FDA Adverse Event
Injury
Summary report: N
2.5MM DRILL BIT/QC/GOLD/110MM
MDR report key: 2020148
·
Received March 7, 2011
Report
- Report Number
- 1719045-2011-00104
- Event Type
- Injury
- Date Received
- March 7, 2011
- Date of Event
- February 4, 2011
- Report Date
- February 8, 2011
- Manufacturer
- SYNTHES MONUMENT
- Product Code
- HWE
- PMA / PMN Number
- K962913
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS INFO WAS NOT PROVIDED DURING INITIAL REPORT. ADD'L INFO HAS BEEN REQUESTED. SUBJECT DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED. INVESTIGATION IS ON GOING; NO CONCLUSION CAN BE DRAWN AS NO DEVICE WAS RETURNED. REVIEW OF THE MFG RECORDS HAS BEEN REQUESTED.
Description of Event or Problem · 1
DURING AN ORIF OF A DISTAL HUMERUS, THE DRILL BIT BROKE. A PORTION OF THE DRILL BIT WAS LEFT IN THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 2.5MM DRILL BIT/QC/GOLD/110MM | QUICK COUPLING DRILL BITS | HWE | SYNTHES MONUMENT | NA | U128455 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | Required Intervention |