Catalog Number 111140 |
Device Problems
Crack (1135); Fracture (1260)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 02/27/2019 |
Event Type
malfunction
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Manufacturer Narrative
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A supplemental report will be submitted upon completion of the investigation.
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Event Description
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The tip of the slaphammer broke off at the screw threads.
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Manufacturer Narrative
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An event regarding crack/fracture involving a mako slaphammer was reported.The event was confirmed by photograph.Method & results product evaluation and results: the reported device was not returned however photographs were provided for review.The photographs note the following: the threaded tip has broken off the end of the slaphammer at the based of the threaded section.There is nothing else remarkable to note.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as the primary operative report and device return are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
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Event Description
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The tip of the slaphammer broke off at the screw threads.
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Search Alerts/Recalls
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