FDA Adverse Event
Malfunction
Summary report: N
LOCKING SCREW, FULLY THREADED 5X50MM
MDR report key: 1816880
·
Received August 24, 2010
Report
- Report Number
- 9610622-2010-00344
- Event Type
- Malfunction
- Date Received
- August 24, 2010
- Date of Event
- August 2, 2010
- Report Date
- August 4, 2010
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HSB
- PMA / PMN Number
- K003018
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
DEVICE REMAINS IMPLANTED. NO EVALUATION WILL BE PERFORMED. IF THE DEVICE OR ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
IT WAS REPORTED BY THE NURSE THAT, MONDAY EVENING A PATIENT WITH A FRACTURED FEMUR HAD A GAMMA3 LONG NAIL IMPLANTED. THE TWO DISTAL SCREWS USED WERE BOTH LABELED AS 50 MM ((B)(4) LOTS K295621 AND K189255). FROM THE XRAY, IT IS EVIDENT THAT TWO SCREWS ARE NOT OF THE SAME LENGTH. THE SURGEON DID NOT WANT TO CHANGE THE SCREWS, BECAUSE IT WOULD NOT CREATE A PROBLEM FOR THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LOCKING SCREW, FULLY THREADED 5X50MM | IMPLANT | HSB | STRYKER OSTEOSYNTHESIS KIEL | NA | K295621/K189255 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |