FDA Adverse Event
Malfunction
Summary report: N
5.0CM SHORT ATTACHMENT
MDR report key: 3963934
·
Received December 13, 2013
Report
- Report Number
- 1045834-2013-13085
- Event Type
- Malfunction
- Date Received
- December 13, 2013
- Report Date
- January 9, 2012
- Manufacturer
- DEPUY SYNTHES POWER TOOLS
- Product Code
- HBC
- PMA / PMN Number
- K011444
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RECEIVED BY DEPUY SYNTHES POWER TOOLS. THE DEVICE WAS EVALUATED AND THE REPORTED FAILURE OF "DOES NOT FUNCTION" COULD NOT BE CONFIRMED. THE DEVICE PASSED ALL TESTS AND NO FAILURES WERE OBSERVED. IF ADD'L INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SENT. REF: (B)(4).
Description of Event or Problem · 1
REPORT RECEIVED FROM USA STATING DEVICE DID NOT FUNCTION. THE DEVICE WAS NOT USED IN SURGERY. IT IS UNK IF INJURY OR MEDICAL INTERVENTION OCCURRED. THERE WAS NO ADD'L INFO PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 652905 | 5.0CM SHORT ATTACHMENT | HBC | DEPUY SYNTHES POWER TOOLS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |