OBERDORF SYNTHES PRODUKTIONS GMBH BROCA MATRIXMANDIBLE 1.5 2AREST-CORT P/; DRILL, BONE, POWERED
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Catalog Number 03.503.476S |
Device Problem
Break (1069)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/26/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Complainant part is expected to be returned for manufacturer review/investigation but has yet to be received.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.
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Event Description
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Device report from synthes, reports an event in (b)(6) as follows: it was reported that, on (b)(6) 2019, during an unknown procedure there was an issue with the trans-buccal drill bits.None would cut and one broke, tips blackened.No fragments were left in the patient.A standard intra-oral drill bit was used as a replacement.This complaint involves four (4) devices.This report is for one (1) matrixmandible 1.5mm drill bit j-latch for 03.503.045/.047.This is report 2 of 4 for (b)(4).
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Manufacturer Narrative
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Product complaint # (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.Device history lot mre for sterilization: part number: 03.503.476s, synthes lot number: 1l54318, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 19.Sep.2018, expiry date: 01.Sep.2028.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Mre for non sterile part: 03.503.476 / u305450.Manufacturing location: supplier - orchid / inspection, packaging and release by: monument release to warehouse date(s): 20-mar-2018 quantity 280 / 25-may-2018 quantity 55 / 16-aug-2018 quantity 161 part number: 03.503.476, matrixmandible 1.5mm drill bit j latch for 03.503.045/.047 lot number: u305450 (non-sterile) lot quantity: 496 total (three batches 280, 55 and 161) purchased finished goods travelers met all inspection acceptance criteria.Inspection sheets, incoming final inspection 03if503476 rev j met all inspection acceptance criteria.Certificates of conformance supplied by orchid dated 24-feb-2018 were reviewed and determined to be conforming.Heat treat specified at hrc 50-55; certified hardness value of hrc 50.4.Packaging label logs (pll) lppf rev b were reviewed and determined to be conforming.Note: two batches labeled for usa and one batch labeled for ous (ce mark).This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the inspection, packaging or release that would contribute to this complaint condition.Device history batch null, device history review 10-dec-2019: dhr 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.H3, h6: investigation summary the complaint condition that the drill bit did not cut or broke during use, cannot be confirmed according to the received pictures.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.
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Event Description
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Update: this report is 3 of 6 for (b)(4).
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Manufacturer Narrative
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Product complaint # (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.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.
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