FDA Adverse Event
Malfunction
Summary report: N
SD/PD LONG STRAIGHT
MDR report key: 3092177
·
Received May 3, 2013
Report
- Report Number
- 0001811755-2013-01020
- Event Type
- Malfunction
- Date Received
- May 3, 2013
- Date of Event
- April 22, 2013
- Report Date
- April 22, 2013
- Manufacturer
- STRYKER INSTRUMENTS-KALAMAZOO
- Product Code
- ERL
- PMA / PMN Number
- K040300
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS IS A DUPLICATE REPORTING OF THE EVENT ON (B)(4).
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION HAS BEEN PERFORMED.
Description of Event or Problem · 1
IT WAS REPORTED THAT UPON THE RETURN OF A MARKETING SAMPLE, A BROKEN BUR WAS FOUND IN THE ATTACHMENT. IT IS REPORTED THAT NO PATIENT WAS AFFECTED, THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT OR THE USER, NO MEDICAL INTERVENTION, AND NO DELAY TO A PROCEDURE.
Description of Event or Problem · 1
IT WAS REPORTED THAT UPON THE RETURN OF A MARKETING SAMPLE, A BROKEN BUR WAS FOUND IN THE ATTACHMENT. IT IS REPORTED THAT NO PATIENT WAS AFFECTED, THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT OR THE USER, NO MEDICAL INTERVENTION, AND NO DELAY TO A PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 193742 | SD/PD LONG STRAIGHT | DRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE | ERL | STRYKER INSTRUMENTS-KALAMAZOO | 10123 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN BUR |