FDA Adverse Event
Injury
Summary report: N
ZIMMER DERMATOME SCREWDRIVER
MDR report key: 1132127
·
Received August 21, 2008
Report
- Report Number
- 1526350-2008-00033
- Event Type
- Injury
- Date Received
- August 21, 2008
- Date of Event
- March 14, 2008
- Report Date
- July 22, 2008
- Manufacturer
- ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS
- Product Code
- HXX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A CLINICAL INCIDENT OCCURRED IN 2008, WHERE THE PLATE SCREWS BECAME LOOSE AND CAUSED THE DERMATOME TO TAKE A DEEPER GRAFT THAN ANTICIPATED. THE SCREWS WERE RE-TIGHTENED, HOWEVER, THE PROBLEM OCCURRED AGAIN WITH SCREWS LOOSENING CAUSING DEEPER GRAFTING. DURING THE INCIDENT INVESTIGATION IT WAS FOUND THAT THE SCREWS AND SCREWDRIVER OF THE DERMATOME SET WERE HEAVILY WORN. SUBSEQUENTLY, THE NEW SCREWDRIVER AND SCREW HAD BEEN ORDERED AND RECEIVED, HOWEVER, THE NEW SCREWDRIVER STILL "SLIPS" BEFORE THE SCREWS ARE PROPERLY TIGHTENED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZIMMER DERMATOME SCREWDRIVER | DERMATOME SCREWDRIVER | HXX | ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |