FDA Adverse Event
Malfunction
Summary report: N
CHARLOTTE(R) JONES SCREW
MDR report key: 4943127
·
Received July 27, 2015
Report
- Report Number
- 1043534-2015-00048
- Event Type
- Malfunction
- Date Received
- July 27, 2015
- Date of Event
- June 17, 2015
- Report Date
- July 27, 2015
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- HWC
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION NOT COMPLETE. PRODUCT HAS NOT BEEN RETURNED. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
ALLEGEDLY, HEAD OF SCREW BROKE OFF WHILE FINAL TURNS WERE BEING MADE. INFORMATION WAS RECEIVED ON (B)(4) 2015 THAT THE BROKEN SCREW COULD NOT BE REMOVED AND WAS LEFT IN THE PATIENT. IMPLANTATION SITE: 5TH MET. ISSUE RESOLVED: DOC HASN'T HEARD ANY FEEDBACK, PER (B)(6) EMAIL ON (B)(6) 2015. SALES REP. WAS PRESENT. SURGERY TIME EXTENDED >30 MINUTES: NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 486649 | CHARLOTTE(R) JONES SCREW | SMALL JOINT COMPONENT | HWC | WRIGHT MEDICAL TECHNOLOGY, INC. | 5601-4540 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 49 YR | Other |