FDA Adverse Event
Injury
Summary report: N
UNKNOWN JUGGERKNOT 1.4
MDR report key: 2983041
·
Received February 28, 2013
Report
- Report Number
- 0001825034-2013-00406
- Event Type
- Injury
- Date Received
- February 28, 2013
- Report Date
- February 5, 2013
- Manufacturer
- BIOMET ORTHOPEDICS
- Product Code
- MBI
- PMA / PMN Number
- PUNKNOWN
- Removal / Correction Number
- N/A
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.
Description of Event or Problem · 1
IT WAS REPORTED PATIENT UNDERWENT AN ANTERIOR TALOFIBULAR LIGAMENT PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE JUGGERKNOT 1.4 SLID OFF INSERTION. AS A RESULT, THE SURGEON DRILLED A NEW HOLE IN A DIFFERENT SPOT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 86510 | UNKNOWN JUGGERKNOT 1.4 | FASTENER, FIXATION | MBI | BIOMET ORTHOPEDICS | N/A | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Hospitalization| R |