OBERDORF : SYNTHES PRODUKTIONS GMBH 2.0MM SPADE-POINT REDUCTION WIRE 400MM; APPLIANCE,FIXATION,NAIL
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Catalog Number 292.410 |
Device Problem
Bent (1059)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/06/2017 |
Event Type
malfunction
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Manufacturer Narrative
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No patient involvement was reported.Additional product code: lxt.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.(b)(6).Subject device has been received and is currently in the evaluation process.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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It was reported that during an inventory check before the surgery, it was found that the wire had been bent entirely.In addition, a piece of the plastic material had been attached to the tip of the wire.The complaint device was never used to the patient.This is report 1 of 1 for (b)(4).
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Manufacturer Narrative
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Manufacturing location: (b)(4).Manufacturing date: may 23, 2011.No non-conformance reports were generated during production.Review of the device history record (dhr) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A product investigation was completed: upon visual inspection of the complaint device it can be seen that wire is slightly bent as reported, this thus confirming the complaint description.Furthermore we have received the part with an open packaging.Dhr review showed no issues.During investigation the diameter was measured with the micrometer; the measure result is within specification.As the packaging is already opened up, we unfortunately aren¿t able to determine the exact reason for this reported problem.Furthermore as the packaging was open we are not able to determine where the piece of plastic is coming from.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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