RSP 4.5MM 6BOX ST
Received Aug 31, 2022
Report 0002242056-2022-00006 · MDR key 15330276
Device
Generic name
Aorta Punch, Single-use
Manufacturer
A&e Medical CorporationModel number
NICatalog number
080-451
Lot number
05038
Product problems
- Packaging Problem
- Packaging Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
(B)(4). COMMON DEVICE NAME: LRY. VISUAL EXAMINATION OF THE PROVIDED PHOTO IDENTIFIED THAT A HAIR IS WITHIN THE STERILE PACKAGING SEAL AND INNER PRODUCT CAVITY. NO PRODUCT WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORD(S) IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. THE CONDITION OF THE DEVICE WHEN IT LEFT ZIMMER BIOMET IS NON-CONFORMING TO SPECIFICATION. THE ROOT CAUSE OF THE REPORTED EVENT IS THE OPERATOR NOT FOLLOWING THE WORK INSTRUCTIONS PROVIDED. 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 A HAIR WAS FOUND INSIDE THE STERILE PACKAGE OUTSIDE OF A SURGICAL ENVIRONMENT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.