FDA Adverse Event
Malfunction
Summary report: N
TITLE II LOCKING SCREW DRIVER
MDR report key: 1515231
·
Received October 22, 2009
Report
- Report Number
- 2184052-2009-00076
- Event Type
- Malfunction
- Date Received
- October 22, 2009
- Date of Event
- September 22, 2009
- Report Date
- September 23, 2009
- Manufacturer
- ZIMMER SPINE, INC.
- Product Code
- HXX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE HISTORY RECORD REVIEWED. REVIEW OF THE DEVICE HISTORY RECORDS INDICATE THE DEVICE WAS MFG TO SPECIFICATION. THE BROKEN END (DISTAL TIP) OF THE DEVICE WAS NOT RETURNED FOR EVAL.
Description of Event or Problem · 1
DURING SURGERY, THE TIP OF THE DRIVER BROKE OFF IN THE SCREW WHILE TRYING TO REMOVE THE DRIVER FROM THE SCREW. THE TIP OF THE DRIVER WAS JAMMED IN THE SCREW AND LEFT IN THE SCREW. ANOTHER LOCKING SCREW DRIVER WAS USED TO COMPLETE THE SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TITLE II LOCKING SCREW DRIVER | LOCKING SCREW DRIVER | HXX | ZIMMER SPINE, INC. | ET1091-01 | LW13809/1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR |