COUPLER

Additional Manufacturer Narrative

H10: THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED WHICH OBSERVED SIGNS OF USE (DRIED BLOOD). FURTHER INSPECTION DID SHOW A BENT PIN VISIBLE ON THE 1.5MM COUPLER RINGS.THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED, HOWEVER, THERE IS THE POTENTIAL THAT THE PIN COULD BE BENT DURING REMOVAL OF THE WHITE PROTECTIVE HOLDER, DURING PREPARATION FOR OR IN THE BEGINNING STAGES OF THE SURGICAL PROCESS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

UPDATE MADE TO D4: LOT #: SP20I25-1478755 (PREVIOUSLY SUBMITTED AS ASKU). UPDATE MADE TO D4: UNIQUE IDENTIFIER (UDI) #: (B)(4) (PREVIOUSLY SUBMITTED AS NI). 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

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

Description of Event or Problem

IT WAS REPORTED THAT THE PINS OF A 1.5MM COUPLER WERE BENT. THIS WAS IDENTIFIED BEFORE USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.