FDA Adverse Event
Malfunction
Summary report: N
LINVATEC BEATH PIN PASSER
MDR report key: 35358
·
Received July 1, 1996
Report
- Report Number
- 35358
- Event Type
- Malfunction
- Date Received
- July 1, 1996
- Date of Event
- February 21, 1996
- Report Date
- February 27, 1996
- Manufacturer
- LINVATEC, INC.
- Product Code
- HWQ
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- IL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
MD UNABLE TO TAP IN FEMUR SCREW SO WAS DRILLING SCREW INTO PLACE WHEN TIP BROKE OFF - AT SOLDERED SITE AND LODGED IN BONE. SURGERY (LAPAROSCOPIC) FOR ANTERIOR CRUCIATE LIGAMENT REPAIR (LEFT KNEE).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LINVATEC BEATH PIN PASSER | BEATH PIN PASSER | HWQ | LINVATEC, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 17 YR |