Catalog Number 703954S |
Device Problem
Flaked (1246)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/06/2015 |
Event Type
malfunction
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Event Description
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The customer, has reported via the sales rep.That during matta pelvic 2 surgery, metal flakes allegedly came off three kwires size 3.2x150mm (703954s).The sales rep has reported that the surgeon was using this kwire to hold the matta pelvic pro retractors.The sales rep has reported that the wound was washed out and that the surgery was completed as normal.
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Manufacturer Narrative
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Once the investigation has been completed any additional information will be reported in a supplemental report.
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Manufacturer Narrative
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The reported incident that k-wire ø3.2 x 150mm was alleged of following issue ¿metal flakes allegedly came off three k wires¿ could not be confirmed.Based on investigation, the root cause was attributed to a user related issue.The device inspection revealed the following: slight scratches on the surface of the k-wires.Metal flakes and major damages of the k-wires have not been identified.Scratches on the k-wire surface can be caused while inserting by a wrong angulation of the k-wire with the retractor.Rotation of the retractor over the inserted k-wires can lead to scratches and damages on the k-wire surface.Those damages can be prevented as described in operative technique (pro-st-1-en_rev-1_pro pelvis operative technique_2015-6912): ¿retractor 3: originally designed to retract the iliac vessels, retractor 3 is equipped with a light pipe attachment and 2 k-wires to hold the retractor in place and prevent rotation.Retractor 3 may be the most ideal for light pipe attachment.¿ a review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.
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Event Description
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The customer, has reported via the sales rep.That during matta pelvic 2 surgery, metal flakes allegedly came off three kwires size 3.2x150mm (703954s).The sales rep has reported that the surgeon was using this kwire to hold the matta pelvic pro retractors.The sales rep has reported that the wound was washed out and that the surgery was completed as normal.
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Search Alerts/Recalls
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