WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 12MM; PLATE, FIXATION, BONE
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Catalog Number 02.211.012 |
Device Problems
Break (1069); Entrapment of Device (1212)
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Patient Problem
Foreign Body In Patient (2687)
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Event Type
malfunction
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Manufacturer Narrative
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Product complaint #: (b)(4).Additional product code: hwc.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j representative.Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing 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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Event Description
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It was reported that on unknown date, the patient underwent a surgery for removal of hardware.During the surgery, it was noted that various small screws broke off on va distal humerus plates.These screws were too difficult to remove and have been left in patient bone.It is unknown if the surgery was successfully completed.It is unknown if there was a fragment generated.Patient status is unknown.Concomitant devices reported: unk - plates: lateral va-lcp proximal tibia plate(part# unknown, lot# unknown, qty unknown).This complaint involves five (5) devices.This report is for (1) 2.7mm va lckng screw slf-tpng with t8 stardrive recess 12mm.This report is 1 of 5 for (b)(4).
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Search Alerts/Recalls
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