RSP 4.0MM 6BOX ST
Received Jul 24, 2023 · Event occurred Jun 28, 2023
Report 0002242056-2023-00023 · MDR key 17379732
Device
Generic name
Aorta Punch, Single-use
Manufacturer
A&e Medical CorporationModel number
NICatalog number
080-401
Lot number
09419
Product problems
- Dull, Blunt
- Dull, Blunt
Patient
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
A VISUAL INSPECTION WAS CONDUCTED ON THE RETURNED PUNCH. THE PUNCH WAS RETURNED OUTSIDE OF THE PACKAGING AND SHOWED SIGNS OF ATTEMPTED USE INCLUDING DEBRIS ON THE TIP CUTTING SURFACE. THE PLUNGER WAS PULLED BACK AND THE CUTTING TIP FULLY RETRACTED INTO THE PUNCH BODY. THE CUTTING ACTION APPEARS TO BE WORKING AS IT SHOULD. THE CAP FOR THE PUNCH WAS FULLY SEATED WHEN RECEIVED. THE CAP WAS REMOVED AND RE-INSTALLED AND LOCKED IN PLACE AS DESIGNED. THE COMPLAINT IS UNABLE TO BE CONFIRMED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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
IT WAS REPORTED THAT THE SURGICAL PUNCH WAS UNABLE TO CUT THROUGH TISSUE AS INTENDED AND ANOTHER PUNCH WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.
Additional Manufacturer Narrative
(B)(4) G2: 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.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4, B5, D4,G3, G6, H2, H3, H4, H6, H10 -NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. -REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. -A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. THE REPORTED EVENT CANNOT BE CONFIRMED. 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.