Catalog Number 413.375 |
Device Problems
Break (1069); Material Fragmentation (1261)
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Patient Problem
Failure of Implant (1924)
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Event Type
Injury
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Manufacturer Narrative
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Device was used for treatment, not diagnosis.Patient information is not available for reporting.Patient height is (b)(6) meter and (b)(6) centimeters and bmi is (b)(6).(b)(4).(b)(6).Subject device has been received and is currently in the evaluation process.Investigation is ongoing; no conclusion could be drawn as product is entering the complaint system.Dhr has been requested.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 that postoperatively multiple screw heads broke which were used in combination with a locking compression (lcp) distal femur plate.Patient was implanted with a locking compression plate (lcp) distal femur plate and unknown quantity of screws on unknown date.On unknown date it was determined that the heads of multiple screws are broken.Quantity of broken screws is not known.It is also not known if patient will be returned to surgery for removal of the broken devices.This report is for unknown quantity of unknown screws.Concomitant devices reported: 422.253 lot number 8532746 lcp-plate (part / lot: unknown, quantity: 1).This is report 3 of 3 for (b)(4).
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Manufacturer Narrative
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Updated information provided.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: 26 july 2017, it was reported that postoperatively multiple screw heads broke which were used in combination with a locking compression (lcp) distal femur plate.A total of three (3) screws broke post-operatively.
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Manufacturer Narrative
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Part/lot# 413.375/ 9457058.Manufacturing location: (b)(4).Manufacturing date: 27.April 2015.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.A product evaluation was performed.The investigation of the complaint articles indicates that the: dimension- the relevant measurable dimensions of the two locking screws (413.375 / 413.380) can not be determined, because the shafts are missing and the screws head stucks in the lcp-df plate.The hexagon recess of these two locking screws are strongly damaged.Material- the examination of the raw-material testing certificate and the manufacturing papers showed no deviations regarding, dimensions, material analysis, strength and structural stability.The values were in compliance with ao/asif specification and with the international standard iso 5832-11 for tan (wrought titanium 6-aluminium 7-niobium alloy).The fracture face is homogenous, which indicates material conformity.Conclusion- no product fault could be detected.The article 413.375/lot 9457058 was manufactured with a lot size of 240 pieces in april 2015 and we are not aware of any other complaint for this article and lot number.The article 413.380/lot 8212474 was manufactured with a lot size of 239 pieces in december 2012 and we are not aware of any other complaint for this article- and lot number.The evaluation of the two locking screws shown that the screw heads stuck in the lcp-df-plate.The shafts are missing and for further investigation not available.According statement of clinic, the screws were discarded by the hospital.Further investigation of the screw heads are shown that the hexagon recess are strongly damaged.The reason for the breakage and deformation we can not determined.We can only assume that this can be traced during insertion or removal or there was a complication during operation or the healing process that caused this problem.Complaint is disposed as confirmed due to evidence that screws are broken, but it's considered not valid for manufacturing standpoint because there is no evidence of issues manufacturing related.Synthes manufacturing location was discovered upon receipt of subject device.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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Manufacturer Narrative
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Additional narrative: remove verbiage: it is also not known if patient will be returned to surgery for removal of the broken devices.Remove verbiage: date of implant is not known / it is not known if devices were explanted.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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