FDA Adverse Event
Injury
Summary report: N
1.8MM DRILL BIT WITH DEPTH
MDR report key: 2032610
·
Received March 23, 2011
Report
- Report Number
- 1719045-2011-00127
- Event Type
- Injury
- Date Received
- March 23, 2011
- Date of Event
- January 31, 2011
- Report Date
- March 4, 2011
- Manufacturer
- SYNTHES MONUMENT
- Product Code
- HWE
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED. SUBJECT DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED. INVESTIGATION COULD NOT BE CONCLUDED, NO CONCLUSION COULD BE DRAWN. NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER.
Description of Event or Problem · 1
DURING A PROCEDURE, THE TIP OF THE 1.8MM DRILL BIT BROKE OFF. THE DRILL BIT WAS DISCARDED AFTER PROCEDURE. THE TIP REMAINS IN THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 1.8MM DRILL BIT WITH DEPTH | 1.8MM DRILL BIT WITH DEPTH | HWE | SYNTHES MONUMENT | NA | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI | Required Intervention |