FDA Adverse Event
Injury
Summary report: N
4.3MM CANNULATED DRILL BIT/QC 200MM
MDR report key: 2032580
·
Received March 23, 2011
Report
- Report Number
- 1719045-2011-00130
- Event Type
- Injury
- Date Received
- March 23, 2011
- Date of Event
- February 24, 2011
- Report Date
- February 28, 2011
- Manufacturer
- SYNTHES MONUMENT
- Product Code
- HWE
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFO HAS BEEN REQUESTED. SUBJECT DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED OR EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED. A DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED.
Description of Event or Problem · 1
DURING AN ORIF OF A HIP SURGEON WAS USING THE 4.3 MM CANNULATED DRILL BIT AND THE TIP BROKE OFF INTO THE PT'S BONE. SURGEON COULD NOT RETRIEVE THE DRILL BIT PIECE AND IT REMAINS IN THE BONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 4.3MM CANNULATED DRILL BIT/QC 200MM | CANNULATED DRILL BIT | HWE | SYNTHES MONUMENT | NA | 36485 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Required Intervention |