4.0MM ROTATING SURGICAL PUNCH - FLAT TIP
Received Jun 4, 2025 · Event occurred May 8, 2025
Report 0002242056-2025-00030 · MDR key 22143715
Device
Product problems
- Packaging Problem
- Packaging Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
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 OF THE PRODUCTS; FOREIGN OBJECTS WERE FOUND WITHIN THE STERILE PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.
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; H5; H6; H10. THE REPORTED EVENT WAS CONFIRMED BY A REVIEW OF PICTURES. NO PRODUCT WAS RETURNED. A VISUAL VERIFICATION OF THE PROVIDED PHOTO(S) IDENTIFIED THE ITEM PACKAGED WITH DEBRIS THAT APPEARS WITHIN STERILE PACKAGING. THE DEVICE HISTORY RECORD WAS REVIEWED, AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. THE ROOT CAUSE HAS BEEN IDENTIFIED AS A MANUFACTURING 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.
Description of Event or Problem
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.