FDA Adverse Event
Malfunction
Summary report: N
4 MM FLUTED BALL, MIA 20 CM
MDR report key: 3983773
·
Received December 18, 2013
Report
- Report Number
- 1045834-2013-13354
- Event Type
- Malfunction
- Date Received
- December 18, 2013
- Date of Event
- June 25, 2012
- Report Date
- August 9, 2012
- Manufacturer
- DEPUY SYNTHES POWER TOOLS
- Product Code
- HSZ
- PMA / PMN Number
- K981465
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE DEVICE WAS EVALUATED AND THE REPORTED CONDITION OF "DID NOT MEET DISTRIBUTOR SPECIFICATIONS" COULD NOT BE CONFIRMED. THE DEVICE PASSED ALL TESTS AND NO PROBLEMS WERE OBSERVED. IF ADDITIONAL INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).
Description of Event or Problem · 1
REPORT RECEIVED FROM (B)(6) STATING THAT THE DEVICE CONTAINED FOREIGN "DEBRIS IN THE STERILE POUCH." THE DEVICE WAS NOT USED DURING SURGERY. THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED. THERE IS NO ADDITIONAL INFO PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 664405 | 4 MM FLUTED BALL, MIA 20 CM | HSZ | DEPUY SYNTHES POWER TOOLS | E473056198 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |