A&E MEDICAL / ROTATING SURGICAL PUNCHES
Received Feb 5, 2025
Report 0002242056-2025-00001 · MDR key 21313487
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
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; H4; H6. THE REPORTED EVENT IS CONFIRMED. NO PRODUCT WAS RETURNED. A VISUAL INSPECTION WAS CONDUCTED ON THE CUSTOMER PROVIDED PICTURE. THE PICTURE SHOWS A ZOOMED-IN VIEW OF THE PRODUCT PACKAGING. THE PICTURE SHOWS SEVERAL SMALL PIECES OF DEBRIS. HOWEVER, BASED ON THE PICTURES, IT CANNOT BE DETERMINED WHAT THE DEBRIS IS, OR IF THE DEBRIS IS ALSO INSIDE OR OUTSIDE OF THE PACKAGING. FROM THE PICTURE, IT ALSO CANNOT BE DETERMINED IF THE PRODUCT PACKAGING HAS BEEN OPENED OR IS SEALED. A REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. THE REPORTED EVENT DID NOT OCCUR IN AN OPERATING ROOM OR AS PART OF A MEDICAL PROCEDURE; MEDICAL RECORDS ARE NOT AVAILABLE FOR REVIEW. THE LIKELY CONDITION OF THE DEVICE WHEN IT LEFT ZIMMER BIOMET CONTROL IS CONSIDERED NONCONFORMING BASED ON THE EVALUATION OF THE PROVIDED PICTURES. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO A MANUFACTURING 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.
Description of Event or Problem
IT WAS REPORTED BY THE DISTRIBUTORSHIP THAT THE PRODUCTS WERE FOUND TO BE NONCONFORMING, AND A FOREIGN SUBSTANCE WAS PRESENT WITHIN THE STERILE PACKAGING. NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Additional Manufacturer Narrative
(B)(4). G2: FOREIGN - THE EVENT OCCURRED IN JAPAN. 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.