FDA Adverse Event
Malfunction
Summary report: N
BRASSELER USA DRILL BIT
MDR report key: 3266863
·
Received April 16, 2013
Report
- Report Number
- 2025102-2013-00002
- Event Type
- Malfunction
- Date Received
- April 16, 2013
- Date of Event
- September 28, 2012
- Report Date
- April 16, 2013
- Manufacturer
- BRASSELER USA, MEDICAL L.L.C.
- Product Code
- HTW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
NO PRODUCT RETURNED. HOSPITAL WAS CONTACTED SEVERAL TIMES TO OBTAIN PATIENT AND PRODUCT INFORMATION. NO INFORMATION WAS PROVIDED.
Description of Event or Problem · 1
PER MAUDE EVENT REPORT: PATIENT WITH HISTORY OF RHEUMATOID ARTHRITIS AND DEGENERATIVE JOINT DISEASE UNDERWENT A RIGHT TOTAL SHOULDER ARTHROPLASTY. THE TIP OF A 2.5MM DRILL BIT BROKE OFF DURING THE PROCEDURE. IT WAS FLUOROSCOPICALLY IDENTIFIED AND IMMEDIATELY REMOVED. NO FURTHER INFORMATION PROVIDED BY THE HOSPITAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 164170 | BRASSELER USA DRILL BIT | DRILL BIT | HTW | BRASSELER USA, MEDICAL L.L.C. | KM166-310-23 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |