FDA Adverse Event
Other
Summary report: N
ARTHREX, INC.
MDR report key: 464680
·
Received June 9, 2003
Report
- Report Number
- 1220246-2002-00003
- Event Type
- Other
- Date Received
- June 9, 2003
- Date of Event
- September 12, 2002
- Report Date
- September 24, 2002
- Manufacturer
- ARTHREX, INC.
- Product Code
- MAI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
A QUANITY OF (6) BIO-SUTURETAKS WERE OPENED B/C IMPLANT WOULD NOT SEAT ON/IN DRIVER. THERE WERE 2 OPPOSING "BUMPS" ON THE SHAFT OF THE IMPLANT THAT PREVENTED THE IMPLANT FROM FULLY SEATING ON THE DRIVER. THE IMPLANT BROKE INTO 2 PIECES WHICH THEN CAUSED THE SHAFT TO SCRAPE ACROSS THE GLENOID, SCRAPING OFF A 4 MM SECTION OF CARTILAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ARTHREX, INC. | BIO-SUTURETAK, 3.00 MM | MAI | ARTHREX, INC. | AR-1934B | 28026 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Other |