TAP FOR RECON SCREWS / Ø 6.5MM

Additional Manufacturer Narrative

PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. H11 ADDITIONAL NARRATIVE: D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT WHEN UTILIZING THE ANS BASE INSTRUMENT SET AND THE TFNA STANDARD SETS, THEY HAD NUMEROUS ITEMS BREAK/BECOME FAULTY THAT DELAYED OUT SURGERY SUBSTANTIALLY. THESE ITEMS WERE NOT WORKING PROPERLY/BREAKING DURING THE PROCEDURE CAUSED ROUGHLY A 15 MINUTES DELAY WITH THE PROCEDURE, AND HAD TO BE REMOVED FROM SERVICE. NO FRAGMENTS WERE LEFT INSIDE THE PATIENT, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THEY HAD TO TAKE ROUGHLY 10-15 SECONDS ADDITIONAL OF FLUOROSCOPY TO ASSIST WITH THIS.