SMITH & NEPHEW, INC. STRAIGHT SCREWDRIVER; PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY
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Model Number 71362293 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/24/2020 |
Event Type
malfunction
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Event Description
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It was reported that two r3 screwdrivers tip are rounded off and will not engage properly.No delay or harm reported.The event was noticed outside a surgical environment since no case was involved.
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Manufacturer Narrative
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H3, h6: the devices, intended for use in treatment, were not returned for evaluation and the reported event could not be confirmed.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.The devices are reusable instruments that can be exposed to numerous surgeries; damage from repeated use can occur.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the devices or additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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