FDA Adverse Event
Malfunction
Summary report: N
ANTERIOR CRUCIATE LIGAMENT PASSING PIN
MDR report key: 28152
·
Received November 17, 1995
Report
- Report Number
- MW1007705
- Event Type
- Malfunction
- Date Received
- November 17, 1995
- Date of Event
- October 31, 1995
- Report Date
- November 10, 1995
- Manufacturer
- ACUFEX MICROSURGICAL, INC.
- Product Code
- HXI
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- CO, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
AFTER DRILLING, THE DR NOTED THAT THE ANTERIOR CRUCIATE LIGAMENT PASSING PIN WAS SHORTER AND THE TIP WAS MISSING; PIN TIP RETRIEVED FROM PT'S KNEE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANTERIOR CRUCIATE LIGAMENT PASSING PIN | PASSING PIN | HXI | ACUFEX MICROSURGICAL, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 23 YR | Other |