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Catalog Number 04.005.414S |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Neuropathy (1983)
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Event Date 04/06/2022 |
Event Type
Injury
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Manufacturer Narrative
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Additional device product codes hsb complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j employee.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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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 surgery using mhn left short nail for proximal end of humerous fracture with the screws in question.The surgery was completed successfully without any surgical delay.After the surgery, it was confirmed on (b)(6) 2022, during a meeting between the sales rep and the surgeon that patient developed radial neuropathy.There is no plan for re-operation at this point, and the patient have been continuing to be followed up with a brace on the affected area.The surgeon has thought that the screws are stimulating the nerve.No further information is available.This report is for one (1) lockscr ø4 l24 f/nails tan dblue.This is report 1 of 2 for complaint (b)(4).
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Search Alerts/Recalls
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