FDA Adverse Event
Malfunction
Summary report: N
QWIX / MESUREUR
MDR report key: 4102329
·
Received August 27, 2014
Report
- Report Number
- 9615741-2014-00040
- Event Type
- Malfunction
- Date Received
- August 27, 2014
- Date of Event
- August 4, 2014
- Report Date
- August 4, 2014
- Manufacturer
- NEWDEAL SAS
- Product Code
- HWC
- PMA / PMN Number
- K071639
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A CALCANEAL FRACTURE SURGERY, THE SURGEON USED THE 5.5 QWIX SCREWS AND A CALCANEAL PLATE. THE SURGEON COULD NOT READ THE DEPTH GAUGE FOR THE QWIX SCREWS, IT WAS TOO FADED OUT. SURGERY WAS COMPLETED WITH NO REPORTED INJURY OR ADVERSE CONSEQUENCES TO THE PATIENT. SURGERY WAS DELAYED BY 5 MINUTES. A SPARE DEVICE WAS NOT AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 522632 | QWIX / MESUREUR | NA | HWC | NEWDEAL SAS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 5.5 QWIX SCREWS| CALCANEAL PLATE |