Patient information is unknown.It is unknown when metal fragments were generated.Additional procode: hwc.It is unknown if or when device was explanted.Complainant part is not expected to be returned for manufacturer review/investigation.Reporter email address is unknown.Part: 04.117.501s; lot: l557541; manufacturing location: (b)(4); release to warehouse date: september 13, 2017; expiry date: september 01, 2027; no nonconformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.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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Device report from synthes europe reports an event in (b)(6) as follows: it was reported that the open reduction internal fixation (orif) was applied to distal humeral fractures on (b)(6) 2018.String-like metal fragments were found when screws were fixed to plates as follows: five screws = 2x va locking screws; 3x va locking screws.Two plates = 1x va-lcp dhp plate, posterolateral: one screw was inserted; 1x va-lcp dhp plate, medial: four screws were inserted.It is unknown which screws were fixed to which plates.It is unknown from where the fragments came.The fragments were removed.The screw was variable angle inserted, and the drill sleeve was secured to the plate.It was confirmed by x-rays that directions of the screw insertions and drill holes matched.Surgery was completed without further incident.There was no adverse consequence to the patient.This report is for a 2.7/3.5mm ti va-lcp medl dstl hum pl/1h/lt/69mm-short-ster.This is report 5 of 7 for (b)(4).
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