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Catalog Number 657412S |
Device Problems
Flaked (1246); Material Fragmentation (1261)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/20/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Upon completion of the investigation, additional information will be provided in a supplemental report.
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Event Description
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While driving a bone screw into a distal fibula plate, metal wires(chips) came from the screw.No surgical delay or adverse consequences were reported.Procedure was completed successfully.
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Manufacturer Narrative
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Correction: section d4 (lot #).The reported event could be confirmed.Based on investigation, the root cause was attributed to be user related.The failure was caused by possible inadequate angulation during screw insertion.The device inspection revealed the following: some metal shaving (coils) on both returned screws is clearly evident.The metal coils are still attached to the screw bodies.The remaining coil on the screw with lot y44299 is thin, whereas the coil on lot y36493 is rather thick.Also the abrasions on both screws are almost for the entire length to the second last thread turn.Which indicates that the positioning of the plate and the predrilled hole were initially not line up accordingly and the applied angle during screw insertion resulted in the screw abrasions (coil).It looks as the plate was repositioned but still not enough in order to insert the second screw as there were still some thinner abrasions evident.Finally new screw(s) was inserted without any further problems (possibly after realigning the plate).A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.
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Event Description
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While driving a bone screw into a distal fibula plate, metal wires(chips) came from the screw.No surgical delay or adverse consequences were reported.Procedure was completed successfully.
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Search Alerts/Recalls
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