Catalog Number UNK_KIE |
Device Problem
Failure to Align (2522)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/22/2021 |
Event Type
malfunction
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Manufacturer Narrative
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The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
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Event Description
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The customer reported that: "i am contacting you because our block had a problem on 22/07 with a gamma nail, they did not succeed in locking the distal screw" update 08/02/2021 the customer replied: "for this procedure, we used the distal locking ancillary.The surgeon realized that there was a posterior misdirection of the distal locking screw.Impossible to insert the screw even freehand.We did not keep this screw.The operation instead of lasting 15 minutes lasted 1 hour 35 mm.Material breakage: 2 drills.Patient consequence: the patient could not put his foot down for longer time than expected.
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Event Description
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The customer reported that: "i am contacting you because our block had a problem on 22/07 with a gamma nail, they did not succeed in locking the distal screw".Update 08/02/2021: the customer replied: "for this procedure, we used the distal locking ancillary.The surgeon realized that there was a posterior misdirection of the distal locking screw.Impossible to insert the screw even freehand.We did not keep this screw.The operation instead of lasting 15 minutes lasted 1 hour 35 mm.Material breakage: 2 drills.Patient consequence: the patient could not put his foot down for longer time than expected.
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Manufacturer Narrative
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The risk assessment of the event, performed during the complaint investigation, concluded on an actual severity of harm of s2, which shall be filed as malfunction as per our procedure.The reported event could not be confirmed, since the device was not returned for evaluation and no other evidence was provided.Due to unknown lot code a dhr review was impossible.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.The file will be closed formally in accordance to our procedures.In case the item and/or substantive information will become available in future the file will be reviewed and reopened.
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Search Alerts/Recalls
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