FDA Adverse Event
Other
Summary report: N
BIO-TENODESIS SCREW WITH HANDLED INSERTER, 3MM X 8MM
MDR report key: 909832
·
Received September 7, 2007
Report
- Report Number
- 1220246-2007-00181
- Event Type
- Other
- Date Received
- September 7, 2007
- Date of Event
- August 8, 2007
- Report Date
- August 10, 2007
- Manufacturer
- ARTHREX, INC.
- Product Code
- MBI
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE HAS BEEN RECEIVED AND EVALUATION IS IN PROGRESS. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE IMPLANT SPLIT ALONG THE DRIVER UPON INSERTION. THE SURGEON COMPLETED THE TENDON TRANSFER PROCEDURE USING A DIFFERENT IMPLANT. THE SURGERY WAS DELAYED OVER 30 MINUTES, BUT NO ADVERSE CONSEQUENCES WERE REPORTED FROM THIS EVENT. THIS IS THE FIRST OF TWO REPORTS SUBMITTED FOR THIS EVENT. THIS DEVICE IS USED FOR TREATMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIO-TENODESIS SCREW WITH HANDLED INSERTER, 3MM X 8MM | DRIVER FOR BIO-TENODESIS SCREW | MBI | ARTHREX, INC. | NA | 92608 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Other |