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Model Number 72204046 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/15/2020 |
Event Type
Injury
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Event Description
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It was reported that during an all inside acl, it was found that the 2.4mm drill wire included in the trunav set was defective.The laser marking at the tip of the drill was missing.When positioned the drill approximately as it should have been with laser marking and when the acufex was moved in the gauge over the wire from the outside, the gauge showed a femoral tunnel length of 65mm, which was considered very unlikely and it was necessary to used alternative measurement methods.The procedure was completed without significant delay using a back-up device.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
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Manufacturer Narrative
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The reported 72204046 10mm retrograde drill, intended for use in treatment, has not been returned for evaluation.Without the reported product a visual or functional evaluation cannot be performed and the customers complaint cannot be confirmed.From the information provided, ¿during an all inside acl, it was found that the 2.4mm drill wire included in the trunav set was defective.The laser marking at the tip of the drill was missing.When positioned the drill approximately as it should have been with laser marking and when the acufex was moved in the gauge over the wire from the outside, the gauge showed a femoral tunnel length of 65mm, which was considered very unlikely and it was necessary to used alternative measurement methods¿.Images were provided by customer.An exact root cause cannot be determined with confidence viewing the image.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.Risk management record was performed for the reported device.A review of the complaint and manufacturing records was performed and indicated similar allegations for the lot number reported.
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Search Alerts/Recalls
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