FDA Adverse Event
Malfunction
Summary report: N
2.8MM DRILL BIT/QC/165MM
MDR report key: 2220482
·
Received July 18, 2011
Report
- Report Number
- 8030965-2011-00309
- Event Type
- Malfunction
- Date Received
- July 18, 2011
- Date of Event
- June 25, 2011
- Report Date
- June 27, 2011
- Manufacturer
- SYNTHES GMBH
- Product Code
- HTW
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SUBJECT DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED. SUBJECT DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION.
Description of Event or Problem · 1
DEVICE REPORT RECEIVED FROM (B)(4) HOSPITAL IN (B)(4) INDICATES DURING DRILLING THE DRILL BIT BENT AND APPROXIMATELY 2MM OF THE TIP BROKE AND WAS RETAINED WITHIN THE BONE AND ENCLOSED BY THE PLATE. AT THIS TIME, THE SURGEON PLANS TO REMOVE THE DRILL BIT WHEN HE REMOVED THE PLATE AFTER FRACTURE IS HEALED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 2.8MM DRILL BIT/QC/165MM | 2.8MM DRILL BIT/QC/165MM | HTW | SYNTHES GMBH | NA | 2211682 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |