Model Number N/A |
Device Problem
Device Inoperable (1663)
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Patient Problem
No Patient Involvement (2645)
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Event Date 04/12/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Review of device history records show the lot released with no recorded anomaly or deviation.Current information is insufficient to permit a valid conclusion about the cause of this event; a follow-up report will be sent upon completion of the device evaluation.Report three of three for the same event, reference reports 0001032347-2017-00368 and 0001032347-2017-00369.
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Event Description
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It was reported four contra angled drivers that failed to function during a demonstration lab.One driver was sticking, two would not click into place, and one would not go into reverse.There is no surgery or patient involvement.
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Manufacturer Narrative
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The product identity was confirmed in the evaluation.The drivers were visually evaluated and looked to be in good condition.The drivers were functionally evaluated by inserting a screw into white oak with contra angle blade.Three of the four drivers were able to successfully seat a screw but exhibited rough rotation which is indicative of a bent drive shaft from excessive force.The driver that was not able to seat a screw was found to be stripped.It was disassembled and there was damage to the gear teeth and a bent drive shaft.The most likely cause of the broken drivers was determined to be excessive force.Instruction for use states: "avoid undue stress or strain when handling or cleaning instruments." this is supplemental report three of three for the same event.Reports one and two are reported on mfr #0001032347-2017-00368 and 0001032347-2017-00369.
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Search Alerts/Recalls
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