Offset Reamer Handle, T5766 Product Usage: The reamer handles are re-usable surgical instruments used in arthroplasty surgery of the hip joints, where either total joint replacement or resurfacing surgery is performed using a reamer cutting instrument. The reamer handles are intended for use with a surgical driver (active device). The reamer handle is connected at the distal end to a reamer. The T5766 reamer handle is an offset design with a drive shaft mechanism that spins on roller bearings and is encapsulated in an inner clam shell housing that is constrained within a Radel tube and outer housing.

On June 14, 2016, Greatbatch discovered a significant increase in the number of field complaints for the T5766 Offset Reamer Handle in which the U-joints of the drive chain component seizes during orthopedic procedures rendering the device non-functional. The 2016 failure rate for this failure exceeds the occurrence rate as defined in the DFMEA.

Consignee was sent via e-mail on 10/16/2016 a Greatbatch "Urgent Medical Device Recall" letter dated 10/19/2016 The letter described the purpose of the letter, Reason for Notification, Risk to Health, Recommendation, Instruction to Zimmer. Advised consignee to examine their inventory, quarantine the product and provide a list of the affected countries where the product was distributed. Also requested consignee to complete the Customer Notification Response form and return to Greatbatch at [email protected]. For questions contact your local Greatbatch Medical representative, Monday through Friday via telephone at 1-763-951-8235 8:00 AM (CT) to 5:00 PM (CT), or e-mail us at [email protected] .