UNKNOWN RETRACTOR

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT THA APPROXIMATELY 5 YEARS AGO. DURING THE SURGERY A "POSTERIOR NECK DEFECT CREATED BY RETRACTOR" WAS NOTED. NO ADDITIONAL INTERVENTION WAS REPORTED AS A RESULT OF THIS EVENT. NO FURTHER INFORMATION AVAILABLE.

Additional Manufacturer Narrative

B3: UNKNOWN DATE IN 2020 D10: ALTEON HA COLLARED STEM SIZE: 6 ALTEON CUP, CLUSTER-HOLE 48MM ALTEON NEUTRAL LINER BIOLOX DELTA FEMORAL HEAD, 12/14 TAPER 32MM. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/TECHNIQUE. A REVIEW OF MANUFACTURING DATA WAS UNABLE TO BE PERFORMED AS THE LOT INFORMATION OF THE PRODUCT INVOLVED IN THE EVENT WAS NOT AVAILABLE. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

Additional Manufacturer Narrative

UPON RECEIPT OF ADDITIONAL INFORMATION PERTAINING TO THIS EVENT, IT WAS DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. AS A RESULT, THIS COMPLAINT EVENT IS NO LONGER CONSIDERED REPORTABLE BY EXACTECH AND THIS REPORT MAY BE DISREGARDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.