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Catalog Number 413.028 |
Device Problem
Peeled/Delaminated (1454)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/20/2014 |
Event Type
malfunction
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Manufacturer Narrative
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Additional narrative: a manufacturing evaluation was completed: the microscopic investigations of the complained locking screw manufactured in november 2013 shows that the threads on the locking head as well as the threads on the screw shaft were damaged during use.Because of the damage, the complaint relevant dimensions cannot be checked for dimensional accuracy of the valid manufacturing specifications.The anodized green color was abraded almost on the entire length.The flanks are rounded and worn.The review of the manufacturing documents showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.The condition of the returned device indicates that the screw came in contact with the plate during insertion or extraction while use.No product related condition was 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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Event Description
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Device report from synthes (b)(4) reports an event in (b)(6) as follows: it was reported that while inserting the 3.5 locking screws to philos, the paint of the screw was stripped and left a coil.The surgeon did irrigation for an additional thirty minutes.No patient harm was reported.This is report 1 of 2 for (b)(4).
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Manufacturer Narrative
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Device was not implanted/explanted.The investigation could not be completed; no conclusion could be drawn, as no product was received.No non-conformance reports 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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Search Alerts/Recalls
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