Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.Reporter is jnj representative.The investigation could not be completed, no product was received; no conclusion could be drawn at the time of filing this report.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.
|
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.H3, h6: part: 03.113.022, lot: 8558945, manufacturing site: hägendorf, release to warehouse date: september 05, 2013.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Visual inspection: the 1.6mm percutaneous threaded wire guide and handle f/percutaneous threaded drill guides were received assembled at customer quality (cq).Both devices were found stuck/ locked, it was not able to disassemble/separate mating device.Hence, the complaint is confirmed.Functional testing: multiple attempts were tried to separate the both the devices.But, they were not able to be separated.Dimensional inspection: a dimensional inspection was not performed as stuck features were inaccessible without destruction of the device.Document/specification review: -fuehrungs-bohrhuelse ø1.6guiding drillsleeve ø1.6 3.5 lcp aiming systems conclusion: the complaint is partially confirmed.A definitive root cause could be determined it is possible that the device encountered unintended forces (during usage or handling at the time of surgery) which may led devices to be jammed.During the investigation, no unidentified product design/manufacturing issues or discrepancies were observed that may have contributed to the complaint condition.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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.
|