CLASSIC PLUS® NEEDLE HOLDER, CRILE-WOOD, 6 IN.

Description of Event or Problem

COMPLAINANT ALLEGES "DURING PROCEDURES THE TIP IS BREAKING OFF INSIDE THE PATIENT. PIECE IS ABLE TO BE LOCATED AND NO INJURY HAS OCCURRED, BUT THE CLINIC HAS STOPPED USING CURRENT STOCK OF ITEM.".

Additional Manufacturer Narrative

THE DEVICE WAS RETURNED AND EVALUATED, AND THE COMPLAINT WAS CONFIRMED. UPON INSPECTION AND SUBSEQUENT DISCUSSIONS WITH THE SUPPLIER REGARDING THE NATURE OF THE OBSERVED FAILURE, IT WAS CONCLUDED THAT THE ROOT CAUSE WS A SUPPLIER MANUFACTURING ISSUE. THE ISSUE WAS TRACED TO INCONSISTENCIES IN THE SOLDERING PROCESS OF THE TUNGSTEN CARBIDE INSERTS, WHICH COMPROMISED PRODUCT INTEGRITY ACROSS MULTIPLE PRODUCTION LOTS. BASED ON THE SUPPLIER'S INVESTIGATION, IT WAS DETERMINED THAT THE FAILURE IMPACTED PRODUCTION LOTS MANUFACTURED BETWEEN LATE 2024 AND MAY 2025. A DEEPER REVIEW REVEALED THAT A SPECIFIC EMPLOYEE HAD BEEN CONSISTENTLY INVOVLED IN THE SOLDERING TUNGSTEN CARBIDE INSERTS ACROSS THE SUSPECTED AFFECTED LOTS, EXTENDING BEYOND THOSE INITIALLY IDENTIFIED IN THIS COMPLAINT. IN RESPONSE TO THE MULTIPLE CUSTOMER COMPLAINTS OF NEEDLE HOLDER INSERTS BREAKING OFF, THE SUPPLIER HAS BEEN ISSUED A SCAR AND IS REQUESTED TO PROVIDE A DETAILED ROOT CAUSE ANALYSIS ALONG WITH A CORRECTIVE ACTION PLAN TO ADDRESS THE OBSERVED FAILURE. BASED ON THE SUPPLIER'S RECOMMENDATION, THE IDENTIFIED SUSPECT LOTS WILL BE RETURNED TO THEIR FACILITY FOR FURTHER EVALUATION. THIS SHOULD BE CONSIDERED THE FINAL REPORT. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.