WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 22MM; SCREW, FIXATION, BONE
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Model Number 02.211.022 |
Device Problems
Fitting Problem (2183); Device Damaged by Another Device (2915); Device-Device Incompatibility (2919)
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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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Patient dob & weight is not available for reporting.Date of event is unknown.Additional product code: hrs.Not implanted or explanted, partial device remained in patient.Complainant device is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.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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It was reported that on an unknown date, the variable angle (va) self tapping locking screw went through the va locking compression plate (lcp) posterolateral distal humerus plate.The surgeon was using the va elbow system.The case was going fine until the last screw placement into the plate.The surgeon pre-drilled with a drill bit on a nominal angle.The surgeon powered the locking screw down, and stopped short of the plate and went to tighten by hand and the screw went directly through plate countersinking into the bone.The screw was not into the joint so the surgeon decided to leave the screw implanted in the bone.No action was done due to it would require taking all of the screws and the plate off and starting over.If the screw migrates into the joint, the patient would have to come back for a revision.It is unknown if there was a surgical delay.Patient and surgical outcome is unknown.Concomitant device reported: drill / drill bit (part# 323.062 lot# unknown, quantity# 1).This complaint involves one (1) device, - variable angle (va) self tapping locking screw.This report is 1 of 2 for (b)(4).
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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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