Catalog Number 206270 |
Device Problems
Break (1069); Material Integrity Problem (2978)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/11/2018 |
Event Type
malfunction
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Manufacturer Narrative
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¿as part of 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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(b)(6) reported that "during mako total hip surgery, the doctor was installing acetabular cup prosthesis with inline offset impactor.The doctor decided that the cup was installed for and said he/she would blow with the mallet one last time.When the doctor hit impactor with the mallet as usual, back-end of the impactor broke.The doctor removed the impactor from the prosthesis in a typical manner, confirmed that the prosthesis was placed in the pelvis and carried the surgery on".
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Event Description
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(b)(6) reported that "during mako total hip surgery, the doctor was installing acetabular cup prosthesis with inline offset impactor.The doctor decided that the cup was installed for and said he/she would blow with the mallet one last time.When the doctor hit impactor with the mallet as usual, back-end of the impactor broke.The doctor removed the impactor from the prosthesis in a typical manner, confirmed that the prosthesis was placed in the pelvis and carried the surgery on".
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Manufacturer Narrative
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Product identification: the reported product is a shell impaction platform, p/n 206270, l/n 45010316 and rma 265328.Inspection: visual inspection shows the device fractured along the pin and button interface.See attachment.Product history: review of the device history records indicate 99 devices were manufactured and accepted into final stock on 07/19/2016.No non-conformances were identified during inspection.Complaint history review: review of complaints for p/n 206270, l/n 45010316 show no other complaints related to the alleged failure.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product non-conformity or unanticipated hazard.Conclusion: visual inspection shows the device fractured along the pin and button interface.Part inspection confirms reported issue.
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Search Alerts/Recalls
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