OBERDORF SYNTHES PRODUKTIONS GMBH 2.4MM TI HDLSS COMPRESSION SCR 20MM/LONG THREAD-STERILE; SCREW,FIXATION,BONE
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Catalog Number 04.226.320S |
Device Problems
Failure to Cut (2587); Difficult to Advance (2920)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.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 reports an event in (b)(6) as follows: it was reported that on an unknown date, during an unknown procedure, the 2.4 mm headless compression screw and unknown 3.0 mm headless compression screw cannot be inserted.When the surgeon tried to insert the screws into the bone, it was hard to advance them.The surgeon felt that self-drilling function of the screws was worse than that of another company¿s headless compression screws.Hence, the surgeon requested to improve the design of the hcs so that self-drilling function will be improved.The surgery was completed successfully though it is unknown how was the surgery completed.Patient and procedure outcome were unknown.This report is for one (1) 2.4mm ti hdlss compression scr 20mm/long thread-sterile.This is report 1 of 2 for (b)(4).
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Search Alerts/Recalls
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