GEM MICROVASCULAR ANASTOMOTIC COUPLER

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D4, D9, H3, H4, H6(UPDATE CODES), H11. H11: THE TWO 2.5MM COUPLERS WERE RECEIVED FOR EVALUATION, THE TWO JAW ASSEMBLIES AND FOUR UNCONTAINED RINGS WERE RETURNED IN A PLASTIC CONTAINER WITH A DRY FIBROUS TOWELETTE. DURING THE VISUAL INSPECTION, THE PINS ON ALL FOUR RINGS WERE IN GOOD CONDITION; HOWEVER, THERE WERE INDENTATIONS AND MARKINGS OBSERVED ON THE PLASTIC PORTION OF EACH RING. THERE WERE NO ABNORMALITIES OR DAMAGE OBSERVED ON EITHER OF THE 2.5MM COUPLER JAW ASSEMBLIES. A FUNCTIONAL INVESTIGATION WAS PERFORMED ON THE RETURNED SAMPLE, THE JAW ASSEMBLY CLOSED PROPERLY, AND THE JAWS SPRUNG OPEN AFTER REMOVAL FROM THE ANASTOMOTIC INSTRUMENT (AI). THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE ISSUE COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT DURING A MANDIBULAR FLAP RECONSTRUCTION SURGERY, THE RING OF TWO (2) 2.5MM GEM COUPLERS DID NOT ENGAGE WITH THE HOLE IN THE MEETING RING. THEREFORE, THE PROCEDURE WAS CHANGED TO HAND SUTURING. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.