Medical product- compress 5cm taper adapter catalog#178711 lot# ni, compress oss locking cap and screw catalog# 178710 lot# ni, compress ha anti-rotation spindle small 38mm 800lbf porous coat catalog# 178355 lot# ni, compress segmental anchor plug 14mm catalog# 178404 lot# ni, compress finn nut catalog# 178512 lot# ni, compress finn transverse pin size 36mm catalog# 178528 lot# ni, compress transverse pin ti 40m m catalog# 178529 lot# ni, compress finn transverse pin size 48mm catalog# 178531 lot# ni, compress short anchor plug 10mm catalog# 178552 lot# ni, cps short anchor plug 14mm catalog# 178556 lot# ni.This report is number 2 of 10 mdrs filed for the same patient (reference 0001825034 - 2017 - 00779 , 0001825034 - 2017 - 00782, 0001825034 - 2017 - 00791, 0001825034 - 2017 - 00794, 0001825034 - 2017 - 00795, 0001825034 - 2017 - 00797, 0001825034 - 2017 - 00802, 0001825034 - 2017 - 00803, 0001825034 - 2017 - 00804, 0001825034 - 2017 - 00868).
|
This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was confirmed.Dhr review was unable to be performed as the lot number of the device involved in the event is unknown.A process review revealed that the appropriate contents were included in the kit and procedure was followed by the manufacturer in communicating said contents to the distributorship; however, the kit documentation completed by the distributorship on the outside of the container did not indicate accurate contents.Review of complaint history determined that no further action is required as no trends were identified.Investigation results concluded that the reported event was due to a labeling problem by the distributorship.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
|