FDA Adverse Event
Malfunction
Summary report: N
HIP GENERAL OFFSET-30° BROACH HANDLE - RIGHT
MDR report key: 8436667
·
Received March 20, 2019
Report
- Report Number
- 3005180920-2019-00167
- Event Type
- Malfunction
- Date Received
- March 20, 2019
- Date of Event
- February 18, 2019
- Report Date
- March 20, 2019
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LXH
- UDI-DI
- 07630040742115
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
VISUAL INSPECTION PERFORMED BY R&D PROJECT MANAGER: THE SPRING PLUNGER IS BROKEN. IT IS POSSIBLE THAT THIS EVENT COULD HAVE BEEN INFLUENCED BY INSTRUMENT WEAR , HOWEVER THIS CANNOT BE CONFIRMED. BATCH REVIEW PERFORMED ON 18 MARCH 2019: LOT 1414926: 25 ITEMS MANUFACTURED AND RELEASED ON 25-NOV-2015; 9 ITEMS MANUFACTURED AND RELEASED ON 25-APR-2016; 16 ITEMS MANUFACTURED AND RELEASED ON 02-MAY-2016. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ANOTHER SIMILAR EVENT HAS BEEN REPORTED (MDR 2018-01036).
Description of Event or Problem · 1
DURING SURGERY THE LOCKING BALL FELL OUT OF THE HANDLE WHILE A NURSE WANTED TO REMOVE THE BROACH FROM THE HANDLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 228436 | HIP GENERAL OFFSET-30° BROACH HANDLE - RIGHT | SURGICAL INSTRUMENT FOR HIP | LXH | MEDACTA INTERNATIONAL SA | 1414926 | 07630040742115 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |