STERNAL ZIPFIX WITH NEEDLE STERILE/20 PACK
Received May 2, 2025 · Event occurred Apr 2, 2025
Report 8030965-2025-04430 · MDR key 21949858
Device
Product problems
- Break
- Break
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
ADDITIONAL INFORMATION HAS BEEN RECEIVED, THE PREVIOUSLY REPORTED EVENT UNDER MRN 8030965-2025-04430 AND 8030965-2025-04431 ARE NO LONGER CONSIDERED REPORTABLE AT THIS TIME AS THERE WAS NO FAILURE OF THE DEVICE. NO FURTHER FOLLOW-UPS WILL BE SENT UNDER MRN 8030965-2025-04430 AND 8030965-2025-04431.
Description of Event or Problem
IT WAS REPORTED THAT A ZIPFIX BAND OPENED AFTER BEING TIGHTENED BY THE SURGEON. THIS BAND WAS USED. TWO OTHER BANDS FROM SAME BATCH WERE BROKEN.
Additional Manufacturer Narrative
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.