FDA Adverse Event
Malfunction
Summary report: N
GAP ENDO-EXO MEDULLAY SYSTEM
MDR report key: 4293766
·
Received July 31, 2014
Report
- Report Number
- 3000327445-2014-00006
- Event Type
- Malfunction
- Date Received
- July 31, 2014
- Date of Event
- July 3, 2014
- Report Date
- July 3, 2014
- Manufacturer
- PEGA MEDICAL INC.
- Product Code
- HSB
- PMA / PMN Number
- 111232
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE NAIL DRIVER OF THE GAP ENDO-EXO MEDULLARY SYSTEM BROKE DURING THE NAIL INSERTION. THE SURGERY WAS COMPLETED WHEN THE DEVICE BREAKAGE WAS NOTICED. NO ADVERSE EVENTS, INJURIES OR DISABILITY OCCURRED TO THE PATIENT DUE TO THE INSTRUMENT BREAKAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 449063 | GAP ENDO-EXO MEDULLAY SYSTEM | GAP NAIL | HSB | PEGA MEDICAL INC. | NAIL DRIVER | 130102-010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 6 YR | Other |