Recalls
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