A&E MEDICAL / ROTATING SURGICAL PUNCHES RSP 4.0MM 6BOX ST
Received Apr 4, 2025 · Event occurred Mar 7, 2025
Report 0002242056-2025-00005 · MDR key 21772842
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 FOLLOWING SECTIONS WERE UPDATED: B4; B5; D2; G1; G3; G6; H1; H2; H3; H6. 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.
Description of Event or Problem
IT WAS REPORTED THAT DURING A CARDIAC SURGERY (CABG) PROCEDURE, A SCRUB NURSE TESTED THE ROTATING SURGICAL PUNCH DURING TABLE SETUP, AND SEVERAL SMALL, BLACK-COLORED FRAGMENTS OF PLASTIC FELL OUT 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.
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.
Additional Manufacturer Narrative
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
Description of Event or Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.