FDA Adverse Event
Malfunction
Summary report: N
LOCKING SCREW, FULLY THREADED 5X35 MM
MDR report key: 1944731
·
Received December 9, 2010
Report
- Report Number
- 9610622-2010-00527
- Event Type
- Malfunction
- Date Received
- December 9, 2010
- Date of Event
- November 26, 2010
- Report Date
- November 26, 2010
- Manufacturer
- STRYKER OSTEOSYNTHESIS KIEL
- Product Code
- HSB
- PMA / PMN Number
- K010801
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
NA
Description of Event or Problem · 1
DURING G3 SURGERY, THE DISTAL LOCKING SCREW WAS STUCK WHEN IT REACHED THE CORTICAL BONE. THE SCREW WAS NOT ABLE TO BE INSERTED. THE SURGEON TRIED INSERTING SEVERAL TIMES. THEREFORE, THE SURGEON CHANGED THE SCREW FROM A 35MM LENGTH TO THE A 40MM LENGTH. THE 40MM LENGTH SCREW WAS TOO LONG. THE SURGEON CHANGED THE SCREW TO A 30MM, AND THE SURGERY WAS COMPLETED. THE SURGEON REQUESTED THE INVESTIGATION OF THE SCREW OF 35MM LENGTH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LOCKING SCREW, FULLY THREADED 5X35 MM | IMPLANT | HSB | STRYKER OSTEOSYNTHESIS KIEL | NA | K173529 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |