FDA Adverse Event
Malfunction
Summary report: N
11.0MM TI HELICAL BLADE 90MM
MDR report key: 3250381
·
Received July 26, 2013
Report
- Report Number
- 2520274-2013-04607
- Event Type
- Malfunction
- Date Received
- July 26, 2013
- Date of Event
- June 28, 2013
- Report Date
- June 28, 2013
- Manufacturer
- SYNTHES USA
- Product Code
- HSB
- PMA / PMN Number
- K011857
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PLACEHOLDER.
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODE FOR THIS REPORT INCLUDES HWB. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. PLACEHOLDER.
Description of Event or Problem · 1
THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED DURING THE PLACEMENT OF A TROCHANTERIC FIXATION NAIL, WHEN INSERTING THE 11 MM TITANIUM HELICAL BLADE IT WOULD NOT GO THROUGH THE TROCHANTERIC FIXATION NAIL. AFTER SOME ADJUSTMENTS, THE SURGEON WAS ABLE TO MAKE IT WORK. THE KNOB OF THE 130 DEGREE GUIDE CAME OFF AND THE SURGEON WAS HOLDING IT BY HAND. THERE WAS ALSO A TEN MINUTE DELAY. THIS REPORT IS FOR AN UNKNOWN HELICAL BLADE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 349577 | 11.0MM TI HELICAL BLADE 90MM | HSB | SYNTHES USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR |