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Product complaint # (b)(4).Expiration date unknown.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.A review of the device history record has been requested.The investigation could not be completed; 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.
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Device report from synthes reports an event in japan as follows: it was reported that the plate (04.503.739s) broke when the surgeon was bending it during a mandibular reconstruction surgery on (b)(6) 2019.The surgery was completed within a 30 minutes surgical delay, and there was no harm to the patient.No further information is available.Concomitant device reported: unknown bending instrument: plate bender: trauma (part# unknown, lot# unknown, quantity# 1).This complaint involves one (1) device.This report is 1 of 1 for (b)(4).
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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, h6: the device was received, the investigation is in progress, 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.
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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: part: 04.503.739s, lot: 4l50692, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 06.May 2019, expiry date: 01.April 2029.As this complaint is neither packaging nor sterilization related only the manufacturing documents of the unsterile device 04.503.739 with lot h865105 were reviewed: 13-feb-2020 jonathan cortright (elmira).Part number: 04.503.739, lot number: h865105, part manufacture date: 09-apr-2019, manufacturing location: elmira, part expiration date: n/a, nonconformance noted: n/a.Dhr record review: a review of the device history record revealed no complaint related anomalies.The device history record shows this lot of ti matrixmandible 7x23 angle recon pl left 2.5mm thick product was processed through the normal manufacturing and inspection operations with no rework nor nonconformities noted.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.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.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.Visual inspection: the plate is broken apart at the crossover between hole 14 and 15 counted from the end of the longer side.The plate was bent out of plane before it broke and there are very deep nicks in the area of the fracture visible.The rest of the plate is bend in different directions for contouring, there are all over the plate clearly visible deep nicks from a bending tool.The shorter end of the plate was cut between hole 3 and 4 for length adaption.Dimensional inspection: feature: width (measured at the next intact crossover) result: pass.Feature: thickness (measured at the next intact crossover) result: pass.Drawing/specification review: 1.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.A review of the raw material device history record revealed this lot met all specifications with no nonconformance noted.This raw material lot met all dimensional and visual criteria at the time of manufacture with no issues documented during the manufacture that would contribute to this complaint condition.2.The matrixmandible plating system surgical technique was reviewed.Following relevant statements were found.- warning: these devices can break intraoperatively when subjected to excessive forces or outside the recommended surgical technique - precaution: minimize notching or scratching of the implant during contouring.These factors may produce internal stresses which may become the focal point for eventual breakage of the implant.- precautions: avoid reverse bends as it may weaken the plate and lead to premature implant failure.Avoid sharp bends.Sharp bends include a single out-of plane bend of >30 degrees between two adjacent holes - the review has also shown that for out of plane bending like in this case either the bending irons parts 03.503.077 and 03.503.078 or the bending pliers with nose part 03.503.056 should be used.If the bending pliers with nose is used the with out of plane and second step marked part of the tool has to be used.The duckbill end of the bending pliers with nose is used to bent the last segment of a plate, which is accordingly marked on the device.Summary the complaint is confirmed as the plate is broken apart as complained.Based on the findings above a manufacturing related issue can be excluded.There was no information provided which bending tool was used, also how the tool was used is unknown.The several very deep nicks in a short distance next to the breakage indicate that the plate was exposed to high forces in this area.Also there are deep nicks on both sides of the plate in the fracture area, while on other contoured places the nicks are only on one side.This is a indication for back and forth bending and as stated in the surgical technique should reverse bends be avoided as this weakens the plate and can finally lead to a breakage.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.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.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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