Complainant part is not expected to be returned for manufacturer review/investigation.A device history record (dhr) review was conducted: part #: 04.117.401s, lot #: 73p1473, manufacturing site: (b)(4), release to warehouse date:04 nov 2020, expiry date: 01.Oct.2030.A manufacturing record evaluation was performed for the sterile lot number, and no non-conformance's were identified.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.
|
Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2020, the patient underwent the osteosynthesis surgery for the distal humerus with the plate.During the plate bending, the plate cracked.The surgeon used another plate and the surgery was completed successfully within thirty (30) minutes delay.Patient outcome is reported as stable.No further information is available.This report is for one (1) 2.7/3.5mm ti va-lcp medl dstl hum pl/1h/rt/69mm-short-ster.This is report 1 of 1 for (b)(4).
|