ARTHROCARE CORP. ULTRABUTTON ADJUSTABLE FIXATION DEVICE; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
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Model Number 72290003 |
Device Problems
Break (1069); Difficult to Fold, Unfold or Collapse (1254)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/19/2021 |
Event Type
Injury
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Manufacturer Narrative
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Internal complaint reference: (b)(4).
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Event Description
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It was reported that, during acl reconstruction surgery, the tendon graft was mounted with the "ultrabutton adjustable fixation device", the plate was raised to the cortex of the green sutures until anchoring in the bone (femoral).After the loop anchoring, the graft was raised, but at a certain point the graft did not rise anymore, leaving a large part of the graft outside and hanging (tibial); everything was done according to the surgical technique of the product.A 2nd "ultrabutton adjustable fixation device" of the same reference was used and at the moment of pulling the sutures, they broke without using excessive force and without being able to raise the graft sufficiently.The two products were removed successfully from the patient.The procedure was finally completed changing the surgical technique using a 3rd "ultrabutton adjustable fixation device".A screw-screw technique was used since tenosuspension was not possible and with this change in technique it worked.The case was delayed greater than 30min and no damage was caused.The patient's health condition is stable.
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Event Description
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It was reported that, during acl reconstruction surgery, the tendon graft was mounted with the "ultrabutton adjustable fixation device", and the plate was raised to the cortex of the green sutures until anchoring in the bone (femoral).Then, after the loop anchoring, the graft was raised, but at a certain point the graft did not rise anymore, leaving a large part of the graft outside and hanging (tibial); everything was done according to the surgical technique of the product.In consequence, the device was removed successfully without novelty.A 2nd "ultrabutton adjustable fixation device" of the same reference was used, but at the moment of pulling the sutures, they broke without using excessive force and without being able to raise the graft sufficiently.As a result, this device also had to be removed from the patient.For this, the doctor cut the sutures in their entirety and due to a movement the doctor had to make to remove the material adhered to the bone, the device came out in its entirety.Finally, the procedure was completed using a 3rd "ultrabutton adjustable fixation device" by changing the surgical technique.A screw-screw technique was used since tenosuspension was not possible and it worked.The case was delayed greater than 30min and no damage was caused.The patient's health condition is stable.
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Manufacturer Narrative
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B1, b2, b5, d4, h1: updated.
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Manufacturer Narrative
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H10: h3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the raw material found that during quality conformance specifications verification that the coc report complies with: usp diameter 0.0276¿ minimum / 0.0315¿ maximum, usp knot-pull tensile strength = 17 lbf, and each straight pull braid strength = 39 lbf is performed and in additional certificate of conformity required for each shipment.There was no relationship found between the device and the reported event.The complaint was not confirmed.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
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Manufacturer Narrative
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H10: h3, h6: part of the device, used in treatment, was received for evaluation.A visual evaluation showed that an original box with the batch number of the complaint on the label was returned.There was no device inside.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specifications upon release for distribution.A complaint history review found similar reported events.The instructions for use were reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the raw material found that during quality conformance specifications verification that the coc report complies with the usp knot-pull tensile strength and pull braid strength requirements.A certificate of conformity is required for each shipment.The root cause could not be determined since the reported malfunction could not be duplicated during the investigation.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.
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