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Catalog Number 18060080S |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/17/2016 |
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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Pharmacist at the hospital, reported the following event : "during use, the guide was damaged in the tibia with the formation of metallic chips within it." no delay and no adverse consequences were reported by the customer.
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Manufacturer Narrative
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The evaluation revealed the guide wire to be the primary product.No deviations were found during review of the manufacturing and inspection documents (dhr).The wire returned was documented as faultless prior to distribution.During investigation no material, dimension, design or manufacturing related issues were found.The wire shaft was found heavily deformed approx.From the middle towards the tip.At the beginning of the deformation an im reamer abraded the shaft material and cut a deep track into the shaft; material got abraded and was buckled to burrs.Metal chips got stuck on the surface.Scratches on the surface behind the cut-damaged area indicate that the guide wire was used successfully with im reamers before.The abrasion of the shaft material was only possible because the guide wire was heavily deformed.The wire was used with reamers prior to the damage successfully.It is unclear whether the reamer was used in the same surgery or in previous surgeries multiple times.Deforming the wire is not intended and not necessary for reaming process, furthermore the wire is labeled as single use device.The ifu includes that modifying of the design of any instrument is not allowed, furthermore all instruments shall be checked prior every surgery.Single use items shall not be reused.Because no manufacturer related issues were found the case is attributed to the user (use error).Review of complaint history, capa databases and risk analysis did not identify any discrepancies.There are no open actions in place related to the reported event for the subject product(s).No non-conformity was identified.
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Event Description
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Pharmacist at the hospital, reported the following event: "during use, the guide was damaged in the tibia with the formation of mettalic chips within it." no delay and no adverse consequences were reported by the customer.
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Search Alerts/Recalls
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