FDA Adverse Event
Malfunction
Summary report: N
HIP GENERAL OFFSET-30° BROACH HANDLE - RIGHT
MDR report key: 8319910
·
Received February 8, 2019
Report
- Report Number
- 3005180920-2019-00046
- Event Type
- Malfunction
- Date Received
- February 8, 2019
- Date of Event
- January 11, 2019
- Report Date
- March 6, 2019
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LXH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: THE SPRING BALL PLUNGER IS CAME APART. IT IS POSSIBLE THIS OCCURRENCE WAS INFLUENCED BY VARIATION IN PRODUCTION/ASSEMBLY, HOWEVER THIS CANNOT BE CONFIRMED.
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 08 FEBRUARY 2019. LOT 1851540: (B)(4). NO ANOMALIES FOUND RELATED TO THE ISSUE. TO DATE, NO SIMILAR EVENT ON THE SAME LOT HAS BEEN REGISTERED. OTHER LOT INVOLVED LOT 1210183C: (B)(4). NO ANOMALIES FOUND RELATED TO THE PROBLEM.
Description of Event or Problem · 1
THE BALL SPRING FELL OUT FROM 2 HANDLES. THE SURGERY WAS COMPLETED SUCCESSFULLY, WITH 5 MINUTES OF DELAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 112220 | HIP GENERAL OFFSET-30° BROACH HANDLE - RIGHT | SURGICAL INSTRUMENT FOR HIP | LXH | MEDACTA INTERNATIONAL SA | 1851540 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |