FDA Adverse Event
Malfunction
Summary report: Y
MAESTRO AIR MOTOR
MDR report key: 21201039
·
Received January 21, 2025
Report
- Report Number
- 3015967359-2025-00213
- Event Type
- Malfunction
- Date Received
- January 21, 2025
- Date of Event
- December 31, 2024
- Report Date
- January 21, 2025
- Manufacturer
- STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
- Product Code
- HBB
- UDI-DI
- 07613327096460
- 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: 18 EVENTS WERE REPORTED FOR THIS QUARTER. PRODUCT RETURN STATUS: 18 DEVICES WERE RECEIVED. ADDITIONAL INFORMATION: 18 DEVICES WERE NOT LABELED FOR SINGLE-USE. 18 DEVICES WERE NOT REPROCESSED OR REUSED.
Description of Event or Problem · 0
THIS REPORT SUMMARIZES 18 MALFUNCTION EVENTS IN WHICH THE DEVICE WAS REPORTEDLY LEAKING. - 17 EVENTS HAD THE PROBLEM IDENTIFIED DURING A NON-CLINICAL PROCEDURE; THERE WAS NO PATIENT INVOLVEMENT. - 1 EVENT HAD THE PROBLEM IDENTIFIED BEFORE CLINICAL USE/EXPOSURE; THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 663092 | MAESTRO AIR MOTOR | MOTOR, DRILL, PNEUMATIC | HBB | STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP | 07613327096460 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |