Symmetry performed an in-house investigation of this device ((b)(4)) once received.This particular device ((b)(4)) was purchased by the hospital prior to (b)(6) 2012.This device was part of the codman & shurtleff inventory, symmetry surgical did not divest over the codman & shurtleff instrument inventory until (b)(6) 2012.This instrument was sold prior to the divesture of the instrument business.The device ((b)(4)) was evaluated upon return, there was a "repair" marking on the device from (b)(6) 2012.The piece that came apart is an issue with an older version of this product.In the current design, the piece that came apart is now one whole piece-which makes it possible for the device to come apart.Current inventory was inspected; all devices in stock have the new pattern with a solid piece.
|
Sternal retractor came apart during a procedure, metal piece moved while opening the retractor, dislodging bioburden onto sterile field.Instrument did not break.No harm to the patient as a result.No delay in treatment, another device was required to complete the surgery.
|