STRYKER TRAUMA KIEL SET SCREW, TI GAMMA3® Ø8X17.5MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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Catalog Number 30030822S |
Device Problem
Insufficient Information (3190)
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Patient Problem
Bone Fracture(s) (1870)
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Event Date 12/14/2015 |
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.
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Event Description
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This product inquiry addresses 3 intra-operative femur fractures in conjunction to the gamma3 system.Screw was removed.The manufacturer became aware by an (b)(6) publication ¿how evolution of the nailing system improves results and reduces orthopedic complications: more than 2000 cases of trochanteric fractures treated with the gamma nail system¿, published on 14th december 2015 regarding the gamma system (sgn, tgn, gamma3 ¿ all trochanteric nails) that in sum 63 patients had been observed presenting 11 adverse events in a period from january 1997 to december 2011.It was not possible to ascertain specific device or patient information from the article, a review of the complaint handling database revealed that the events had not been reported by the hospital or by the author of the publication, therefore 11 complaints were initiated retrospectively.
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Manufacturer Narrative
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Corrections to describe event or problem.
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Event Description
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This product inquiry addresses 3 intra-operative losses of self-retaining set screws in conjunction to the gamma3 system.Screw was removed.The manufacturer became aware by an italian publication ¿how evolution of the nailing system improves results and reduces orthopedic complications: more than 2000 cases of trochanteric fractures treated with the gamma nail system¿, published on 14th december 2015 regarding the gamma system (sgn, tgn, gamma3 ¿ all trochanteric nails) that in sum 63 patients had been observed presenting 11 adverse events in a period from january 1997 to december 2011.It was not possible to ascertain specific device or patient information from the article, a review of the complaint handling database revealed that the events had not been reported by the hospital or by the author of the publication, therefore 11 complaints were initiated retrospectively.
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