FDA Adverse Event
Other
Summary report: N
BILOK DRIVER 25MM
MDR report key: 1943569
·
Received December 3, 2010
Report
- Report Number
- 2951580-2010-00101
- Event Type
- Other
- Date Received
- December 3, 2010
- Date of Event
- May 1, 2010
- Report Date
- December 3, 2010
- Manufacturer
- ARTHROCARE CORP.
- Product Code
- LXH
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE PATIENT INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE. A VISUAL INSPECTION OF THE DEVICE WAS PERFORMED: THE DISTAL END BROKE OFF THE DRIVER. A LOT HISTORY REVIEW WAS PERFORMED. NO ABNORMALITIES WERE FOUND DURING THE LOT REVIEW. THE ROOT CAUSE OF THE FAILURE WAS FOUND TO BE FROM THE DEVICE BEING MISUSED WITH EXCESSIVE FORCE.
Description of Event or Problem · 1
DURING AN ACL RECONSTRUCTION PROCEDURE USING A BILOK DRIVER 25MM, TIP REPORTEDLY BROKE OFF IN SCREW AND WAS LEFT IN PATIENT. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BILOK DRIVER 25MM | ORTHOPEDIC MANUAL SURGICAL INSTRUMENT | LXH | ARTHROCARE CORP. | 25516 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |