Model Number ACL TIGHTROPE RT |
Device Problem
Material Split, Cut or Torn (4008)
|
Patient Problem
Insufficient Information (4580)
|
Event Date 11/17/2021 |
Event Type
malfunction
|
Event Description
|
It was reported that during an anterior cruciate ligament knee surgery the tightrope tore when the strap was pulled in.The surgeon reported that there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
|
|
Manufacturer Narrative
|
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
|
|
Event Description
|
It was reported that during an anterior cruciate ligament knee surgery the tightrope tore when the strap was pulled in.The surgeon reported that there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.
|
|
Manufacturer Narrative
|
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
|
|
Manufacturer Narrative
|
Complaint allegation was confirmed.Visual inspection identified that the blue suture construct had broken.One end had the suture frayed.Other section of the suture was not returned.No damaged was observed at the white suture or loop, as well to the button.The cause of this event is undetermined; however, most possible cause is user applied mechanical forces or contact with sharp objects during use, leading to the breakage observed during inspection.
|
|
Search Alerts/Recalls
|