UNKNOWN_INSTRUMENTSTIRE_PRODUCT
Report
- Report Number
- 3015967359-2021-01240
- Event Type
- Malfunction
- Date Received
- June 24, 2021
- Date of Event
- February 1, 2021
- Report Date
- August 20, 2021
- Manufacturer
- STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP
- Product Code
- HBE
- PMA / PMN Number
- UNKNOWN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
H1: WAS REPORTED ON THE INITIAL AS A PRODUCT PROBLEM, CORRECTED TO ADVERSE EVENT AND PRODUCT PROBLEM. H6: THE QUALITY INVESTIGATION IS COMPLETE. H3 OTHER TEXT: DEVICE NOT RETURNED.
A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE. DEVICE NOT RETURNED.
IT WAS REPORTED VIA MEDWATCH MW 5101092 THAT DURING AN ORIF (OPEN REDUCTION AND INTERNAL FIXATION) SURGICAL PROCEDURE, THE DRILL BIT BROKE WHILE SURGEON WAS ACTIVELY DRILLING. IT WAS ALSO REPORTED THAT THE BROKEN DRILL BIT PIECE WAS LODGED INTO THE PATIENT¿S BONE. IT WAS FURTHER REPORTED THAT THE SURGEON WAS ABLE TO EXTRACT THE BROKEN PIECE, AN X-RAY CONFIRMED SUCCESSFUL REMOVAL.
IT WAS REPORTED VIA MEDWATCH MW 5101092 THAT DURING AN ORIF (OPEN REDUCTION AND INTERNAL FIXATION) SURGICAL PROCEDURE, THE DRILL BIT BROKE WHILE SURGEON WAS ACTIVELY DRILLING. IT WAS ALSO REPORTED THAT THE BROKEN DRILL BIT PIECE WAS LODGED INTO THE PATIENT¿S BONE. IT WAS FURTHER REPORTED THAT THE SURGEON WAS ABLE TO EXTRACT THE BROKEN PIECE, AN X-RAY CONFIRMED SUCCESSFUL REMOVAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 958711 | UNKNOWN_INSTRUMENTSTIRE_PRODUCT | DRILLS, BURRS, TREPHINES & ACCESSORIES | HBE | STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | UNKNOWN SYSTEM 8 DRILL. |