Model Number SY149TS |
Device Problem
Device Damaged by Another Device (2915)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/06/2021 |
Event Type
Injury
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Manufacturer Narrative
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Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
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Event Description
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It was reported that there was an issue with sy149ts - ennovate polyax.Screw 7.5x80mm solid.According to the complaint description, the breakage of the ennovate screw was noticed when, after several attempts, they failed to apply the blockade.There was no described patient harm.Additional information was not available.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4).
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Manufacturer Narrative
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Updated information: updated patient harm to "additional medical intervention".B1: report type.B2: outcomes attribute to adverse event.B5: update.D9: device returned to manufacturer.Visual investigation: investigation was carried out visually and microscopically.A gap was found between the bottom of the head and the low side of the insert.The insert is loose.The thread of the head and the hexagon shows heavy wear and tear and deformation signs.It is not 100% clear whether the damage to the screw (loosened inlay) was caused by manufacturing or by usage error (levering in the hexagon during insertion).Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.The review of the risk assessment revealed that the overall risk level (severity 3(5) x probability of occurrence 2(5)) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.
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Event Description
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Update: an additional medical intervention was required.
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Search Alerts/Recalls
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