Model Number 199721745 |
Device Problem
Material Split, Cut or Torn (4008)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/26/2019 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The device is available for evaluation.Investigation will be conducted.Follow up will be filed with the investigation results.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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It was reported that on (b)(6) 2019, during insertion of the innie, the innie did not align properly and positioned itself into a displaced part of screws´s thread.There was no surgical delay and there was no patient consequence.This complaint involves four (4) devices.
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Manufacturer Narrative
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Product complaint # = > (b)(4)., h4.
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Manufacturer Narrative
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Product complaint # = > (b)(4).Udi: (b)(4).Visual examination of the returned device found the extended tabs with loading zone were returned separately from the device.Upon visual inspection, it was observed that the drive feature between the hypermobile head and the threaded dual lead shank was jammed and seized.The internal threads of the head were observed to be stripped.No other issues were identified with the returned components of the device.A review of the device history record was conducted.No issues were identified during the manufacturing and release of this product that could have contributed to the problem reported by the customer.There was no indication that a design or manufacturing issue has caused the issue and hence the root cause cannot be determined.As there has been no issue identified in the manufacturing or release of the device that could have contributed to the problem reported by the customer, this complaint file will be closed with no further action required.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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