|
Model Number BIO-COM-TENO SCW W/DIS DRV 4.75X15MM,VE1 |
Device Problems
Break (1069); Material Protrusion/Extrusion (2979)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/09/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that during an anterior cruciate ligament ankle surgery while the insertion of the biotenodesis screw 4.75 into the talar tunnel with the tendon graft held at the end of the device by the preassembled retaining wire.While the surgeon inserted the screw, the fiber wire holding the tendon graft at the end of the implant broke, causing the tendon graft to protrude out of the tunnel.Due to this failure the screw had to be removed in order to correctly reinsert the graft at the bottom of the tunnel with a new implanting device.The wire preassembled on the bio-tenodial screw was found to be broken on these 3 placements, making it impossible of introducing it at the bottom of the tunnel.As the screw itself was not damaged, it was not possible to add a grab wire to the device to hold the ligament graft and retry insertion of the graft into the talar tunnel.The surgeon assumed that the problem was caused by the breakage of the pre-mounted fibrous wire of the screw.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 is not confirmed.Upon visual evaluation, it was noted that the returned devices have no issues.However, the broken pieces were not returned for investigation, or photos provided for evaluation.No problem found.Functional testing noticed that the two drivers swivelock work as required.
|
|
Search Alerts/Recalls
|
|
|