HEWSON SUTURE RETRIEVER

Description of Event or Problem

IT WAS REPORTED THAT DURING A PARTIAL PATELLECTOMY WITH PATELLAR TENDON ADVANCEMENT FOR PATELLA FRACTURE A SMITH & NEPHEW HEWSON SUTURE RETRIEVER WAS BEING USED WHEN A PIECE OF THE PASSER LOOP BROKE OFF AND WAS UNABLE TO BE RETRIEVED.

Additional Manufacturer Narrative

THE ASSOCIATED COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION. IT WAS REPORTED THAT A PIECE OF THE PASSER LOOP FROM THE HEWSON SUTURE RETRIEVER BROKE OFF AND WAS UNABLE TO BE RETRIEVED, AND REMAINS IN THE PATIENT. IT HAS BEEN REQUESTED TO IDENTIFY THE EXACT PIECE OF THE DEVICE THAT IS RETAINED, AS THERE ARE DIFFERENT MATERIAL COMPOSITIONS FOR EACH COMPONENT OF THE DEVICE. THEREFORE, WITHOUT KNOWING WHAT PORTION REMAINS IN THE PATIENT AT THIS TIME, THE MATERIAL COMPOSITION/BIOCOMPATIBILITY CANNOT BE DETERMINED AT THIS TIME. ADDITIONAL COMMUNICATION STATES THAT THE PATIENT HAS EXHIBITED NO ADVERSE SYMPTOMS TO THIS DATE, AND THE NEED FOR REVISION SURGERY HAS NOT BEEN INDICATED. THE FUTURE IMPACT TO THE PATIENT CANNOT BE DETERMINED. NO FURTHER CLINICAL ASSESSMENT CAN BE PERFORMED. A REVIEW OF COMPLAINT HISTORY DID NOT REVEAL ADDITIONAL COMPLAINTS FOR THE LISTED BATCH. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL ANY MATERIAL OR MANUFACTURING DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER, WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. WE CONSIDER THIS INVESTIGATION CLOSED.