The locking screw (lot j08386) can¿t insert into pin hole during medical surgery.And then, the doctor tried to insert another two locking screws (lot j01439) into pin hole again on the outside of body.The locking screws always have issue to implant.Finally, the doctor used cortex screw instead of locking screw to finished surgery.
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The event could be confirmed, since the devices were returned for evaluation and they match the reported failure modes.The plate was received for inspection with a ¿locking screw axsos 4.0mm/l30mm¿, stuck in one of its holes.The plate, originally an 8-hole plate, is cut to a 3-hole (2 round threaded holes and one oblong hole.The surface of the plate is scratched with signs of usage.The oblong hole looks in a good condition, the threads of the first round hole are deformed, while a screw is stuck in the second round hole.The stuck screw has a scratched head and the threads just below the plate look deformed.An attempt to remove the screw from the hole was unsuccessful since the screw is indeed stuck.The inspection protocol was reviewed for both the plate and the stuck screw and did not indicate any deviations from the specifications.Therefore both devices were not delivered deformed, but became like that upon usage.It was reported that the screws were inserted manually after the drilling of the hole, no power tool was used, no torque limiter was used for the final insertion, and axial pressure was applied.Also, since the screws did not advance, the customer tried to push and turn them two times from different angles.A deviation from the instructions for proper usage of the devices could have definitely led to the reported stuck event.Please keep in mind that the instructions for proper use of the devices should be followed at all times.Consequently, the devices experienced an improper handling which led to the reported malfunction.Based on the investigation, the root cause was attributed to a user related issue.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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The locking screw (lot j08386) can¿t insert into pin hole during medical surgery.And then, the doctor tried to insert another two locking screws (lot j01439) into pin hole again on the outside of body.The locking screws always have issue to implant.Finally, the doctor used cortex screw instead of locking screw to finished surgery.
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