Device report from synthes reports an event in portugal as follows:
it was reported on an unknown date that etn set marked for etn pin extraction.Also sent iln universal pin extension set.It was sent from iln , and instead of sending the etn ext set sent the set of ext broken pins.Anesthetized patient and surgeon without material to extract the pin.Surgery took long, opened sets and sets of material to try to find a solution that allowed the implant to be removed.Damaged parts belonging to other instruments
the product complaint (b)(4) was opened on 6/20/2022, for a damaged product.There is no further information.This report is for one (1) scrdriver t25 l330.This is report 1 of 5 for complaint (b)(4).
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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.If the information is unknown, not available or does not apply, the section/field of the form is left blank.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter is a j&j sales representative.(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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