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Device Problem
Improper or Incorrect Procedure or Method (2017)
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Patient Problems
Injury (2348); No Code Available (3191)
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Event Date 07/17/2019 |
Event Type
Injury
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Manufacturer Narrative
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This report is for an unknown nail/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a synthes employee.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(b)(4).Device was used for treatment, not diagnosis.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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Device report from (b)(6) reports an event as follows: it was reported that during an emergency procedure on (b)(6) 2019, the surgeon planned to place a 10 mm diameter nail and verified in situ that it had not been delivered.Instead, the surgeon attempted to place a 9 mm nail, however, its entrance to the canal could not progress; it was changed to an 8 mm x 315 nail.The nail was placed with resistance and displaced the fracture.When locking the nail in the distal hole, the drill bit progressed without difficulty.In the next hole, a slight resistance was felt and a strange noise was heard; a type of cortical noise.The drill bit broke.The surgeon selected another drill bit.The drill entered to a certain extent and then encountered resistance.Again, the drill bit broke.After reviewing the two drill bit fragments in the bone space, the surgeon decided to leave them in the patient.Procedure outcome is unknown.There was no reported patient consequence.This report is for an unknown nail.This is report 4 of 4 for (b)(4).
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Manufacturer Narrative
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Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.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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