FDA Adverse Event
Malfunction
Summary report: N
NEXGEN HEX DRIVER BIT
MDR report key: 2670485
·
Received July 20, 2012
Report
- Report Number
- 1822565-2012-01547
- Event Type
- Malfunction
- Date Received
- July 20, 2012
- Date of Event
- June 12, 2012
- Report Date
- June 20, 2012
- Manufacturer
- ZIMMER INC
- Product Code
- LXH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVAL SUMMARY: AS RECEIVED, THE INSTRUMENT SHOWED EVIDENCE OF SIGNIFICANT USAGE DURING ITS 7.4 YEAR LIFE IN THE FIELD. EVAL: ITEM EXHIBITS STAINS ON KNURL AND INSIDE BOX DRIVE. THE HARDNESS OF THE RECEIVED INSTRUMENT WAS WITHIN SPECIFICATION. THE HEXAGONAL AREA OF THE DRIVER SHOWED EVIDENCE OF ABNORMAL FORCE BEING APPLIED.
Description of Event or Problem · 1
IT IS REPORTED THAT WHEN THE PHYSICIAN WAS TRYING TO REMOVE THE HINGE POST EXTENSION FROM AN RHK FEMORAL COMPONENT WHEN THE HEX HEAD ATTACHMENT BROKE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEXGEN HEX DRIVER BIT | KNEE INSTRUMENT | LXH | ZIMMER INC | 60261815 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |