WRIGHTS LANE : SYNTHES USA PRODUCTS LLC 3.5MM CORTEX SCREW SELF-TAPPING 36MM; PLATE,FIXATION,BONE
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Model Number 204.836 |
Device Problems
Break (1069); Material Fragmentation (1261)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/01/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Patient information is unknown.Date of event is unknown.Additional classification code: hwc, jds.Explant date is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Therapy date of concomitant device is unknown.Without a lot number the device history records review could not be completed.The manufacture date is unknown.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 report that the patient had original surgery on (b)(6) 2017 for treatment of a distal tibial fracture.Patient was implanted with one (1) 3.5 mm- 8 hole anterior lateral distal tibial plate, one (1) 3.5 mm cortex self-tapping 36 mm screw, four (4) 2.7 mm cortex screws and one (1) unknown type screw that was implanted in the plate shaft.During the procedure, and after the surgeon had implanted all of the screws onto the plate for bone compression, he attempted to remove the previously implant 3.5 mm cortex self-tapping 36 mm screw.This screw position was implanted at the middle screw hole on the plate.While using a 2.5 mm drill bit to remove this screw and due to patient bone density the screw head broke off.The distal portion of the previously implanted screw remained in the patient¿s bone.Hospital has retained the broken screw head portion.Surgery was completed successfully with no time delay.Patient is reported in stable condition.Sales consultant has no more information to report on this event.Concomitant devices: unknown drill bit; (item number unknown, lot number unknown), quantity 1 each.This is report 1 of 1 for (b)(4).
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