VERSIPASS NEEDLE

Description of Event or Problem

THE COMPLAINT WAS REPORTED FROM STRYKER INVOLVING THE VERSIPASS NEEDLE MANUFACTURED BY LINCOTEK MEDICAL LLC. THE EVENT TOOK PLACE IN THE UNITED STATES. DURING A SURGICAL PROCEDURE ON (B)(6) 2026, TWO VERSIPASS NEEDLES FRACTURED DURING USE. THE FIRST NEEDLE FRACTURED APPROXIMATELY HALFWAY DOWN THE SHAFT DURING DEPLOYMENT. A SECOND NEEDLE WAS SUBSEQUENTLY OPENED AND USED; HOWEVER, THIS NEEDLE FRACTURED AT THE DISTAL TIP IN TWO LOCATIONS RESULTING IN BROKEN NEEDLE FRAGMENTS BECOMING DISLODGED INTO THE PATIENT'S MENISCUS. X-RAYS WERE UTILIZED TO IDENTIFY AND LOCATE THE RETAINED NEEDLE FRAGMENTS. APPROXIMATELY ONE HOUR OF ADDITIONAL SURGICAL TIME WAS REQUIRED TO LOCATE AND RETRIEVE THE BROKEN NEEDLE PIECES FROM THE PATIENT. DUE TO THE PRESENCE OF RETAINED FRAGMENTS AND THE EFFORTS REQUIRED FOR RETRIEVAL THE PLANNED MENISCUS REPAIR PROCEDURE COULD NOT BE COMPLETED AS INTENDED. INSTEAD, A PARTIAL LATERAL MENISCECTOMY WAS PERFORMED IN ORDER TO REMOVE THE NEEDLE FRAGMENTS ALONG WITH THE AFFECTED MENISCAL TISSUE. THE EVENT RESULTED IN PATIENT INVOLVEMENT, MEDICAL INTERVENTION, AND A SURGICAL DELAY. PHOTOGRAPHS OF THE BROKEN NEEDLES AND X-RAYS WERE PROVIDED WITH THE COMPLAINT.

Additional Manufacturer Narrative

SINCE THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER (LINCOTEK MEDICAL), THE INVESTIGATION WAS MAINLY PERFORMED ON THE THE DHR. THE ASSEMBLY LEVEL LOT # IS 1007830 AND THE PACKAGING LEVEL LOT # IS 1008625. THERE WERE NO ISSUES IDENTIFIED DURING THE DHR REVIEW. THE IFU FOR THE DEVICE CLEARLY SPECIFIES "USE OF EXCESSIVE FORCE TO GRASP TISSUE MAY CAUSE INTRUMENT BREAKAGE OR PATIENT INJURY". THE USER MAY HAVE USED EXCESSIVE FORCE IN THIS CASE BUT THE CAUSE IS UNKNOWN. THIS COMPLAINT WAS CONSIDERED REPORTABLE AS A FRAGMENT OF THE NEEDLE HAD TO BE REMOVED BY PERFORMING A LATERAL MENISCECTOMY.