FDA Adverse Event
Injury
Summary report: N
SYNTHES ORTHOPEDICS
MDR report key: 988508
·
Received January 22, 2008
Report
- Report Number
- MW5005129
- Event Type
- Injury
- Date Received
- January 22, 2008
- Date of Event
- October 4, 2007
- Report Date
- January 8, 2008
- Manufacturer
- SYNTHES (USA)
- Product Code
- JDS
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
FAILED FEMORAL NAIL SYNTHES. END CAP CAME LOOSE, SPIRAL BLADE BACKED OUT. FOUR PIECE'S TO NAIL. SYNTHES 12MM CANNULATED FEMORAL NAIL, CAT # 474.2365 MCN #4334916, EXP. 12/2010. SYNTHES SPIRAL BLADE 80MM CAT #456.80, LOT # 5180079. 5.0MM SYNTHES LOCKING SCREW CAT # 459.940, LOT # 4578940. END CAP SYNTHES CAT # 457.010, LOT # 4054901.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNTHES ORTHOPEDICS | SYNTHES 12MM CANNULATED FEMORAL NAIL | JDS | SYNTHES (USA) | 4334916 | ||
| 2 | SYNTHES ORTHOPEDICS | SYNTHES SPIRAL BLADE 80MM | KTW | SYNTHES (USA) | 5180079 | ||
| 3 | SYNTHES ORTHOPEDICS | 5.0MM SYNTHES LOCKING SCREW | HWC | SYNTHES (USA) | 4578940 | ||
| 4 | SYNTHES ORTHOPEDIC'S | END CAP SYNTHES | MQP | SYNTHES (USA) | 4054901 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 YR | Required Intervention |