Model Number 0580-355-0 |
Device Problem
Fracture (1260)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/25/2020 |
Event Type
malfunction
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
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Event Description
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It was reported that the trunnion broke off of the size 0 exeter rasp in patient and that it was not possible to reassemble rasp handle onto the rasp.
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Manufacturer Narrative
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Reported event: an event regarding crack/fracture involving exeter modular rasp sm cdh was reported.The event was confirmed based on inspection.Method & results: device evaluation and results: visual inspection: the device was returned in used condition and it can be observed that broach has been fractured at the notch.Ma: the broach was returned fractured at the notch.The device was examined with the aid of a stereo microscope at magnifications up to 50x.The fractured fragment was evaluated further using a scanning electron microscope (sem).The dimple and transgranular fracture morpholgies are consistent with an overload fracture.Energy dispersive spectroscopy analysis showed that the device was consistent with a 17-4 ph stainless steel (fe-cr-ni-cu) which is consistent with the drawing.Based on the given information no materials or manufacturing discrepancies were observed on the surfaces examined.Dimensional inspection: not performed as the dimensional aspects are not in question.Functional inspection: not performed as the functional aspects are not in question.Clinician review: no medical records were received for review with a clinical consultant device history review: all devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusion: it was reported that the trunion broke off of the size 0 exeter rasp in patient and that it was not possible to reassemble rasp handle onto the rasp.The event was confirmed based on inspection.Visual inspection: the device was returned in used condition and it can be observed that broach has been fractured at the notch.Ma: the broach was returned fractured at the notch.The device was examined with the aid of a stereo microscope at magnifications up to 50x.The fractured fragment was evaluated further using a scanning electron microscope (sem).The dimple and transgranular fracture morpholgies are consistent with an overload fracture.Energy dispersive spectroscopy analysis showed that the device was consistent with a 17-4 ph stainless steel (fe-cr-ni-cu) which is consistent with the drawing.Based on the given information no materials or manufacturing discrepancies were observed on the surfaces examined.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
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Event Description
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It was reported that the trunion broke off of the size 0 exeter rasp in patient and that it was not possible to reassemble rasp handle onto the rasp.
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Search Alerts/Recalls
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