OPTIPAC 60 REFOBACIN BN CMT R ENT R
Report
- Report Number
- 3006946279-2019-00050
- Event Type
- Malfunction
- Date Received
- January 17, 2019
- Date of Event
- December 19, 2018
- Report Date
- July 18, 2019
- Manufacturer
- BIOMET FRANCE S.A.R.L.
- Product Code
- MBB
- PMA / PMN Number
- K150850
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE RETURNED ITEM HAS BEEN INSPECTED. THE EVALUATION SHOWED THAT THE TWO POUCHES WERE PUNCTURED BY CANNULA AND PARTIALLY EMPTY. THE VACUUM TEST WAS PERFORMED AND THE SYSTEM WAS NOT TIGHT. THE DOCUMENTARY REVIEW SHOWED THAT PRODUCTS WERE MANUFACTURED ACCORDING TO THE PRE-DEFINED SPECIFICATIONS OF BIOMET FRANCE. WITH THE AVAILABLE INFORMATION, THE EXACT ROOT CAUSE OF THE EVENT COULD NOT 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.
(B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
(B)(4) THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. AN INVESTIGATION HAS BEEN PERFORMED, CONSISTING OF A DOCUMENTARY REVIEW AND A PRODUCT ANALYSIS. THE DOCUMENTARY REVIEW SHOWED THAT PRODUCTS WERE MANUFACTURED ACCORDING TO THE PRE-DEFINED SPECIFICATIONS OF BIOMET FRANCE. THE RETURNED ITEM HAS BEEN INSPECTED AND THE VACCUM WAS NOT TIGHT BUT NO NON CONFORMITY WAS DETECTED ON THE PRODUCT. THE ROOT CAUSE COULD NOT 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.
IT HAS BEEN REPORTED THAT THE NURSE TRIED MIXING THE CEMENT WHEN THE LIQUID DID NOT WANT TO MOVE INTO THE SYRINGE.
IT HAS BEEN REPORTED THAT THE NURSE TRIED MIXING THE CEMENT WHEN THE LIQUID DID NOT WANT TO MOVE INTO THE SYRINGE.
IT HAS BEEN REPORTED THAT THE NURSE TRIED MIXING THE CEMENT WHEN THE LIQUID DID NOT WANT TO MOVE INTO THE SYRINGE.
(B)(4). UNIQUE IDENTIFIER (UDI) # :(B)(4). REPORT SOURCE, FOREIGN - EVENT OCCURRED IN (B)(6). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.
IT HAS BEEN REPORTED THAT THE LIQUID IS NOT ENTERING THE SYRINGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 49429 | OPTIPAC 60 REFOBACIN BN CMT R ENT R | BONE CEMENT, ANTIBIOTIC | MBB | BIOMET FRANCE S.A.R.L. | A715A08935 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |