OXF UNI TIB TRAY SZ C RM PMA
Report
- Report Number
- 3002806535-2018-00793
- Event Type
- Malfunction
- Date Received
- May 10, 2018
- Date of Event
- October 12, 2016
- Report Date
- November 8, 2018
- Manufacturer
- BIOMET UK LTD.
- Product Code
- NRA
- PMA / PMN Number
- N/A
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4). PRODUCT WAS RETURNED TO THE MANUFACTURER, BIOMET ORTHOPEDICS LLC FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED PACKAGING DETERMINED THAT THE SHRINK WRAP AND OUTER CARTON HAVE BEEN OPENED AND THE TYVEK LID HAS BEEN PEELED OFF OF THE BLISTER CAVITY. THE CAVITY FLANGE SHOWS UNIFORM EVIDENCE OF ADHESIVE TRANSFER AROUND THE FULL WIDTH. THE INNER POUCH WAS ALSO FOUND TO BE OPENED AND APPEARS TO HAVE BEEN TORN OR CUT OPEN. THE DEVICE HISTORY RECORDS FOR 154723, LOT 046960 WERE REVIEWED FOR DEVIATIONS AND/OR ANOMALIES WITH THE FOLLOWING DEVIATIONS/ANOMALIES IDENTIFIED: 1 PIECE SCRAPPED AT (B)(4) POLISH COMPLETE. REVIEW OF THE FINAL INSPECTION CRITERIA FOR PACKAGING AND LABELING IN PLACE AT THE TIME OF MANUFACTURE, DETERMINED THAT 100% OF THE STERILE PACKAGING IS INSPECTED FOR SEAL WIDTH AND INTEGRITY PRIOR TO RELEASE. REVIEW OF THE PRODUCT CONFIRMS THAT THE PRODUCT WAS OPENED HOWEVER IT CANNOT BE VERIFIED IF THE PRODUCT WAS OPENED PRIOR TO THE CUSTOMER RECEIVING IT AS THE CONDITION OF THE RETURNED POUCH AND BLISTER INDICATES THAT THE PRODUCT WAS FULLY SEALED AND THE INNER POUCH WAS TORN OR CUT OPEN. THE PRODUCT WAS LIKELY CONFORMING WHEN IT WAS RELEASED FROM ZIMMER BIOMET CONTROL. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY.
(B)(4). PRODUCT WAS RETURNED TO THE MANUFACTURER, BIOMET ORTHOPEDICS LLC FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED PACKAGING DETERMINED THAT THE SHRINK WRAP AND OUTER CARTON HAVE BEEN OPENED AND THE TYVEK LID HAS BEEN PEELED OFF OF THE BLISTER CAVITY. THE CAVITY FLANGE SHOWS UNIFORM EVIDENCE OF ADHESIVE TRANSFER AROUND THE FULL WIDTH. THE INNER POUCH WAS ALSO FOUND TO BE OPENED AND APPEARS TO HAVE BEEN TORN OR CUT OPEN. THE DEVICE HISTORY RECORDS FOR 154723, LOT 046960 WERE REVIEWED FOR DEVIATIONS AND/OR ANOMALIES WITH THE FOLLOWING DEVIATIONS/ANOMALIES IDENTIFIED: 1 PIECE SCRAPPED AT (B)(4) POLISH COMPLETE. REVIEW OF THE FINAL INSPECTION CRITERIA FOR PACKAGING AND LABELING IN PLACE AT THE TIME OF MANUFACTURE, DETERMINED THAT 100% OF THE STERILE PACKAGING IS INSPECTED FOR SEAL WIDTH AND INTEGRITY PRIOR TO RELEASE. REVIEW OF THE PRODUCT CONFIRMS THAT THE PRODUCT WAS OPENED HOWEVER IT CANNOT BE VERIFIED IF THE PRODUCT WAS OPENED PRIOR TO THE CUSTOMER RECEIVING IT AS THE CONDITION OF THE RETURNED POUCH AND BLISTER INDICATES THAT THE PRODUCT WAS FULLY SEALED AND THE INNER POUCH WAS TORN OR CUT OPEN. THE PRODUCT WAS LIKELY CONFORMING WHEN IT WAS RELEASED FROM ZIMMER BIOMET CONTROL. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY.
INNER STERILE PACKAGING WAS COMPROMISED.
INNER STERILE PACKAGING WAS COMPROMISED.
(B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
IT WAS REPORTED THAT OUTER BOX WAS OPENED AND THE INNER STERILE PACKAGING WAS COMPROMISED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 348068 | OXF UNI TIB TRAY SZ C RM PMA | NRA | BIOMET UK LTD. | N/A | 046960 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR |