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Catalog Number 03.010.061 |
Device Problem
Material Integrity Problem (2978)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/06/2015 |
Event Type
malfunction
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Manufacturer Narrative
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Device is an instrument and is not implanted/explanted.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.Dhr review ¿ manufacturing location: (b)(4).Manufacturing date: 07.Sep.2011.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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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Event Description
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Device report from synthes (b)(4) reports an event in (b)(6) as follows: during surgery, two (2) 4.2 mm and two (2) 5 mm drill bits were used, however they were not sharp thus taking longer to drill through the bone.The surgery was reportedly extended for a few minutes.There is currently no additional information.This is report 2 of 4 for (b)(4).
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Manufacturer Narrative
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(b)(6).Device investigation summary ¿ the drill bits were analyzed for conformance to print specifications as well as the device history records were reviewed; no abnormal findings were identified.Manufacturing and inspection records indicated no problems with the lot in question (manufactured in the year 2011).Further investigation has shown that the cutting edges have heavy traces of wear.Since no manufacturing related condition was found, it is likely that normal wear and tear during frequent use.It is noted; blunt drill bits require more mechanical power during the application, therefore it is recommend that blunt or damaged instruments need to be exchanged before surgery.No product fault could be detected.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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