FDA Adverse Event
Malfunction
Summary report: N
2520274-2013-03805
MDR report key: 3223369
·
Received July 12, 2013
Report
- Report Number
- 2520274-2013-03805
- Event Type
- Malfunction
- Date Received
- July 12, 2013
- Date of Event
- June 17, 2013
- Report Date
- June 17, 2013
- Manufacturer
- SYNTHES USA
- Product Code
- HSB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.
Description of Event or Problem · 1
DURING A TFN PROCEDURE ON (B)(6) 2013, WHILE INSERTING THE HELICAL BLADE, IT WAS REPORTED THE HELICAL BLADE WAS NOT ADVANCING THROUGH THE HOLE IN THE NAIL. REPORTEDLY THE SURGEON WAS ABLE TO REACH THE APPROPRIATE DEPTH AND IMPLANTATION WAS COMPLETED. THE SURGEON BELIEVES THE ISSUE WAS WITH A SMALL, THIN PIECE OF METAL ON THE HELICAL BLADE INSERTER. THIS REPORT IF FOR AN UNKNOWN NAIL. THIS IS 2 OF 3 REPORTS FOR THE SAME EVENT, COMPLAINT #(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 322657 | HSB | SYNTHES USA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |