Product complaint # (b)(4).Additional product code: ktt.Complainant part is not expected to be returned for manufacturer review/investigation.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.
|
Device report from synthes reports an event in (b)(6) as follows: it was reported on that (b)(6) 2021, the patient underwent for a revision surgery due to the implant cut-out occurred.It was unknown if the revision surgery completed successfully.The patient outcome was unknown.The patient had orif surgery for the trochanteric femur on (b)(6) 2021.No further information is available.Concomitant device reported: unk - nails: tfna (part#: unknown, lot#: unknown, quantity: 1).Unk - screws: locking (part#: unknown, lot#: unknown, quantity: unknown).This complaint involves (1) device.This report is for (1) tfna fenestrated helical blade 85mm - sterile.This report is 1 of 1 for (b)(4).
|
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.H10 additional narrative: h3, h4, h6: manufacturing location: elmira / packaged, sterilized and released by: monument.Manufacturing date: march 19, 2021.Expiration date: march 1, 2031.Part number: 04.038.385s, tfna fenestrated helical blade 85mm -sterile.Lot number: 95p6445 (sterile).Note: helical blade was manufactured by elmira; lot numbers 94p0004 quantity (b)(4) / 94p0005 quantity (b)(4).Parts were packaged, sterilized and released by monument.Production order traveler met all inspection acceptance criteria.Packaging label log (pll) lmd was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.This lot met all visual, sterility and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.This lot met all visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Product was not returned.Based on the information available, it has been determined that no corrective and 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.H5.
|