Catalog Number 309.006S |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Sedation (2368)
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Event Date 05/21/2014 |
Event Type
Injury
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Event Description
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Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported a surgeon was performing a revision surgery of a plate system, for an unknown reason and was unable to remove the screws due to damaged screw recess.The surgeon first attempted to use extraction screws, but was not successful.It was reported an extraction screw broke due to strong resistance, reported to be like a cold welding condition.Then a carbide drill bit was used, but the broken extract screw was not able to be removed.The surgeon decided to leave the plate and screw in the patient and closed the operation.It was reported this resulted in a surgical delay of 120 minutes.This is report 1 of 6 for (b)(4).
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Manufacturer Narrative
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Additional common device name; hwe.Device is an instrument and is not implanted/explanted.No nonconformance reports were generated during production.Review of the device history record showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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Additional narrative: a manufacturing evaluation was completed: our visual inspection has shown that the tip of the drill bit is blunt and worn out.These drill bits are single use devices and it is likely that the tip got blunt due to normal wear and tear.Lot 7728655 was manufactured in january 2011 to specification.No product fault could be found.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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