The manufacturer became aware of a study from department of orthopaedic surgery, pediatric center (b)(6).The title of the study is ¿complications at screw removal in slipped capital femoral epiphysis treated by cannulated titanium screws¿ which was published in 23-may-2006 and is associated with the asnis iii single cannulated titanium screw.Within that publication, intraoperative/ postoperative complications/ adverse events were reported, which occurred from 2003 to 2005.It was not possible to ascertain specific catalog number or patient information from the report, however, based on the review of the study devices have been identified as asnis iii single cannulated titanium screw with 8mm diameter and 25 mm thread length.A review of the complaint handling database revealed that the events have not been reported previously, therefore 18 complaints were initiated retrospectively for different adverse events mentioned in the report.This product inquiry addresses difficulties in hardware retrieval because of screw head damage.3 out of 6 cases.Adverse consequences reported that pin (asnis iii screw) was extracted with the aid of jacob¿s chuck that may have led to prolonged surgery time.The study states, ¿the extraction forces needed were extremely high.[¿] 12 pins could be backed only 10¿15 mm before they got stuck.The head of the pin was cut off.[¿] in six cases the rest of the rest of the pin could be extracted with the aid of a jacob¿s chuck.[¿] the allen socket was worn out in all cases where the surgeon had difficulties to retrieve the hardware.[¿] difficulties in hardware retrieval were encountered in various insertion angles, pin lengths, and pin positions.They were seen on the slipped side as well as on the side pinned prophylactically.¿.
|