Model Number N/A |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Code Available (3191)
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Event Date 11/18/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).A review of the device history records show the lot released with no recorded anomaly or deviation.The warnings in the package insert state this type of event can occur.The user facility is foreign; therefore a facility medwatch report will not be available.It is reported the patient's bone density was very high.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.This is report one of two for the same event; report two of two is reported on mfr #0001032347-2016-00785.
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Event Description
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It was reported that during an aneurysm dissecting procedure for the body of the sternum, screws could not be completely inserted and had to be backed out by the surgeon.It is reported the surgeon tried using a manual driver after he couldn't insert the screws with the power driver.However, the screws still would not insert into the bone with the manual driver.It is reported the surgery was completed with less than a ten minute delay.It is reported that new screws of a smaller size were used in the same holes to complete the surgery.
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Manufacturer Narrative
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The product identities were confirmed through a picture provided by the distributor.Review of the picture reveals blood on the bent screws.This is consistent with the distributor's report that there were insertion attempts and the surgeon applied significant force to attempt to further insert the screws.Beyond the screws being bent, there does not appear to be any further damage on the screws' heads or threads.The distributor reported the screws were discarded.No product was returned and no functional tests could be performed; therefore the complaint could not be verified.The distributor stated the patient's bone density was very high.The most-likely underlying cause of this complaint is patient condition.There are no indications of manufacturing defects.This is report one of two for the same event.Report two of two is reported on mfr #: 0001032347-2016-00785-1.
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Search Alerts/Recalls
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