FDA Adverse Event
Injury
Summary report: N
AO
MDR report key: 109567
·
Received July 3, 1997
Report
- Report Number
- 109567
- Event Type
- Injury
- Date Received
- July 3, 1997
- Date of Event
- May 1, 1997
- Report Date
- May 9, 1997
- Manufacturer
- AO-SYNTHES
- Product Code
- HTW
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
AIR COMPACT AIR TRIGGER STICKING RESULTING IN ADVERSE PT EVENT. 1) LOSS OF REDUCTION, 2) NEED FOR 2ND PROCEDURE, 3) FRACTURE OF 2ND/3RD METATARSAL. (1ST & 2ND DRILL USED HAD STICKING TRIGGER)
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AO | COMPACT AIR DRILL | HTW | AO-SYNTHES | * | * | |
| 2 | AO | COMPACT AIR DRILL | HTW | SNTHES | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Required Intervention |