FDA Adverse Event
Injury
Summary report: N
TWIST DRILL
MDR report key: 3252150
·
Received July 25, 2013
Report
- Report Number
- 9610905-2013-00029
- Event Type
- Injury
- Date Received
- July 25, 2013
- Date of Event
- March 23, 2013
- Report Date
- July 12, 2013
- Manufacturer
- KARL LEIBINGER MEDIZINTECHNIK GMBH U. CO. KG
- Product Code
- HTW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
PRODUCT DISCARDED BY DOCTOR. IF FURTHER INFO IS ACQUIRED THAT ADDS VALUE TO THE CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A F/U REPORT WILL BE SENT.
Description of Event or Problem · 1
A TROCAR WAS INTRODUCED TO REPAIR AN OPEN FRACTURE OF THE RIGHT MANDIBLE, THE TWIST DRILL FRACTURED WHILE PLACING ONE OF THE SCREWS. DOCTOR RETRIEVED THE BITS AND NO OTHER FOREIGN BODY WAS FOUND IN THE SURGICAL AREA. THE PT'S HEALTH WAS NOT COMPROMISED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 348347 | TWIST DRILL | HTW | KARL LEIBINGER MEDIZINTECHNIK GMBH U. CO. KG | 25-469-11-07 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |