Catalog Number 254401017 |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 12/05/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Event Description
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Locking trigger has broken off impaction handle "this case has been reported by the loan kit technician during loan kit inspection.It has been forwarded to depuy engineering for assessment.No further information can be obtained as the case was not reported by the customer.
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Manufacturer Narrative
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(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Manufacturer Narrative
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Product complaint #: (b)(4).Investigation summary: conclusion and justification status: the complaint states locking trigger has broken off impaction handle the investigation confirmed that the lever had broken as reported.It should be noted that a field safety notice was issued stating that to reduce the possibility of leaving fragments in patients to adhere to the ifu which include inspecting the instruments to ensure that no instruments or pieces of instruments are left in the surgical site prior to closure.The complaint shall be closed with a justified conclusion; it will be entered into the complaint database and monitored through trend analysis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
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Search Alerts/Recalls
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