The device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.(b)(4).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 (b)(6) reports an event as follows: it was reported that during a hardware removal on (b)(6) 2019, the screw heads were broken, and the screw threads were damaged.During removal surgery, the surgeon had difficulty in removing the screws using a screwdriver with handle.Upon removal of the screws from the plate, the surgeon could not transmit power to the screw well, and the screw head was broken and damaged.Additionally, the locking screws and the plate were rotated and were removed by cutting the plate.The patient¿s mandible was partially scraped.Initially, the patient was implanted with matrixmandible reconstruction plate and screws on (b)(6) 2019.The procedure was successfully completed with a sixty (60) minute surgical delay reported.Patient condition was stable.Concomitant devices: handle with hexagonal coupling (part: 311.006, lot: unknown, quantity: 1).This report is for a 2.4mm titanium (ti) matrixmandible screw.This is report 7 of 10 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.The received matrixmand reco-plate is broken into four (4) pieces.One screw was drilled out form the plate hole and the shaft is badly damaged.Another screw is remaining in one of the plate holes and the recess is badly damaged.The other 6 screws show sings of use at the recess, the threads otherwise are still in a good condition.Furthermore, the screwdriver tip is worn down and should be replaced.Because of the damages the complaint relevant dimensions cannot be checked to print specifications anymore.The manufacturing review shows that the production procedure was according to the specifications and there were no issues that would contribute to this complaint condition.Failure in material or production could not be detected.The correct materials were used with correct hardness after the procedure and documented.The received condition of the device is concordant with the complaint description and the complaint condition is confirmed.Based on the provided information we are not able to determine the exact cause of this complaint.Multiple factors can lead to technical difficulties during removal of the plate.These factors include, but are not limited to: wrong torque or angulation of the screw during insertion leading to cold-welding between the plate and the screw thread, or proteins which are forming a bond between the plate and screw thread.Some of these factors are patient specific factors or they depend on the proper care of the surgeon, and can thus not be investigated nor controlled by depuy synthes.Since not all of them can be investigated and excluded from the root cause analysis, no final statement about the cause of such issues during plate removal can be made.The bad condition of the screwdriver, which arose during the years (produced in november 2009), may also have played a contributory negligence.End of life of a device is normally determined by wear and damage due to use.Evidence of damage and wear on a device may include but is not limited to corrosion (i.E.Rust, pitting), discoloration, excessive scratches, flaking, wear and cracks.Improperly functioning devices, devices with unrecognizable markings, missing or removed (buffed off) part numbers, damaged and excessively worn devices should not be used.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed as no product related issue could be detected.Device history review this mre review is for sterilization & assembling procedure only part: 04.503.646.01s.Lot: l417096.Manufacturing site: bettlach.Supplier: (b)(4).Release to warehouse date: 18.May 2017.Expiry date: 01.May 2027.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: 04.503.646.20.Lot: h324895.Manufacturing location: monument.Manufacturing date: 23-mar-2017.Part number: 04.503.646.20, 2.4mm ti matrix mandible locking screw slf-tpng 16mm.Lot number: h324895 (non-sterile).Lot quantity: (b)(4).Work order traveler met all inspection acceptance criteria.Packaging label log was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.Component part(s) reviewed: part number: 04.503m646.Lot number: h324895.Lot quantity: (b)(4).Work order traveler met all inspection acceptance criteria.Inspection sheet, inspect dimensional / final inspection, met all inspection acceptance criteria.Packaging label log 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.Part number: 21015, tialnbri4.00.Lot number: h275132.Lot quantity: (b)(4) lbs.Certified test report supplied by perryman company dated 09-feb-2016 was reviewed and determined to be conforming.Lot summary report dated 12-jan-2017 met all inspection acceptance criteria.Raw material receiving/putaway checklist met all inspection acceptance criteria.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.
|