Catalog Number 201.932 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/04/2017 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Device broke intra-operatively and was not implanted/explanted.Without a lot number the device history records review could not be completed.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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 europe reports an event in (b)(6) as follows: it was reported that during a surgery, two imf screws broke.This is report 1 of 2 for (b)(4).
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Manufacturer Narrative
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Product development investigation was completed; the report indicates that: we have received two imf screws for investigation.The visual inspection of both screws has shown that both tips are broken off.The broken off parts were not returned for evaluation.The microscopic investigation has shown damages on the cross slot.Unfortunately we are not able to determine the exact cause which has led to this occurrence, due to the damages on the cross slot we can only assume that a mechanical overload situation has led to the breakage.The device history record could not be reviewed, as the lot numbers of both articles are unknown.Because of the damage, the complaint relevant dimensions cannot be checked for dimensional accuracy of the valid manufacturing specifications 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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