FDA Adverse Event
Injury
Summary report: N
JARIT BONE HOOK 3/4"(19MM)
MDR report key: 781114
·
Received November 8, 2006
Report
- Report Number
- 2430952-2006-00046
- Event Type
- Injury
- Date Received
- November 8, 2006
- Report Date
- November 6, 2006
- Manufacturer
- OERTEL MEDIZINTECHNIK
- Product Code
- LXH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE DISTRIBUTOR REPORTED THE FOLLOWING EVENT ON BEHALF OF THE USER FACILITY: A BONE HOOK WAS BEING USED IN A KNEE REPLACEMENT. TIP OF THE BONE HOOK SNAPPED OFF WHEN LIFTING THE FEMUR TO THE BACK OF THE TIBIA. THE PIECE WAS RETRIEVED FROM THE KNEE AND DISPOSED OF AFTER SURGERY. ADDITIONAL INFORMATION CONCERNING PATIENT STATUS AND THE CIRCUMSTANCES OF THE EVENT WAS REQUESTED FROM THE DISTRIBUTOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | JARIT BONE HOOK 3/4"(19MM) | JARIT ORTHOPEDIC SURGERY | LXH | OERTEL MEDIZINTECHNIK | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * | Required Intervention |