Model Number 209063 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 11/07/2019 |
Event Type
malfunction
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Manufacturer Narrative
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As part of the normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.
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Event Description
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Handle keeps falling off.Case type: tka.Update: mps response "the screw in the bottom of the device was loose, so it fell off with the grey handle.But it was found and cleaned for return with the mics.".
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Event Description
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Handle keeps falling off.Case type: tka.Update: mps response "the screw in the bottom of the device was loose, so it fell off with the grey handle.But it was found and cleaned for return with the mics".
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Manufacturer Narrative
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Handle keeps falling off.Case type: tka.Update: mps response "the screw in the bottom of the device was loose, so it fell off with the grey handle.But it was found and cleaned for return with the mics".Product inspection.As per service maxwo-02199654 & case number (b)(4).Mics-209063 sn#(b)(6) lot#42060519 rma#284279 senior depot service technician: (b)(6).1.Successfully performed mics cable replacement per d06917.Mics can be returned to stock as a 209063 sn#(b)(6).The alleged failure was not confirmed.Device history review.Device history records indicate (b)(4) devices were manufactured under lot k0cwf and (b)(4) devices were accepted into final stock on 05-29-2019.Complaint history review.A review of complaints in catsweb and trackwise related to p/n 209063, lot number 42060519 shows no additional complaints related to the failure in this investigation.Conclusion.The device failure mode identified during inspection is not consistent with the reported issue.No additional investigation or specific actions are required.
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Search Alerts/Recalls
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