RSP 4.0MM 6BOX ST
Received Nov 26, 2025 · Event occurred Oct 31, 2025
Report 0002242056-2025-00043 · MDR key 23656576
Device
Product problems
- Device Contaminated During Manufacture or Shipping
- Device Contaminated During Manufacture or Shipping
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
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. THE FOLLOWING SECTIONS WERE UPDATED: H4; H6; H11 THE REPORTED EVENT WAS CONFIRMED BY REVIEW OF PICTURES. VISUAL EVALUATION OF THE PROVIDED PHOTO FOUND UNKNOWN DEBRIS IN THE VENDOR SEAL AREA OF THE POUCH. THE PHOTO DOES NOT DEPICT IF THE DEBRIS INTERFERES WITH THE POUCH SEAL. FURTHER EVALUATION OF THE PRODUCT IS NEEDED TO DETERMINE THE CONFORMANCE OF THE POUCH SEAL. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE HAS BEEN IDENTIFIED AS A PACKAGING ISSUE. 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.
Additional Manufacturer Narrative
(B)(4). G2 - REPORT SOURCE - FOREIGN - TAIWAN. 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
IT WAS REPORTED DURING INSPECTION AT THE DISTRIBUTORSHIP THAT THE DEVICE'S INNER PACKAGING HAD A STAIN. THERE WAS NO PATIENT INVOLVEMENT.