It was reported that during acl reconstruction surgery, when opening the package, the biosure was found fractured.The procedure was successfully completed without delay using a s&n back-up device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
|
H10: h2, h3, h6.The reported 72202745 7-8 mm biosure sync, used in treatment, has returned for evaluation.One of the four fins have broken off.An exact root cause cannot be determined with confidence; however, factors that could have contributed to the reported event include: excessive force placed on the device during insertion.The instruction for use outlines precautionary statements and instructions in regards to the use of the device to avoid damage or non-functionality.A review of the manufacturing and complaint records was performed for the reported lot, there were no indications that would suggest that the device did not meet product specifications upon release into distribution.
|