FDA Adverse Event
Malfunction
Summary report: N
EAGLE PLUS SCREW REMOVAL TOOL INNER SHAFT
MDR report key: 1230989
·
Received October 28, 2008
Report
- Report Number
- 1526439-2008-00182
- Event Type
- Malfunction
- Date Received
- October 28, 2008
- Date of Event
- September 30, 2008
- Report Date
- September 30, 2008
- Manufacturer
- DEPUY SPINE, INC.
- Product Code
- LXH
- PMA / PMN Number
- EXEMPT
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NO DEFINITIVE CONCLUSIONS CAN BE MADE AT THIS TIME. HOWEVER, IT IS LIKELY THAT THE APPLICATION OF EXCESSIVE FORCE DURING SCREW TIGHTENING RESULTED IN THE INNER SHAFT TIP BREAKAGE. A FOLLOW UP MEDWATCH REPORT WILL BE FILED OF THE EVALUATION IF THE RETURNED INSTRUMENT REVEALS SOMETHING OTHER THAN THAT WHICH IS STATED ABOVE.
Description of Event or Problem · 1
INTERNATIONAL AFFILIATE REPORTS THE HEXAGONAL TIP OF THE INSTRUMENT BROKE OFF IN THE HEAD OF THE SCREW DURING SPINAL SURGERY. THE BROKEN TIP REMAINS LODGED IN THE HEAD OF THE IMPLANTED SCREW. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EAGLE PLUS SCREW REMOVAL TOOL INNER SHAFT | ORTHOPAEDIC MANUAL SURGICAL INSTRUMENT | LXH | DEPUY SPINE, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | EAGLE PLUS THREADED DRIVER |