A&E MEDICAL / ROTATING SURGICAL PUNCHES
Received May 6, 2025 · Event occurred Apr 9, 2025
Report 0002242056-2025-00008 · MDR key 21966160
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
(B)(4). G2: FOREIGN - THE EVENT OCCURRED IN TAIWAN. 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 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
IT WAS REPORTED THAT A DISTRIBUTOR FOUND AN UNIDENTIFIED BLACK OBJECT IN THE PACKAGE DURING THEIR INSPECTION PROCESS. THERE WAS NO PATIENT INVOLVEMENT OR IMPACT AS IT WAS IDENTIFIED OUTSIDE OF A CLINICAL SETTING. THE DISTRIBUTOR APPLIED THE CORRECT SURGICAL TECHNIQUE WHEN INSPECTING THE PRODUCT PACKAGING. NO ADDITIONAL INFORMATION IS REQUIRED AT THIS TIME.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, G3, G6, H2, H3, H4, H6, H11. NO PRODUCT WAS RETURNED, OR PHOTOS PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. THE ROOT CAUSE OF THE REPORTED ISSUE IS ATTRIBUTED TO MANUFACTURING PROCESS. THE REPORTED EVENT IS UNCONFIRMED. IF ANY FURTHER INFORMATION IS FOUND WHICH 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
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.