RSP 4.0MM 6BOX ST
Received Mar 25, 2025 · Event occurred Jan 10, 2025
Report 0002242056-2025-00003 · MDR key 21687507
Device
Product problems
- Manufacturing, Packaging or Shipping Problem
- Manufacturing, Packaging or Shipping Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT WHILE SETTING UP FOR A PROCEDURE, THE SCRUB NURSE TESTED THE PUNCH AS IS PROCEDURE FOR THE FACILITY. WHEN TESTING THE DEVICE, BY PUSHING PLUNGER IN AND OUT, 2 SMALL BLACK BITS FELL OUT OF PUNCH END OF DEVICE. THERE WAS NO PATIENT INJURY AND THE DEVICE WAS USED TO COMPLETE THE PROCEDURE.
Additional Manufacturer Narrative
COMPLAINT (B)(4). G2: FOREIGN SOURCE: CANADA. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
Description of Event or Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION AND/OR CORRECTED INFORMATION. UPDATED: D5, D9, H2, H3, H6 AND H11. D4 - ATTEMPTS HAVE BEEN MADE TO GATHER ALL PRODUCT IDENTIFICATION INFORMATION, AND NO FURTHER INFORMATION HAS BEEN PROVIDED. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. REVIEW OF THE SUPPLIED PHOTO SHOWS PRODUCT HAS BEEN OPENED AND IS OUTSIDE OF THE ORIGINAL PACKAGING. IN THE PICTURE THERE IS A PUNCH, AND A SMALL PIECE OF BLACK DEBRIS CAN BE SEEN WITHIN A TEGADERM DRESSING. PRODUCT WAS RETURNED AND A VISUAL INSPECTION WAS CONDUCTED ON THE RETURNED PUNCH AND DEBRIS. LOT NUMBER COULD NOT BE IDENTIFIED. THE PRODUCT HAS BEEN OPENED, AND IT IS OUTSIDE OF THE ORIGINAL PACKAGING. TWO BLACK PIECES OF DEBRIS WERE RETURNED WITHIN A TEGADERM DRESSING. AN FTIR ANALYSIS WAS CONDUCTED ON THE DEBRIS. THE SPECTRA PRODUCED FROM THE UNKNOWN MATERIAL SAMPLES COULD NOT BE CONCLUSIVELY IDENTIFIED. THE SPECTRA PRODUCED FROM THE UNKNOWN MATERIAL SAMPLES WERE MOST CONSISTENT WITH ACRYLIC MATERIALS. THE SPECTRA PRODUCED FROM THE UNKNOWN MATERIAL SAMPLES WERE COMPARED TO PREVIOUS TESTING AND THE TESTING FOR THESE RETURNED SAMPLES SHARED SOME OF THE MAJOR PEAKS WITH THE SPECTRA RECORDED. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.