SIMPLEX TOBRAMYCIN 1 PK
Report
- Report Number
- 0002249697-2020-00218
- Event Type
- Malfunction
- Date Received
- February 4, 2020
- Date of Event
- January 3, 2020
- Report Date
- January 25, 2023
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- LOD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HK
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
REPORTED EVENT: AN EVENT REGARDING DAMAGE (MATERIAL FRAGMENTS) INVOLVING A SIMPLEX AMPOULE WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: PRODUCT EVALUATION AND RESULTS: THE REPORTED DEVICE WAS NOT RETURNED HOWEVER PHOTOGRAPHS WERE PROVIDED FOR REVIEW. THE PHOTOGRAPHS NOTE THE FOLLOWING:THE PICTURE DISPLAYED A USED SIMPLEX AMPOULE WITH THE OPENED CAP BY THE SIDE. THE EDGE OF THE OPENING AREA APPEARS TO BE SMOOTH WITH NOTHING REMARKABLE TO REPORT. MEDICAL RECORDS RECEIVED AND EVALUATION: NO MEDICAL RECORDS WERE RECEIVED FOR REVIEW WITH A CLINICAL CONSULTANT. PRODUCT HISTORY REVIEW: A REVIEW OF THE DEVICE MANUFACTURING RECORDS INDICATE THAT ALL DEVICES ACCEPTED INTO FINAL STOCK WERE FREE FROM DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: THE PHOTOGRAPHS NOTE THE FOLLOWING:THE PICTURE DISPLAYED A USED SIMPLEX AMPOULE WITH THE OPENED CAP BY THE SIDE. THE EDGE OF THE OPENING AREA APPEARS TO BE SMOOTH WITH NOTHING REMARKABLE TO REPORT. THE REPORTED EVENT COULD NOT BE CONFIRMED AND THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. IF DEVICES AND / OR ADDITIONAL INFORMATION BECOME AVAILABLE TO INDICATE FURTHER EVALUATION IS WARRANTED, THIS RECORD WILL BE REOPENED.
D3 LEGAL MANUFACTURER WAS SELECTED AS STANMORE IMPLANTS WORLDWIDE IN ERROR. THIS SUPPLEMENTAL IS BEING SENT TO CORRECT D3 TO STRYKER ORTHOPAEDICS-MAHWAH.
AS MENTIONED, WE RECENTLY AWARE OF SEVERAL INCIDENTS ( I WITNESSED ONE AT TKOH TODAY AND PWH REPORTED A FEW INCIDENTS IN DEC) THAT OUR TOBRA CEMENT AMPULE BROKEN INTO SMALL PIECES WHEN THE SCRUB NURSES TRIED TO OPEN IT. TKOH DIDN¿T COMPLAIN BUT I HAVE ATTACHED THE CEMENT LOG FOR YOUR REFERENCE. PWH DIDN¿T KEEP THE CEMENT LABEL SO I COULDNT SEND TO YOU FOR CHECKING. UPDATE: "TYPE OF PROCEDURE BEING PERFORMED: TKOH - TKR TRIATHLON. THERE WAS A SURGICAL DELAY OF APPROX 2 MINUTES AS NEW PACK OF CEMENT NEEDED TO BE OPENED.
AS MENTIONED, WE RECENTLY AWARE OF SEVERAL INCIDENTS ( I WITNESSED ONE AT TKOH TODAY AND PWH REPORTED A FEW INCIDENTS IN (B)(6)) THAT OUR TOBRA CEMENT AMPULE BROKEN INTO SMALL PIECES WHEN THE SCRUB NURSES TRIED TO OPEN IT. TKOH DIDN¿T COMPLAIN BUT I HAVE ATTACHED THE CEMENT LOG FOR YOUR REFERENCE. PWH DIDN¿T KEEP THE CEMENT LABEL SO I COULDNT SEND TO YOU FOR CHECKING. UPDATE: "TYPE OF PROCEDURE BEING PERFORMED: TKOH - TKR TRIATHLON. THERE WAS A SURGICAL DELAY OF APPROX 2 MINUTES AS NEW PACK OF CEMENT NEEDED TO BE OPENED.
REVIEW OF THE DEVICE HISTORY RECORDS INDICATE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO RELEVANT REPORTED DISCREPANCIES. THERE HAVE BEEN NO OTHER SIMILAR EVENTS FOR THE LOT REFERENCED. IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.
AS MENTIONED, WE RECENTLY AWARE OF SEVERAL INCIDENTS ( I WITNESSED ONE AT TKOH TODAY AND PWH REPORTED A FEW INCIDENTS IN DEC) THAT OUR TOBRA CEMENT AMPULE BROKEN INTO SMALL PIECES WHEN THE SCRUB NURSES TRIED TO OPEN IT. TKOH DIDN¿T COMPLAIN BUT I HAVE ATTACHED THE CEMENT LOG FOR YOUR REFERENCE. PWH DIDN¿T KEEP THE CEMENT LABEL SO I COULDNT SEND TO YOU FOR CHECKING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 126660 | SIMPLEX TOBRAMYCIN 1 PK | BONE CEMENT | LOD | STRYKER ORTHOPAEDICS-MAHWAH | TDA022 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |