Catalog Number PLSL3518S |
Device Problem
Metal Shedding Debris (1804)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 06/21/2017 |
Event Type
malfunction
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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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Event Description
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The surgeon reported that she was inserting a 3.5mm screw into an anchorage foot plate and that during tightening, a small shaving of metal came off the screw.The shaving fell onto the bone and was immediately retrieved using forceps.The surgeon attempted to implant 2 further screws and these also appeared to be too big for the plate.Surgery was completed using a 3.00mm screw instead.There was a 5 minute delay to surgery.
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Manufacturer Narrative
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The reported event that locking screw anchorage ø3.5mm / l16mm was alleged of 'breakage during surgery' (metal wire came off the screw thread) could be confirmed.The device inspection revealed that the thread of the screw is damaged: a thin part of the edge was removed.Based on investigation, the root cause was attributed to be user related.The wire most likely came off because the user inserted the screw in a wrong position.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.The instruction for use (v15095 rev b anchorage non sterile ((b)(4)) was reviewed and found to be complete.
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Event Description
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The surgeon reported that she was inserting a 3.5mm screw into an anchorage foot plate and that during tightening, a small shaving of metal came off the screw.The shaving fell onto the bone and was immediately retrieved using forceps.The surgeon attempted to implant 2 further screws and these also appeared to be too big for the plate.Surgery was completed using a 3.00mm screw instead.There was a 5 minute delay to surgery.
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Search Alerts/Recalls
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