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Catalog Number 03.037.010 |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/09/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Patient identifier, date of birth and weight are not available for reporting.Device is an instrument and is not implanted/explanted.A review of the device history records has been requested.The device has been received and the product evaluation is in progress.No conclusion can be drawn.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 three devices malfunctioned during a trochanteric fixation nail-advanced insertion procedure on (b)(6) 2017.The connecting screw that goes through the insertion handle could not be loosened; therefore, the tip of the screwdriver broke off in two pieces when attempting to loosen the connecting screw.The tip of the screwdriver was retrieved with no additional medical intervention.At that point, the implants (nail and lag screw) and instruments were removed from the patient and new implants and instrument sets were opened.There was a 10 to 15 minute delay to obtain and open the new sets.The lag screw was re-used in the patient; a new synthes nail was used as the threads of the nail were damaged when trying to remove it.The surgery was successfully completed and the surgeon was satisfied with the patient outcome.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: november 26, 2015.No non-conformance reports were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A product investigation was completed: a visual inspection, drawing review, and dhr review were performed as part of this investigation.This complaint is not likely a result of any design or manufacturing related deficiency.Per the technique guide, the 03.010.517 t-handle ball hex screwdriver and 03.037.010 cannulated connecting screw are instruments routinely used in the tfn advanced proximal femoral nailing system.The complaint for part 03.010.517 (t-handle screwdriver) was confirmed as the device was missing a broken tip.The ball hex tip of the driver appears to have sheared off the device and was not returned.It is likely that over 3.5 years of consistent use and possible rough handling during surgery or sterile processing has led to this complaint condition.The returned t-handle shaft looks bent and otherwise is in good condition without much visible wear.The complaints for parts 03.037.010 (connecting screw) and 04.037.456 (tfna nail) could not be confirmed.The features relevant to the complaint (distal threads of connecting screw and proximal threads of tfna nail) show no sign of pre or post manufacturing defect.No excessive force was required to screw or un-screw above two devices during functionality test.The relevant drawings were reviewed during this investigation.No product design issues or discrepancies were observed.The returned part was determined to be suitable for the intended use when employed and maintained as recommended.It has been noted that soft tissue pressure can lead to a jamming of the devices.The technique guide has been updated to provide additional guidance for when the connecting screw is difficult to remove.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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Concomitant devices reported: lag screw (part # unknown, lot # unknown, quantity 1), complete radiolucent insertion handle (part # 03.037.012, lot # 8346783, quantity 1).
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Search Alerts/Recalls
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