FDA Adverse Event
Injury
Summary report: N
BONE MULCH SCREW +5 TIP
MDR report key: 511572
·
Received February 12, 2004
Report
- Report Number
- 2027970-2004-00001
- Event Type
- Injury
- Date Received
- February 12, 2004
- Date of Event
- January 5, 2004
- Report Date
- January 16, 2004
- Manufacturer
- ARTHROTEK, INC.
- Product Code
- HWC
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
DURING ACL RECONSTRUCTION, TIP OF ARTHROTEK BONE MULCH SCREW, 10.5 MM X 20 MM BROKE OFF. THE BULK OF THE SCREW WAS REMOVED AND DISCARDED, ALTHOUGH THE VERY TIP OF THE SCREW WAS UNABLE TO BE REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BONE MULCH SCREW +5 TIP | SCREW, FIXATION, BONE | HWC | ARTHROTEK, INC. | NA | 910860 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Other |