APTUS

Additional Manufacturer Narrative

THE ADVERSE EVENT DID NOT MEET MANDATORY REPORTING CRITERIA.

Description of Event or Problem

ADVERSE EVENT OCCURED IN THE UNITED KINGDOM. WHILE DRILLING DURING A SURGICAL PROCEDURE, THE TIP OF THE DRILL BIT BECAME BROKEN, AND THE BROKEN TIP OF THE DRILL BIT WAS LEFT INSIDE THE PATIENT'S BONE AS DECIDED BY THE SURGEON.THE BROKEN DRILL BIT WAS DOCUMENTED IN THE PATIENT'S OPERATION NOTE, AND IN THE THEATRE ELECTRONIC RECORD. THE PATIENT HAD BEEN AWAKE FOR THEIR SURGERY AND SO WOULD HAVE BEEN INFORMED AT THE TIME OF THE OPERATION. THE PATIENT WAS REVIEWED IN CLINIC ON A LATER DATE BY A CONSULTANT SURGEON, WHO HAD NO CONCERNS WITH THE PATIENT'S OPERATION SITE. FURTHER UPDATE FROM THE SURGEON: THE REGISTRAR WAS DRILLING THE LAST PROXIMAL SHAFT SCREW AND BENT THE DRILL DURING DRILLING, CAUSING IT TO SNAP AT THE BONE-PLATE INTERFACE. THERE WAS NO CHANGE TO THE POST-OPERATIVE INSTRUCTIONS.

Additional Manufacturer Narrative

IF ADDITIONAL INFORMATION BECOMES AVAILABLE, MEDARTIS AG WILL PROVIDE AN UPDATE.

Description of Event or Problem

ADVERSE EVENT OCCURED IN THE UNITED KINGDOM. UNFORTUNATELY THE END OF A DRILL TIP WAS BROKEN DURING USE AND REMAINED INSIDE THE PATIENT'S BONE.

Description of Event or Problem

EVENT OCCURED IN THE UNITED KINGDOM. WHILE DRILLING DURING A SURGICAL PROCEDURE, THE TIP OF THE DRILL BIT BECAME BROKEN, AND THE BROKEN TIP OF THE DRILL BIT WAS LEFT INSIDE THE PATIENT'S BONE AS DECIDED BY THE SURGEON. THE BROKEN DRILL BIT WAS DOCUMENTED IN THE PATIENT'S OPERATION NOTE, AND IN THE THEATRE ELECTRONIC RECORD. THE PATIENT HAD BEEN AWAKE FOR THEIR SURGERY AND SO WOULD HAVE BEEN INFORMED AT THE TIME OF THE OPERATION. THE PATIENT WAS REVIEWED IN CLINIC ON A LATER DATE BY A CONSULTANT SURGEON, WHO HAD NO CONCERNS WITH THE PATIENT'S OPERATION SITE. FURTHER UPDATE FROM THE SURGEON: THE REGISTRAR WAS DRILLING THE LAST PROXIMAL SHAFT SCREW AND BENT THE DRILL DURING DRILLING, CAUSING IT TO SNAP AT THE BONE-PLATE INTERFACE. THERE WAS NO CHANGE TO THE POST-OPERATIVE INSTRUCTIONS. THE DEVICE WAS MANUFACTURED WITHIN SPECIFICATIONS.

Additional Manufacturer Narrative

THE ADVERSE EVENT DID NOT MEET MANDATORY REPORTING CRITERIA.