Catalog Number 209063 |
Device Problems
Migration or Expulsion of Device (1395); 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 09/21/2017 |
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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While resecting the distal femur, the collar on the mics hand piece became unattached due to a broken screw.We were able to switch hand pieces and re register and continue the surgery to completion.There was a 2 min delay just for changing the hand piece.Tka.
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Manufacturer Narrative
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Reported event: it was reported that the handpeice had a broken screw and fell apart.Issue was noticed during case, therefor there was a 2 minute case delay and no patient harm.Device history review: device history records indicate 25 devices were manufactured under lot k08cd and 23 including 4201095 were accepted into final stock on 9/21/16.A review of (b)(4) revealed that the issue is not related to the failure alleged in this compliant.Complaint history review: a review of complaints related to parts in lot number k08cd, p/n 209063 shows no other complaint related to the failure in this investigation."visual inspection: visual inspection revealed no physical damage of unit.Two screws backed out of the unit and a third screw broke.See attached pictures.Each of the backed out screws had evidence of loctite (as shown next to the part in the pictures).The broken screw had a fatigue fracture.Dimensional inspection: dimensional inspection was not completed visual inspection clearly shows the failure of the device.Functional inspection: the handpiece motor and electronics function as intended.Material analysis: material analysis was not completed because functional inspection clearly showed failure." conclusions: the screws hold the front end in place.If the screws back out then the front will come off.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated that (b)(4) and capa (b)(4) are associated with the failure mode reported in this event.
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Event Description
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While resecting the distal femur, the collar on the mics hand piece became unattached due to a broken screw.We were able to switch hand pieces and re register and continue the surgery to completion.There was a 2 min delay just for changing the hand piece.Tka.
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Search Alerts/Recalls
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