A&E MEDICAL / ROTATING SURGICAL PUNCHES RSP 4.0MM 6BOX ST
Received Apr 4, 2025 · Event occurred Mar 6, 2025
Report 0002242056-2025-00006 · MDR key 21772847
Device
Product problems
- Contamination /Decontamination Problem
- Contamination /Decontamination Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE REPORTED EVENT IS UNCONFIRMED. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT 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.
Description of Event or Problem
NO FURTHER EVENT INFORMATION IS 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: H2, H3, H6 AND H11. COMPLAINT SAMPLE WAS EVALUATED, AND THE REPORTED EVENT WAS CONFIRMED. AN INVESTIGATION WAS CONDUCTED ON THE RETURNED PUNCH. THE PUNCH ARRIVED WITH THE PACKAGING OPENED. THE CUSTOMER HAS STAPLED THE PACKAGING BACK TOGETHER. INCLUDED WITH THE PACKAGING WAS A SINGLE PIECE OF BLACK DEBRIS, SECURED INSIDE OF A FOLDED PIECE OF TAPE. THE DEBRIS WAS SENT OFF FOR ATS TESTING. AN ANALYSIS WAS UNABLE TO BE CONDUCTED HOWEVER AS IT WAS NOT POSSIBLE TO SEPARATE/ ISOLATE THE DEBRIS FROM THE PACKAGING. A DETERMINATION AS TO WHERE THE DEBRIS CAME FROM IS UNABLE TO BE MADE AS THE PACKAGING WAS OPENED IN THE FIELD AND AN ANALYSIS COULD NOT BE CONDUCTED ON THE MATERIAL. ROOT CAUSE ATTRIBUTED TO MANUFACTURING PACKAGING ISSUE. A CORRECTIVE ACTION WAS INITIATED A RESULT OF THE MALFUNCTION. 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.
Description of Event or Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Additional Manufacturer Narrative
(B)(4). G2: FOREIGN - THE EVENT OCCURRED IN CANADA. THE CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN THE PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND THAT WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.
Description of Event or Problem
IT WAS REPORTED THAT DURING A CARDIAC SURGERY (CABG) PROCEDURE, A ROTATING SURGICAL PUNCH WITH A FLAT TIP WAS TESTED DURING TABLE SETUP, AND A SMALL FRAGMENT OF PLASTIC FELL FROM THE END OF THE DEVICE. THIS ISSUE WAS IDENTIFIED BEFORE PATIENT USE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. NO ADDITIONAL COMPLICATIONS WERE REPORTED. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.