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Catalog Number 04.117.103S |
Device Problem
Device-Device Incompatibility (2919)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/29/2022 |
Event Type
malfunction
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Event Description
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Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6), 2022, the patient underwent the osteosynthesis surgery for distal humerus fracture with the plate in question.
In the surgery, the locking mechanism of the plate hole did not work normally in the most distal right hole of the plate.
Therefore, the plate was replaced with a new one.
The surgery was completed successfully with 60 minutes delay.
No further information is available.
This report is for one (1) va-lcp dhp 2.
7/3.
5 dorso-lat w/supp-lat.
This is report 1 of 1 for complaint product complaint (b)(4).
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Manufacturer Narrative
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Reporter is a j&j employee.
Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.
The investigation could not be completed; no conclusion could be drawn, as no product was received.
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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Search Alerts/Recalls
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