FDA Adverse Event
Malfunction
Summary report: N
ANGLED MEDIUM ELITE ATTACHMENT
MDR report key: 2082540
·
Received April 28, 2011
Report
- Report Number
- 1811755-2011-01478
- Event Type
- Malfunction
- Date Received
- April 28, 2011
- Date of Event
- March 30, 2011
- Report Date
- March 31, 2011
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- ERL
- PMA / PMN Number
- K040300
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE ATTACHMENT HAS YET TO BE RECEIVED BY THE MANUFACTURER. A FOLLOW UP REPORT WILL BE FILED ONCE THE PRODUCT EVAL HAS BEEN COMPLETED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A ROUTINE EQUIPMENT EVAL CONDUCTED BY THE MANUFACTURER'S SERVICE REP, A DRILL ATTACHMENT HEATED UP. THIS EVENT DID NOT OCCUR DURING A SURGICAL PROCEDURE, THERE WAS NO PT INVOLVEMENT, NO USER INJURY REPORTED, AND NO ADVERSE CONSEQUENCES ALLEGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANGLED MEDIUM ELITE ATTACHMENT | ERL | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |