Initial reporter is a synthes sales representative.The device was received, the investigation could not be completed, and no conclusion could be drawn, as product is entering the complaint system.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: this mre review is for sterilization procedure only.Part: 04.503.436.01s, lot: 8933492, manufacturing site: bettlach, supplier: (b)(4), release to warehouse date: 15.April 2014, expiry date: 01.April 2024.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Non-sterile part was manufactured in monument.Part: 04.503.436.20, lot: 7585452.Manufacturing location: monument: manufacturing date: 38-jan-2014, part number: 04.503.436.20, 2.4mm ti matrixmandible screw self-tapping 6mm, lot number: 7585452 (non-sterile), lot quantity: 60, work order traveler met all inspection acceptance criteria.Inspection sheet, inspect dimensional / final inspection met all inspection acceptance criteria.Packaging label log lppf 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 dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.Component part(s) reviewed: part number: 21015, tialnbri4.00, lot number: 7412792, lot quantity: 2,021 lbs.Certified test report dated 10-apr-2013 and inspection certificate dated 16-may-2012 were reviewed and determined to be conforming.Lot summary report dated 20-jun-2013 met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the inspection or release of the product that would contribute to this complaint condition.Product was not returned and therefore, no further investigation is possible.This complaint will be rated as confirmed as the investigation performed has shown that the observed damage is consistent with the reported complaint condition.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.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.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.
|