Catalog Number 14-533041 |
Device Problem
Material Disintegration (1177)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Type
Injury
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Manufacturer Narrative
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Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Reference report number 3012447612-2018-00198.The subject inserter and shaft were used in three procedures within the same hospital with the same outcome prior to manufacturer notification.The inserter is the subject of reports 3012447612-2018-00152, 3012447612-2018-00198, and 3012447612-2018-00200.The shaft is the subject of reports 3012447612-2018-00153, 3012447612-2018-00199, and 3012447612-2018-00201.
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Event Description
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It was reported that it appeared that metal debris was generated as the surgeon was using a mallet to impact the inserter sleeve and shaft to install an implant into the disc space.The surgeon felt that it is possible that the patient may have retained some of the debris.The sleeve and shaft were used to complete the procedure without additional reported patient impacts.This is report two of two for this event.
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Manufacturer Narrative
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Additional information in: lot number.Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
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Manufacturer Narrative
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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.
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Manufacturer Narrative
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The returned shaft was evaluated.The event was recreated during bench top testing and debris was seen from the area surrounding the knob that slides over the end of the shaft during impaction.The device was disassembled and there were drag marks seen of the surfaces which slide against one another between the knob and shaft end.The cause is attributed to wear from repetitive use.Similar items from other lots were also tested in the same manner, and did not exhibit the same type of debris generation.Therefore, this is believed to be an isolated occurrence.A review of the dhr did not identify any issues which would have contributed to this event.
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Search Alerts/Recalls
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