It was reported that during an acl procedure, while opening the guide wire 1.2mm, there was a defect because the wire broke when the surgeon was trying to introduce the wire into the tibial tunnel, hence, a new guide wire 1.2mm was opened and used and the broken piece was removed from the patient.There was a surgical delay of less than 30 minutes and no further complications were reported.
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H10: internal complaint reference (b)(4).H3, h6: a device deficiency was not identified, and the root cause of the reported event could not be determined since the device was not returned for evaluation.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.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.Please refer to the instructions for use for precautions and warnings related to the use of the device.No containment or corrective actions are recommended at this time.
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