Model Number 209063 |
Device Problem
Failure to Calibrate (2440)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/09/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Stryker has initiated a voluntary, serial number specific recall for the mako integrated cutting system (mics) within scope of pfa.An updated communication will be forwarded upon completion of the internal investigation on this issue.Recall number will be provided once available.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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Angled blade will not pass on robot.If you physically move the blade to one end of the "sweep" it says it's off by 5 or 6mm.If you move it to the other end it passes.Tried multiple attachments and mics, and it still did this.Even got attachments from another facility to test.
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Manufacturer Narrative
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Reported issue: angled blade will not pass on robot.If you physically move the blade to one end of the "sweep" it says it's off by 5 or 6mm.If you move it to the other end it passes.Tried multiple attachments and mics and it still did this.Even got attachments from another facility to test.Case type / application: tka.Product inspection: the failure is confirmed as it is under the scope of nc: mics characterization process deviated from the qualified state.Also the serial number: (b)(6) lies in the urgent medical device recall list.Although the product was not received for evaluation.Device history review: review of the device history records indicate (b)(4) devices were manufactured under lot id: 42070420, and (b)(4) were accepted into final stock on 18 may 2020.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n: 209063, lot number: 42070420 shows 5 additional complaints related to the failure in this investigation.Conclusion: the failure is confirmed as it is under the scope of nc: mics characterization process deviated from the qualified state.Also the serial number: (b)(6) lies in the urgent medical device recall list.Although the product was not received for evaluation.No additional investigation or specific actions are required.H3 other text : device not returned.
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Event Description
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Angled blade will not pass on robot.If you physically move the blade to one end of the "sweep" it says it's off by 5 or 6mm.If you move it to the other end it passes.Tried multiple attachments and mics and it still did this.Even got attachments from another facility to test.
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Manufacturer Narrative
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Reported issue: angled blade will not pass on robot.If you physically move the blade to one end of the "sweep" it says it's off by 5 or 6mm.If you move it to the other end it passes.Tried multiple attachments and mics and it still did this.Even got attachments from another facility to test.Case type / application: tka.Product inspection: product was not inspected as the product was not returned for evaluation.Device history review: review of the device history records indicate 25 devices were manufactured under lot id 42070420, and 25 were accepted into final stock on 18 may 2020.No non-conformances were identified during inspection.Complaint history review: a review of complaints in catsweb and trackwise related to p/n 209063, lot number 42070420 shows no additional complaints related to the failure in this investigation.Conclusion: preventive maintenance is where an action occurs that identifies device deterioration which may compromise function.Under pm conditions no patient was involved and no actual or potential patient harm existed for the alleged event.The alleged failure mode could not be confirmed as the product was not available for inspection.No additional investigation or specific actions are required.Serial specific voluntary recall was initiated for the mako integrated cutting system (mics) within scope of a capa.The initial root cause analysis determined that the process for characterizing mics handpieces for specific serial numbers deviated from its qualified state at the time of validation.H3 other text : device not returned.
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Event Description
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Angled blade will not pass on robot.If you physically move the blade to one end of the "sweep" it says it's off by 5 or 6mm.If you move it to the other end it passes.Tried multiple attachments and mics and it still did this.Even got attachments from another facility to test.
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Search Alerts/Recalls
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