Catalog Number 201.932E |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/12/2015 |
Event Type
malfunction
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.Without a lot number the device history records review could not be completed.The subject device has been received and is currently in the evaluation process.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 two (2) intermaxillary fixation (imf) screws broke during surgery.The surgery was performed to repair a fractured mandible in male patient.The delay to the case was less than one minute as the surgeon implanted four additional imf screws, part number 201.932e.This report is 2 of 2 for (b)(4).
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Manufacturer Narrative
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Device investigation summary ¿ the following device(s) were received: 2.0mm imf screw (part # 201.9xx | lot # unknown) quantity: 2.Both screws were returned with the tips broken off.The tips of both screws were not returned.The other parts of the screws are in good condition with no other observable damage.It is unknown what caused the complaint condition, but it is possible that the screws were being inserted into dense cortical bone without first pre-drilling.During the investigation no product design issues or discrepancies were observed that may have contributed to the complaint condition.A visual inspection and drawing review were performed as part of this investigation.No product design issues or discrepancies were observed.This complaint is confirmed.Device drawings for the device(s) were reviewed.No drawing issues or discrepancies were noted.The design was determined to be suitable for the intended use when employed and maintained as recommended.Proper use and maintenance for the device(s) are addressed in the technique guide for the imf screw set.It is recommended that the surgeon pre-drill the hole for the imf screws when inserting into dense cortical bone.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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