FDA Adverse Event
Malfunction
Summary report: N
JUGGERKNOT MINI, ONE 3-0 MAXBRAID - BLUE / WHIT
MDR report key: 16278953
·
Received January 31, 2023
Report
- Report Number
- MW5114615
- Event Type
- Malfunction
- Date Received
- January 31, 2023
- Date of Event
- October 6, 2022
- Report Date
- January 12, 2023
- Manufacturer
- ZIMMER BIOMET CENTROAMERICA SA
- Product Code
- MBI
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CO, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
ZIMMER BIOMET ONE-TIME USE JUGGERKNOT SOFT ANCHOR 912082 MALFUNCTIONED, TIP OF ANCHOR BROKEN. NEW ANCHOR OPENED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 903150 | JUGGERKNOT MINI, ONE 3-0 MAXBRAID - BLUE / WHIT | FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE | MBI | ZIMMER BIOMET CENTROAMERICA SA | 912082 | 005710 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Male |