|
Model Number N/A |
Device Problem
Mechanical Jam (2983)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 06/19/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).Additional concomitant medical products: medical devices- hfn 130 deg 11mm x 180mm catalog#: 814511180 lot#: 901300, hfn 130 deg 11mm x 180mm catalog#: 814511180 lot#: 901380.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.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 multiple mdr reports were filed for this event, please see associated reports:0001825034-2018-04611, 0001825034-2018-04614.
|
|
Event Description
|
It was reported that during a hip fracture nailing procedure, while the operating surgeon was attempting to implant the lag screw, the set screw was unable to advance.The surgeon then had to remove everything and was still unable to move the set screw.Two (2) more nails were opened and tested, and these set screws also would not advance.The surgery was later successfully completed with a new nail.No additional patient consequences were reported.
|
|
Manufacturer Narrative
|
This follow-up report is being submitted to relay additional information.(b)(4).Complaint sample was evaluated and the reported event was confirmed.All three nails were returned and evaluated.The event of jammed set screws was confirmed.Dhr was reviewed and no discrepancies relevant to the reported event were found.Root cause was unable to be determined.Corrective action has been initiated to further address the event a summary of the investigation has been sent to the complainant.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.
|
|
Event Description
|
It was reported that during a hip fracture nailing procedure, while the operating surgeon was attempting to implant the lag screw, the set screw was unable to advance.The surgeon then had to remove everything and was still unable to move the set screw.Two (2) more nails were opened and tested, and these set screws also would not advance.The surgery was later successfully completed with a new nail.No additional patient consequences were reported.
|
|
Search Alerts/Recalls
|
|
|