FDA Adverse Event
Malfunction
Summary report: N
ORTHOLOC® 3DI PLATING SYSTEM-DEPTH GAUGE
MDR report key: 5082481
·
Received September 16, 2015
Report
- Report Number
- 1043534-2015-00067
- Event Type
- Malfunction
- Date Received
- September 16, 2015
- Date of Event
- July 14, 2015
- Report Date
- September 16, 2015
- Manufacturer
- WRIGHT MEDICAL TECHNOLOGY, INC.
- Product Code
- HTJ
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DIMENSIONAL INSPECTION OF THE DEPTH GAUGE SHOWS THAT THE READING ON THE SCALE SHOWS 70 MM. BASED ON ANALYSIS, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.
Additional Manufacturer Narrative · 1
INVESTIGATION NOT COMPLETE. INFORMATION PERTAINING TO THE DELAY IN SURGERY WAS RECEIVED 08/19/2015. PRODUCT HAS BEEN RETURNED. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
ALLEGEDLY, THE DEPTH GAUGE READINGS RESULTED IN THE USE OF SCREWS THAT WERE LONGER THAN DESIRED. HAD TO SWAP OUT SCREWS WITH SHORTER SCREWS, WHICH DELAYED SURGERY APPROXIMATELY 30 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 614253 | ORTHOLOC® 3DI PLATING SYSTEM-DEPTH GAUGE | SMALL JOINT COMPONENT | HTJ | WRIGHT MEDICAL TECHNOLOGY, INC. | 1294428 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |