FDA Adverse Event
Malfunction
Summary report: N
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
MDR report key: 10024168
·
Received May 5, 2020
Report
- Report Number
- 10024168
- Event Type
- Malfunction
- Date Received
- May 5, 2020
- Date of Event
- April 20, 2020
- Report Date
- April 23, 2020
- Manufacturer
- DEGEN MEDICAL
- Product Code
- LXH
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- NC
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
TIP OF SCREWDRIVER BROKE OFF INTO THE SCREWHEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 488562 | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | LXH | DEGEN MEDICAL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28105 DA |