Catalog Number 03.010.368 |
Device Problems
Break (1069); Material Fragmentation (1261)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/01/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.Patient information is not available for reporting.Device is an instrument and is not implanted/explanted.(b)(6).G5 510(k): device is not distributed in the united states, but is similar to device marketed in the usa.The subject device was received.The investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.A device history record review was performed for the subject device lot number.Manufacturing location: synthes (b)(4).Date of manufacture: feb 23, 2012.The review showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.No non-conformances were generated during the production of the subject device.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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Synthes (b)(4) reported an event in (b)(6) as follows: it was reported that during surgery to treat subtrochanteric femoral fractures on (b)(6) 2017 during the reaming step, the reamer broke approximately 25mm from the tip.The surgeon was able to retrieve the broken tip, implanted the nail again and resumed reaming.The surgeon commented that the nail got damage when the reamer interfered with the nail because there was no space to go for the reamer.He also said he should have stopped reaming.No fragments were retained in the patient and additional medical intervention was not needed.The surgery was delayed 60 minutes due to the reported event.The patient¿s postsurgical outcome is not available for reporting.This report is 1 of 1 for (b)(4).
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Manufacturer Narrative
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Product development investigation was completed.Device was received at manufacturer with the broken tip into two parts.The broken part was returned for investigation.The drill bit shows remarkable damage and wear on all cutting edges and the flutes.Because of the existing wear/damage only the three main diameters of drill bits cutting front could be checked for dimensions accuracy referred in technical drawing using caliper.The device dimensions met the specifications.The examination of the manufacturing papers and the (b)(4)-material testing certificate showed no deviations regarding dimensions, material analysis, strength and structural stability.The values were in compliance with ao/asif specification and with the international standards for stainless steel.The visual defect on the five year old reamer coincide and provide evidence that at the time of surgery the device may have been subjected to mechanical overloading.The reamers 03.010.368 are multiple use instruments hence the condition of the cutting blades before surgery are unknown.The leaflet with synthes instruments describes the recommended instrument inspections on reprocessing procedures before surgeries for reusable devices.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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