FDA Adverse Event
Malfunction
Summary report: Y
ACM KIT W/ FEMORAL BREAKAWAY NOZZLE
MDR report key: 16261953
·
Received January 29, 2023
Report
- Report Number
- 3015967359-2023-00226
- Event Type
- Malfunction
- Date Received
- January 29, 2023
- Date of Event
- December 31, 2022
- Report Date
- January 29, 2023
- Manufacturer
- STRYKER INSTRUMENTS-PUERTO RICO
- Product Code
- JDZ
- UDI-DI
- 34546540055409
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. REPORTED EVENTS: 2 EVENTS WERE REPORTED FOR THIS QUARTER. PRODUCT RETURN STATUS: 1 DEVICE WAS RECEIVED. 1 DEVICE WAS NOT AVAILABLE FOR EVALUATION. ADDITIONAL INFORMATION: 2 DEVICES WERE LABELED FOR SINGLE-USE. 2 DEVICES WERE NOT REPROCESSED OR REUSED.
Description of Event or Problem · 0
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS IN WHICH THE DEVICE HAD DEBRIS IN STERILE PACKAGE. 2 EVENTS HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 15162 | ACM KIT W/ FEMORAL BREAKAWAY NOZZLE | MIXER, CEMENT, FOR CLINICAL USE | JDZ | STRYKER INSTRUMENTS-PUERTO RICO | VMSR | 34546540055409 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |