ARM 1362275 UNIVERSAL FLEXIBLE

Additional Manufacturer Narrative

AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem

THIS 3 OF 3 REPORTS LINKED TO MFG REPORT NUMBERS: 3014334038-2022-00049, 3014334038-2022-00048. A FACILITY REPORTED THAT THE UNIVERSAL FLEXIBLE ARM (1362275) BROKE IN THE MIDDLE OF A TYMPANOPLASTY PROCEDURE. ALL PARTS WERE RECOVERED AND WERE TAKEN OFF THE SURGICAL FIELD; NO FRAGMENTS FELL INTO THE SURGICAL SITE. IT WAS REPORTED THAT AN X-RAY WAS PERFORMED TO ASSURE THAT NO PARTS WERE LEFT IN THE PATIENT FOLLOWING THE EVENT. THE EVENT DID NOT LEAD TO PATIENT INJURY, DEATH, OR DELAY IN PROCEDURE.

Description of Event or Problem

N/A

Additional Manufacturer Narrative

UPDATED FIELDS:  D4, D9, G3, G6, H2, H3, H4, H10. THE UNIVERSAL FLEXIBLE ARM (1362275) WAS RETURNED FOR EVALUATION: FAILURE ANALYSIS & ROOT CAUSE - THE REPORTED COMPLAINT IS CONFIRMED. THE RETURNED 1362275 UNIVERSAL FLEXIBLE ARM IS IN USED CONDITION WITH THE TIP BROKEN OFF DUE TO INSUFFICIENT SOLDERING AND EXCESS TIGHTENING FORCE AT THE END OF THE ARM. SUPPLIER CORRECTIVE ACTION HAS BEEN INITIATED FOR THIS ISSUE, AND A RECALL WAS INITIATED FOR THIS PRODUCT ISSUE.