Catalog Number 13200330 |
Device Problem
Break (1069)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 10/12/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Once the investigation has been completed any additional information will be reported in a supplemental report.
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Event Description
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Attempted to turn left the u lag screw connector by the t handle after inserted the u blade.The u lag screw connector was broken, it was turned manually and removed the u lag screw connector.
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Manufacturer Narrative
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Event description indicates the u-blade lag screw connector to be the primary product.No further associated products are reported.Deviations in the device history records / inspection records were not found.Mechanical properties of material and dimensions in the relevant undamaged areas are within specified tolerances.The u-blade lag screw connector returned was documented as faultless prior to distribution, and as it had been in use for at least seven years, we pre-suppose that it had fulfilled its tasks in former surgeries as intended without problems reported.Appearance of the breakage surfaces in combination with slightly oblique fracture line indicates that the device broke in a forced brittle manner due to disproportional force and/or bending stresses by levering the instrument.Evaluation revealed evidence that the event is not linked to a deficiency of the device but is rather related to improper handling.Review of complaint history, capa databases and risk analysis did not identify any conspicuity.The review of the risk assessment for the failure mode indicated the issue was addressed adequately.There are no actions in place related to the reported event for the subject product.No non-conformity was identified.
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Event Description
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Attempted to turn left the u lag screw connector by the t handle after inserted the u blade.The u lag screw connector was broken, it was turned manually and removed the u lag screw connector.
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Search Alerts/Recalls
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