Catalog Number 04.503.610.01S |
Device Problem
Break (1069)
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Patient Problem
Not Applicable (3189)
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Event Type
malfunction
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Manufacturer Narrative
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Patient date of birth and weight not available for reporting.Date of device breakage is not known.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.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 europe reports an event in (b)(6) as follows: it was reported patient underwent an open reduction internal fixation (orif) of the mandible on (b)(6) 2013.During the removal procedure on (b)(6) 2018, it was noted that two (2) of the screws were broken at the middle of the screw thread.The remaining four (4) screws were removed without incident and intact.There was an unspecified surgical delay, but procedure was completed successfully with no harm to patient.This report is for one (1) 2.0mm matrixmandible locking screw.This is report 2 of 2 for (b)(4).
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Manufacturer Narrative
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Added concomitant devices.Device returned to manufacturer the subject device has been received and the product evaluation is in progress.No conclusion can be drawn.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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Concomitant devices reported: matrixmandible screws (part # unknown, lot # unknown, quantity 4), ti matrixmandible 3x3h dcp pl 1.25mm thick (part # 04.503.712s, lot # 3272908, quantity 1).
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Manufacturer Narrative
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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, h4, h6: dhr review was completed.Part no.: 04.503.610.01s.Lot no.: 7942263.Manufacturing location: bettlach.Supplier: (b)(4).Release to warehouse date: 13.Jun.2012.Expiry date: 01.Jun.2022.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.Non-sterile 04.503.610.20 / 6944410 was manufactured in us, monument.Manufacturing location: monument.Manufacturing date: 16-may-2012.Part #: 04.503.610.20, lot#: 6944410 (non-sterile) - 2.0mm ti matrixmandible locking screw slf-tpng 10mm.Quantity 100.Inspection sheet- inspect dimensional final inspection no: met inspection acceptance criteria.Raw material part 21015, lot 6105091 reviewed meet specification.Raw material was received from (b)(4) company.Certified test report & certificate of test for titanium received from (b)(4) meet specification.Raw material receiving/putaway checklist meet requirements.No ncrs were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.H3, h6: customer quality conducted an investigation of the returned device.As received: received one plate and seven screws.Two of the screws are broken in two sections.The broken screws have damaged threads and there is damage around the break area.There is also debris in the screw threads.Investigation summary: review of the device history record showed that there were no issues during the manufacture of this product, and any subcomponents, which would contribute to this complaint condition.The material was checked with a niton xray analyzer gun and was confirmed to be the correct; tialnb.The flutes, thread profile and thread minor diameter could not be checked due to damage or feature unavailability.The available data supports the complainant¿s description of the complaint condition of "screw breakage" therefore this complaint is confirmed.However, since the features relevant to the complaint condition could not be evaluated it is unknown if the cause of the complaint condition is a result of the manufacturing process.Therefore, complaint is not confirmed from a manufacturing standpoint.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.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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Search Alerts/Recalls
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