Catalog Number 50-20410 |
Device Problems
Break (1069); Detachment Of Device Component (1104)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 12/22/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The device has not yet been received at the manufacturer for testing.An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.
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Event Description
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It was reported by a company representative that during a surgical procedure the screw head broke off from the screw body when being torqued.The head part of the screw that broke off was recovered, and the remaining part of the screw body was left in the patient bone.The procedure was completed successfully without a delay.No medical intervention and no adverse consequences were reported with this event.
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Manufacturer Narrative
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The product was returned for investigation and the reported event could be confirmed.The investigation results show that the bone screw, cross-pin, 2.0xxmm broke as a result of too high torsional forces in forced rupture mode during the insertion.The chemical composition conforms to the specification ¿ tial6v4 (ti grade 5).The fracture surface shows the typical flow structures of a ductile torsional breakage.The root cause of the failure could have been (¿) a too low deepness of the pilot hole.Indications for material or manufacturing related problems were not found in this investigation.Therefore no corrective and/or preventive actions are deemed necessary at this time.
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Event Description
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It was reported by a company representative that during a surgical procedure the screw head broke off from the screw body when being torqued.The head part of the screw that broke off was recovered, and the remaining part of the screw body was left in the patient bone.The procedure was completed successfully without a delay.No medical intervention and no adverse consequences were reported with this event.
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Search Alerts/Recalls
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