FDA Adverse Event
Malfunction
Summary report: N
10 X 28MM BIOABSORBABLE WEDGE INTERFERENCE SCREW
MDR report key: 2133226
·
Received May 9, 2011
Report
- Report Number
- 2936485-2011-00303
- Event Type
- Malfunction
- Date Received
- May 9, 2011
- Date of Event
- September 27, 2010
- Report Date
- April 14, 2011
- Manufacturer
- STRYKER ENDOSCOPY SAN JOSE
- Product Code
- MAI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO WILL BE PROVIDED ONCE THE INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE PROCEDURE, THE UNIT BROKE WHILE BEING INSERTED INTO THE TIBIA. IT WAS FURTHER REPORTED THAT PART OF THE UNIT REMAINED STUCK TO THE SCREWDRIVER WHILE THE SURGEON TRIED TO REMOVE THE BROKEN PIECES FROM THE TIBIA. THERE WERE NO REPORTS OF ANY ADVERSE CONSEQUENCES TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 10 X 28MM BIOABSORBABLE WEDGE INTERFERENCE SCREW | SCREW | MAI | STRYKER ENDOSCOPY SAN JOSE | 76632 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |