[21045454]
These tri-clamps were used with allen universal leg stirrups. The clamps mount to a surgical table and the leg stirrups are mounted into the clamp. The patient was anesthetized. During surgery the clamp loosened, lowering the left leg. The leg was reposition and redraped. An rax-ay of the left hip was taken and read. The doctor reported "no gross fracture" and recommended a follow up study post-operatively. Biomedical services was calle dto receive the device. Subsequent investigation shows these clamps were distributed through allen medical. A manufacturer recall of this device was made four to five years ago because "if dropped or banged the locking knob can crack causing device failure". Some one of amatech corporation told us that our serical number and the age of the clamp fell into the recall qualifications. We were asked to return the device and replacement would be sent to us. Both clamps (rt/lt leg) were returned to the manufacture. The hospital has no record of receiving a recall notice for this device. The knob fracture may be undetectable to the userdevice not labeled for single use. Patient medical status prior to event: unknown. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: actual device involved in incident was evaluated, mechanical tests performed, visual examination. Results of evaluation: none or unknown. Conclusion: device evaluated and alleged failure could not be duplicated. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device permanently removed from service, device recalled by manufacturer/distributor. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5