COUPLER

Description of Event or Problem

IT WAS REPORTED THAT THE PINS OF A 2.5MM COUPLER WERE BENT; FURTHER DESCRIBED AS ¿RINGS WERE SITTING TOGETHER FROM ONE SIDE, AND THE PINS WERE BENT¿. THIS WAS IDENTIFIED WHEN THE DEVICE WAS TAKEN OUT OF THE PACKAGING. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

E1: INITIAL REPORTER ADDRESS: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

CORRECTION MADE TO D4: LOT #: SP21A20-1500931 (PREVIOUSLY SUBMITTED AS ASKU). ADDITIONAL INFORMATION WAS ADDED TO H6, H10: H6: TYPE OF INVESTIGATION: B14 WAS ADDED TO CAPTURE THE BATCH REVIEW. H10: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

H10: THE DEVICE WAS RECEIVED FOR EVALUATION. NO SIGNS OF USE WERE VISIBLE. VISUAL INSPECTION OF THE RETURNED SAMPLE REVEALED BOTH 2.5MM COUPLER RINGS WERE PRESENT IN THE JAW ASSEMBLY. FURTHER INVESTIGATION INTO THE RETURNED PRODUCT SHOWED A BENT PIN VISIBLE ON THE COUPLER RING. THE ALLEGATION OF ONE RING WAS MISSING FROM THE JAW ASSEMBLY WAS NOT VERIFIED, HOWEVER, THE REPORTED CONDITION OF A BENT PIN WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED; HOWEVER, THERE IS POTENTIAL THAT THE PIN COULD BE BENT DURING REMOVAL OF THE WHITE PROTECTIVE HOLDER OR DURING PREPARATION FOR USE IN THE BEGINNING STAGES OF THE SURGICAL PROCESS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.