FDA Adverse Event
Malfunction
Summary report: N
2MM COARSE DIAMOND ALL, EXT
MDR report key: 3984240
·
Received December 18, 2013
Report
- Report Number
- 1045834-2013-14894
- Event Type
- Malfunction
- Date Received
- December 18, 2013
- Date of Event
- April 5, 2011
- Report Date
- April 6, 2011
- Manufacturer
- DEPUY SYNTHES POWER TOOLS
- Product Code
- HBC
- PMA / PMN Number
- K011444
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE REPORTED PROBLEM WAS CONFIRMED. THIS PACKAGING DEFECT, WHICH WAS DUE TO THE WHITE POLYETHYLENE LAYER OR THE POUCH BECOMING BRITTLE BEFORE THE 60 MONTH EXPIRY DATE, HAD BEEN PREVIOUSLY IDENTIFIED AND INVESTIGATED IN (B)(4) 2007. THE INVESTIGATION RESULTED IN FIELD REMOVAL ACTION #05/18/07-005R. IF ADDITIONAL INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
REPORT RECEIVED FROM USA STATING THAT DEVICE POUCH DISINTEGRATED WHEN THE OPERATOR TRIED TO OPEN IT DURING SURGERY. NO INJURIES WERE REPORTED TO HAVE OCCURRED, HOWEVER, IT IS UNK IF MEDICAL INTERVENTION WAS NECESSARY. THERE IS NO ADDITIONAL INFO AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 664040 | 2MM COARSE DIAMOND ALL, EXT | HBC | DEPUY SYNTHES POWER TOOLS | 315942 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NI |