FDA Adverse Event
Injury
Summary report: N
1.1MM DRILL BIT
MDR report key: 2032600
·
Received March 23, 2011
Report
- Report Number
- 8030965-2011-00094
- Event Type
- Injury
- Date Received
- March 23, 2011
- Date of Event
- March 7, 2011
- Report Date
- March 9, 2011
- Manufacturer
- SYNTHES (USA)
- Product Code
- HTW
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SUBJECT DEVICE IS AN INSTRUMENT. MANUFACTURE SITE AND MANUFACTURE DATE COULD NOT BE DETERMINED WITHOUT A LOT NUMBER. INVESTIGATION COULD NOT BE CONCLUDED, NO CONCLUSION COULD BE DRAWN.
Description of Event or Problem · 1
DEVICE REPORT RECEIVED FROM PRINCESS (B)(6) HOSPITAL, (B)(6), INDICATES THE TIP OF A DRILL BIT BROKE OFF IN THE PT'S INFERIOR ORBITAL RIM AND THE SURGEON DECIDED TO LEAVE IT IN THE PT. THE SURGEON INDICATED ABOUT 2MM WAS LEFT IN THE PT WHICH HE FELT WAS THE BEST OPTION FOR THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 1.1MM DRILL BIT | 1.1MM DRILL BIT | HTW | SYNTHES (USA) | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention |