STRYKER TRAUMA KIEL RECONSTRUCTION NAIL R1.5, TI, RIGHT T2 RECON Ø10X320 MM X 125°; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Catalog Number 18451032S |
Device Problems
Break (1069); Improper or Incorrect Procedure or Method (2017)
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Patient Problem
Non-union Bone Fracture (2369)
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Event Date 05/16/2017 |
Event Type
Injury
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Manufacturer Narrative
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Device will not be returned.If additional information becomes available it will be provided on a supplemental report.Device was discarded.
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Event Description
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Primary surgery using t2r was performed on (b)(6) 2014.After that the fracture did not heal and revision surgery using g3l was performed on (b)(6) 2017.During g3l surgery, as lag screw guide wire induced to the hole of the t2r lag screw, it was not inserted properly.The surgeon gave up the step drill procedure and inserted u-lag screw to the patient.Also the u-lag screw was not inserted properly, the tip of the u-lag screw driver broke after repeated trial and error.The surgery was finished with the screw projecting to lateral slightly.U-blade and u-endcap were not used.This pi to cover the revision surgery and related to (b)(4).
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Manufacturer Narrative
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The evaluation revealed the t2 recon nail to be the primary product.No deviations were found during review of the manufacturing and inspection documents (dhr).The nail was documented as faultless prior to distribution.An investigation was not possible because the nail and x-rays were not available.According to the customer the bone fracture did not heal after a period of approx.2,6 years; the explanted nail was not broken.It can be assumed that the nail was not damaged and did not contribute to the not healed fracture.According to stryker internal literature research (statement (b)(4)) bone fractures of femur bones have a normal healing range of approx.6 months, a healing period of >6 months can be classified as non-union.Non-unions can have several reasons and are listed as adverse effects in the ifu.Based on the given information and the fact that no manufacturer related issues were found the case was classified to be patient related (non-union).Review of complaint history, capa databases, risk analysis and labeling did not identify any discrepancies.There are no open actions in place related to the reported event for the subject product(s).No non-conformity was identified.Device was not received.
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Event Description
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Primary surgery using t2r was performed on (b)(6) 2014.After that the fracture did not heal and revision surgery using g3l was performed on (b)(6) 2017.During g3l surgery, as lag screw guide wire induced to the hole of the t2r lag screw, it was not inserted properly.The surgeon gave up the step drill procedure and inserted u-lag screw to the patient.Also the u-lag screw was not inserted properly, the tip of the u-lag screw driver broke after repeated trial and error.The surgery was finished with the screw projecting to lateral slightly.U-blade and u-endcap were not used.This pi to cover the revision surgery and related to pi (b)(6).
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Search Alerts/Recalls
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