FDA Adverse Event
Malfunction
Summary report: N
MICRO SAGGITAL SAW
MDR report key: 2974587
·
Received January 17, 2013
Report
- Report Number
- 1811755-2013-90087
- Event Type
- Malfunction
- Date Received
- January 17, 2013
- Date of Event
- December 19, 2012
- Report Date
- December 19, 2012
- Manufacturer
- STRYKER INSTRUMENTS KALAMAZOO
- Product Code
- ERL
- PMA / PMN Number
- K040300
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
ADD'L INFO WILL BE SUBMITTED ONCE THE QUALITY INVESTIGATION HAS BEEN PERFORMED. THE REASON FOR THE SERIALIZATION STARTING WITH 90XXX IS TO PROVIDE CLARIFICATION FOLLOWING A CHANGE IN STRYKER'S ELECTRONIC COMPLAINT SYSTEMS.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY, THE BLADES USED WITH THIS SAW WERE BREAKING. THERE WAS NO REPORT OF ANY BLADE PIECES ENTERING THE SURGICAL SITE. THE USER FACILITY DISPOSED OF THE BLADES. BACKUP EQUIPMENT WAS USED TO COMPLETE THE PROCEDURE. NO DELAY, NO ADVERSE CONSEQUENCES AND NO MEDICAL INTERVENTION WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 27317 | MICRO SAGGITAL SAW | ERL | STRYKER INSTRUMENTS KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |