REVOLUTION CEMENT GUN
Report
- Report Number
- 3015967359-2023-00138
- Event Type
- Malfunction
- Date Received
- January 29, 2023
- Date of Event
- December 31, 2022
- Report Date
- July 27, 2023
- Manufacturer
- STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
- Product Code
- JDZ
- UDI-DI
- 04546540437037
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. REPORTED EVENTS: 1 EVENT WAS REPORTED FOR THIS QUARTER. PRODUCT RETURN STATUS: 1 DEVICE INVESTIGATION TYPE HAS NOT YET BEEN DETERMINED. ADDITIONAL INFORMATION: 1 DEVICE WAS NOT LABELED FOR SINGLE-USE; 1 DEVICE WAS NOT REPROCESSED OR REUSED.
THIS RECORD IS A CONSOLIDATION OF RECORDS SUMMARIZED AS A PART OF THE FDA VOLUNTARY MALFUNCTION SUMMARY REPORTING PROGRAM. SUPPLEMENTAL RATIONALE 1 PREVIOUSLY REPORTED EVENT IS INCLUDED IN THIS FOLLOW-UP RECORD. PRODUCT RETURN STATUS 1 DEVICE WAS RECEIVED.
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE DISASSEMBLED AND WAS SHEDDING METAL DEBRIS. EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE DISASSEMBLED AND WAS SHEDDING METAL DEBRIS. 1 EVENT HAD NO PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 16006 | REVOLUTION CEMENT GUN | MIXER, CEMENT, FOR CLINICAL USE | JDZ | STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP | 0606600000 | 04546540437037 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |