Catalog Number UNK_JPR |
Device Problems
Break (1069); Metal Shedding Debris (1804)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 06/03/2015 |
Event Type
Injury
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Event Description
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It was reported by dr.(b)(6): "while the femoral tunnel it was preparing, when the flexible perforator broke.The perforator broke in the cannulated section where switches form rigid to flexible.Metal residues in the tunnel".
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Manufacturer Narrative
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Additional information will be provided once the investigation has been completed.Submitted by stryker endoscopy-(b)(4) as importer for device legally manufactured by (b)(4).
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Manufacturer Narrative
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An event regarding an versitomic acl flexible reamer, the event could not be confirmed as the device was scrapped or not returned.The legal manufacturer of the device could not perform an investigation without the physical device.As such the potential root cause of the failure could have been the following: potential misuse - as no additional event details were available through the legal manufacturer, thus potential root cause could not be ruled out.Potential product malfunction - as the product was not returned, thus potential root cause could no be ruled out.The product was not returned for investigation therefore the reported failure mode was not confirmed.The failure mode will be monitored for future reoccurrence.
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Event Description
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It was reported by dr.(b)(6): "while the femoral tunnel was preparing, flexible perforator broken.The perforator broken in the cannulated section where switches form rigid to flexible.Metal residues in the tunnel".
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Search Alerts/Recalls
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