Catalog Number 00249000430 |
Device Problem
Positioning Failure (1158)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 05/27/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-02562, 0001822565-2020-02561, 0001822565-2020-02876.Concomitant medical devices: item# 00249000424; lot# 61793873; item# 00249000432; lot# 63206145; item# 00249000431; lot# 63199333.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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It was reported approximately three (3) months ago during an initial surgery, the retrograde nail jig attachment would not line up to the proximal holes.There was a 35 minute delay.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Visual examination of the returned product identified damages in the form nicks and scratches indicating usage of the devices.The dimensional analysis of the targeting guide was conforming to specifications during manufacturing.The device was assembled without any difficulty.The devices has 5 and 9 years of field service age and it is unknown how many times the device was used.The nail was not returned and it is cannot be confirmed the orientation and placement of the nail jig.Reported event is not related to a combination of products; therefore a compatibility review is not applicable.Medical records were not provided.Dhr was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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