Model Number 03.019.016 |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problem
No Patient Involvement (2645)
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Event Type
malfunction
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Manufacturer Narrative
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Initial reporter is a synthes sales consultant complainant part is not expected to be returned for manufacturer review/investigation.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.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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It was reported on (b)(6) 2019 during an inspection at sterile processing department, the insertion handle, aiming arm, connecting screw, aiming arm knob, three (3) drill sleeve and three (3) protection sleeve of the multiloc humeral nail instruments did not accurately target holes in nail with drill bits.There is no patient involvement.Additional devices for this event are captured on related complaint (b)(4).This report is for a drill bit.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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Event Description
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Concomitant device: mulitloc humeral nail (part/lot unknown, quantity 1).
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Search Alerts/Recalls
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