Catalog Number 04.503.236.01S |
Device Problem
Material Separation (1562)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/24/2014 |
Event Type
malfunction
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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 the surgeon implanted screws and when he tried to remove them from the plate to readjust the plate, the head of the screw snapped off both of the screws.No adverse outcome to the patient was reported.An additional three to five minutes was added to the surgery due to this event.This report is for 1 screw.This is report 2 of 2 for (b)(4).
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.Additional common device name jey.The investigation could not be completed; no conclusion could be drawn, as the product is entering the complaint system.Without a lot number the device history records review could not be completed.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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(b)(4): a review of the device history records was completed for both lot numbers: no non-conformance reports were generated during production.Review of the device history records showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A manufacturing evaluation was completed: our investigation shows that two screws were sent back.The screw, article 04.503.205.04s, is worn out at the screw recess.Only a screw recess fragment of article 04.503.236 is available.The broken part is missing.The manufacturing review shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.Based on the received information we can not determine the exact root cause.It is likely that exceeding applied torsional force while use (with a possible damaged screwdriver) has lead to these damages.Unfortunately the screwdriver itself was not returned for investigation.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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