BLUE BELT TECHNOLOGIES TIBIAL POLY IMPACTOR; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number 110014 |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/09/2015 |
Event Type
malfunction
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Event Description
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It was reported that the dr.Was impacting the poly into the patient and the tip of the polar impactor snapped off.The case was not delayed in anyway and the broken piece was never in the patient.
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Manufacturer Narrative
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H10 h3, h6: the device was used for treatment and the tip of the poly impactor snapped off.The device was not made available to the designated complaint unit for evaluation.Thus, visual and functional inspection could not be performed.Dhr review found that no conditions which could contribute to the reported event were identified.This information is reasonably suggesting that the device met the specifications at the date when it was released to the distribution.A complaint history found similar reports, this issue will continue to be monitored.We could not confirm if there was a relationship established between the reported event and the device.Photos of the device were not provided for evaluation and the device was not returned.Therefore, the root cause could not be determined.Factors that could have contributed to the event include mechanical component failure or the impactor not being able to withstand the impact stress applied by the surgeon.The tibial impactor design has since been updated to increase stiffness.
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Search Alerts/Recalls
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