FDA Adverse Event
Malfunction
Summary report: N
TRANSFX EXTERNAL FIXATION SYSTEM DRILL BIT QUICK-CONNECT
MDR report key: 1220792
·
Received October 31, 2008
Report
- Report Number
- 1822565-2008-00747
- Event Type
- Malfunction
- Date Received
- October 31, 2008
- Date of Event
- September 23, 2008
- Report Date
- September 23, 2008
- Manufacturer
- ZIMMER, INC.
- Product Code
- HTW
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT THE DRILL BITS ARE NOT DRILLING INTO THE BONE VERY EASILY. THE DRILL BITS WILL SPIN ON TOP OF THE BONE FOR AWHILE BEFORE ACTUALLY BREAKING THROUGH CORTICAL BONE. IT IS ALLEGED THAT THIS MAY BE CAUSING NECROSIS IN THOSE AREAS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRANSFX EXTERNAL FIXATION SYSTEM DRILL BIT QUICK-CONNECT | TRAUMA INSTRUMENT | HTW | ZIMMER, INC. | NA | 60644759 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | LOT# 56454692| CONNECT: CATALOG# 00445006300| TRANSFX EXTERNAL FIXATION SYSTEM DRILL BIT QUICK- |