FDA Adverse Event
Injury
Summary report: N
TBD
MDR report key: 2191735
·
Received August 4, 2011
Report
- Report Number
- 1625507-2011-00101
- Event Type
- Injury
- Date Received
- August 4, 2011
- Date of Event
- July 4, 2011
- Report Date
- July 5, 2011
- Manufacturer
- MDT POWERED SURGICAL SOLUTIONS
- Product Code
- HBB
- PMA / PMN Number
- K020069
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
REPORT NOT CONFIRMED. EVALUATION COULD NOT IDENTIFY ANY ABNORMALITIES WITH THE DEVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT "HAND PIECE "EXPLODED" DURING SURGERY, DARK LIQUID AND MOST PROBABLY METAL DEBRIS LEAKED INTO OPERATION FIELD, BALL BEARINGS ARE MOST PROBABLY DAMAGED. OPERATION FIELD WAS RINSED AND SOME CONTAMINATED SOFT TISSUE REMOVED." ON FOLLOW-UP IT WAS NOTED THAT A STRANGE NOISE WAS HEARD WHILE USING THE DEVICE, THE SURGEON STOPPED DRILLING AND LIQUID STARTED COMING OUT OF THE ATTACHMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TBD | MOTOR, DRILL, PNEUMATIC | HBB | MDT POWERED SURGICAL SOLUTIONS | N/A | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00071 YR | Required Intervention | EM100-A SERIAL # UNK (B)(4) LOT # UNK |