FDA Adverse Event
Injury
Summary report: N
PF PINS
MDR report key: 3203550
·
Received July 3, 2013
Report
- Report Number
- 1020279-2013-00342
- Event Type
- Injury
- Date Received
- July 3, 2013
- Date of Event
- May 7, 2013
- Report Date
- June 11, 2013
- Manufacturer
- SMITH & NEPHEW, INC.
- Product Code
- JDW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
REPORTED ON UF/IMPORTER REPORT # (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING SURGERY THE PIN BROKE INTO TWO PIECES AND ONE PORTION WAS LEFT IN THE PATIENT'S BONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 304080 | PF PINS | 3.5MM PF PIN 40MM | JDW | SMITH & NEPHEW, INC. | 12FM07913 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Hospitalization| R |