5.0MM ROTATING SURGICAL PUNCH - FLAT TIP
Received Dec 5, 2023 · Event occurred Oct 19, 2023
Report 0002242056-2023-00031 · MDR key 18267041
Device
Generic name
Punch, Surgical
Manufacturer
A&e Medical CorporationModel number
N/ACatalog number
080-501
Lot number
10338
Product problems
- Contamination /Decontamination Problem
- Contamination /Decontamination 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 AVAILABLE AT THE TIME OF THIS REPORT.
Additional Manufacturer Narrative
THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: B4; B5; D1; D4; D8; D9; G3; G6; H1; H2; H3; H4; H6; H10. NO PRODUCT WAS RETURNED, OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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.
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: AORTIC PUNCH NOTED TO HAVE SMALL PIECE OF PLASTIC ON THE END AFTER THE PUNCH WAS TESTED DURING TABLE SET UP. PUNCH AND PLASTIC REMOVED FROM THE STERILE FIELD. THERE WAS NO PATIENT INJURY AS A RESULT OF THE MALFUNCTION. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.