FDA Adverse Event
Malfunction
Summary report: N
TARGET DEVICE GAMMA3 300X160MM
MDR report key: 2934105
·
Received December 19, 2012
Report
- Report Number
- 9610622-2012-00603
- Event Type
- Malfunction
- Date Received
- December 19, 2012
- Date of Event
- December 11, 2012
- Report Date
- December 12, 2012
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- LXH
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADD'L INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ADD'L DEVICE: 1320-0150 GUIDE WIRE SLEEVE GAMMA3 10.5X268MM UNK.
Description of Event or Problem · 1
DURING G3 SURGERY, THE SURGEON INSERTED GUIDE WIRE FOR LAG SCREW, AFTER INSERTING THE NAIL. HOWEVER, THE GUIDE WIRE WAS INSERTED IN THE UPPER PART OF THE NAIL. THE SURGEON REMOVED THE NAIL AND CHECKED, THE LAG SCREW ANGLE OF THE NAIL AND THE TARGET ARM WAS NOT IN CONFORMANCE. THE OPERATION CONTINUED. AFTERWARDS, WHEN THE STEP DRILL WAS USED, THE DRILL WAS STUCK IN THE LAG SCREW HOLE OF NAIL. THE SURGEON LOOSENED THE NAIL HOLDING SCREW AND REMOVED THE STEP DRILL. THE SURGERY WAS COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TARGET DEVICE GAMMA3 300X160MM | INSTRUMENT | LXH | STRYKER OSTEOSYNTHESIS KIEL | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |