WRIGHTS LANE SYNTHES USA PRODUCTS LLC VA LOCKSCR Ø2.7 HEAD 2.4 SELF-TAP L20 TA; SCREW,FIXATION,BONE
|
Back to Search Results |
|
Model Number 04.211.020 |
Device Problems
Break (1069); Unintended Movement (3026)
|
Patient Problem
Failure of Implant (1924)
|
Event Type
Injury
|
Manufacturer Narrative
|
Patient information is unknown.Date of event is unknown.Additional classification code: hrs.Complainant part is not expected to be returned for manufacturer review/investigation.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.
|
|
Event Description
|
It was reported that patient underwent an open reduction internal fixation (orif) of distal humerus with perpendicular plating using titanium va elbow system with medial plate and posterolateral plate on (b)(6) 2018.One month after surgery, x-ray was done and appeared to indicate possibility that one or more distal screws of posterolateral plate had backed out from plate along with a loss of reduction.On (b)(6) 2018, revision was performed and revealed that the locking screw and metaphyseal screw were backed out.Upon screw removal, the locking screw was found to be broken at junction of head element and shaft with an estimated broken length of 20 as checked by a surgical technician.Other screws removed from posterolateral plate were intact with no noted abnormalities.Posterolateral plate removed intact with no apparent abnormalities noted by customer.Medial plate and screws from the implantation surgery was left in place.There was an unknown surgical delay.There was an unknown patient outcome.No additional information provided.Concomitant device reported: unknown medial plate (part number unknown, lot number unknown, quantity 1); unknown posterolateral plate(part# unknown, lot# unknown, quantity 1).This is report 1 of 2 for (b)(4).
|
|
Event Description
|
It was reported that patient underwent an open reduction internal fixation (orif) of distal humerus with perpendicular plating using titanium va elbow system with medial plate and posterolateral plate on (b)(6) 2018.One month after surgery, x-ray was done and appeared to indicate possibility that one or more distal screws of posterolateral plate had backed out from plate along with a loss of reduction.On (b)(6) 2018, revision was performed and revealed that the locking screw and metaphyseal screw were backed out.Upon screw removal, the locking screw was found to be broken at junction of head element and shaft with an estimated broken length of 20 as checked by a surgical technician.Other screws removed from posterolateral plate were intact with no noted abnormalities.Posterolateral plate removed intact with no apparent abnormalities noted by customer.Medial plate and screws from the implantation surgery was left in place.There was no surgical delay reported.Revision surgery was successfully completed.There was an unknown patient outcome.Concomitant device reported: unknown medial plate (part number unknown, lot number unknown, quantity 1) unknown posterolateral plate(part# unknown, lot# unknown, quantity 1).
|
|
Manufacturer Narrative
|
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.
|
|
Search Alerts/Recalls
|
|
|