BLUE BELT TECHNOLOGIES STRIDE FEMORAL INS/REM IMPACTOR HEAD; PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
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Catalog Number PFSR100931 |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/18/2016 |
Event Type
malfunction
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Event Description
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It was reported that the femoral impactor is split in two pieces.Since the allegation was noticed in the sterilisation center, no case was being carried out; therefore, no patient was involved at the time of the finding.
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Manufacturer Narrative
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H10 h3, h6: the device was intended for use in treatment.The device was not made available to the designated complaint unit for investigation.Thus, functional inspection could not be performed.A photo was returned for visual inspection, which confirmed that the femoral impactor head had broken into two pieces.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.We could confirm if there was a relationship established between the reported event and the device.The malfunction is most probably due to a mechanical component failure of the femoral impactor head breaking during use/impaction.
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Search Alerts/Recalls
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