RSP 4.0MM 6BOX ST
Received Dec 18, 2023 · Event occurred Nov 24, 2023
Report 0002242056-2023-00034 · MDR key 18345560
Device
Generic name
Punch, Surgical
Manufacturer
A&e Medical CorporationModel number
N/ACatalog number
080-401
Lot number
11164
Product problems
- Packaging Problem
- Packaging Problem
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 IS AVAILABLE AT THE TIME OF THIS REPORT.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REVIEW OF SUPPLIED PHOTO SHOWS ROTATING SURGICAL PUNCH OUT OF PACKAGING, AS WELL AS A DARK COLORED ITEM. IT CANNOT BE DETERMINED BY THIS PHOTO WHAT THE DARK COLORED ITEM MAY BE. RETURNED SPECIMEN WAS DISCARDED PRIOR TO REVIEW BEING PERFORMED BY THE PMS TEAM. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. 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
ZIMMER BIOMET COMPLAINT (B)(4). G3: FOREIGN SOURCE: CANADA. 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 THAT WHILE THE PUNCH WAS BEING TESTED DURING SETUP, A VERY SMALL DARK-COLORED ITEM FELL OUT OF THE PUNCH. NO HARM OR INJURY WAS REPORTED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT PUNCH.