CORIN OPTIMIZED POSITIONING SYSTEM
Report
- Report Number
- 3012916784-2020-00040
- Event Type
- Malfunction
- Date Received
- January 6, 2020
- Date of Event
- December 19, 2019
- Report Date
- February 12, 2020
- Manufacturer
- OPTIMIZED ORTHO PTY LTD
- Product Code
- LZO
- PMA / PMN Number
- K152893
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- 003
Narratives
NO LASERS AND BATTERIES (K152893) SENT TO THE SURGERY FOR PEN_TY_20198 BY THE EXTERNAL SUPPLIER, RESULTING IN A DELAY OF LESS THAN 20 MINS. IN THIS CASE, THE SURGEON REPRESENTATIVE PROVIDED A LASER FROM THEIR OWN SUPPLY BUT UNFORTUNATELY THEY ONLY HAD ONE LASER, OPPOSED TO THE TWO LASERS REQUIRED FOR INTENDED USE OF THE CORIN OPTIMIZED POSITIONING SYSTEM. THE CORIN OPTIMIZED POSITIONING SYSTEM IS INTENDED TO BE USED WITH TWO LASERS, ONE DIRECTED FROM THE PATIENT'S ACETABULUM AND ONE FROM ANOTHER POINT IN THE ROOM, THE CONVERGENCE OF WHICH ON THE ROOF OF THE OPERATING THEATRE IS USED TO TRACK THE POSITIONING OF THE ACETABULAR COMPONENT OF A TOTAL HIP ARTHROPLASTY PROCEDURE. IN THIS EVENT, THE SURGERY WAS COMPLETED BY MARKETING THE LASER POSITION ON THE ROOF OF THE OPERATING THEATRE, THEREBY USING THE ACETABULAR DELIVERY SYSTEM IN AN OFF-LABEL MANNER. LASER FAILURE OR OFF-LABEL USE MAY LEAD TO TARGET ORIENTATION BEING COMPROMISED, AND POTENTIAL FOR SUB-OPTIMAL ALIGNMENT OF THE ACETABULAR GUIDE LEADING TO SERIOUS INJURY, SIGNIFICANT PAIN OR REQUIREMENT FOR REVISION SURGERY. IN THIS CASE, POST-OPERATIVE IMAGING WAS REQUESTED BUT NOT PROVIDED BY THE SURGEON REPRESENTATIVE. THE SURGEON REPRESENTATIVE CONFIRMED THAT THE SURGEON WAS CONTENT WITH THE ACHIEVED POSITIONING. A ROOT CAUSE INVESTIGATION HAS NOW BEEN CONDUCTED INTO THIS ISSUE. THE INVESTIGATION WAS CONDUCTED WITH THE EXTERNAL SUPPLIER RESPONSIBLE FOR DELIVERING THE LASERS AND BATTERIES TO THIS SURGERY. IT WAS CONFIRMED THAT A SET OF LASERS AND BATTERIES WERE SENT TO THIS CASE, AND EVIDENCE OF THIS WAS SIGHTED IN THE FORM OF THE CHECKLIST FILLED WITH INSTRUMENTS SENT TO EACH CASE. AS A RESULT OF THIS ISSUE, THE ROOT CAUSE OF WHY THE LASERS PROVIDED TO THE HOSPITAL DID NOT MAKE IT TO, OR WERE USED IN, SURGERY COULD NOT BE DETERMINED. IT WAS REITERATED TO THE REPORTER OF THIS ISSUE THAT THIS WAS OFF-LABEL USE OF OPS TECHNOLOGY AND THEREFORE SHOULD NOT BE DONE. THIS REPORT IS FILED WITH THE FDA DUE TO AN EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA, HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA. PLEASE NOTE: THE SUBMISSION OF THIS REPORT DOES NOT CONSTITUTE AND ADMISSION THAT THE DEVICE, REPORTING ENTITY, ENTITY'S REPRESENTATIVE OR DISTRIBUTOR CAUSED OR CONTRIBUTED TO THIS EVENT.
NO LASERS AND BATTERIES (K152893) SENT TO THE SURGERY FOR PEN_TY_20198 BY THE EXTERNAL SUPPLIER, RESULTING IN A DELAY OF LESS THAN 20 MINS. IN THIS CASE, THE SURGEON REPRESENTATIVE PROVIDED A LASER FROM THEIR OWN SUPPLY BUT UNFORTUNATELY THEY ONLY HAD ONE LASER, OPPOSED TO THE TWO LASERS REQUIRED FOR INTENDED USE OF THE CORIN OPTIMIZED POSITIONING SYSTEM. THE CORIN OPTIMIZED POSITIONING SYSTEM IS INTENDED TO BE USED WITH TWO LASERS, ONE DIRECTED FROM THE PATIENT'S ACETABULUM AND ONE FROM ANOTHER POINT IN THE ROOM, THE CONVERGENCE OF WHICH ON THE ROOF OF THE OPERATING THEATRE IS USED TO TRACK THE POSITIONING OF THE ACETABULAR COMPONENT OF A TOTAL HIP ARTHROPLASTY PROCEDURE. IN THIS EVENT, THE SURGERY WAS COMPLETED BY MARKETING THE LASER POSITION ON THE ROOF OF THE OPERATING THEATRE, THEREBY USING THE ACETABULAR DELIVERY SYSTEM IN AN OFF-LABEL MANNER. LASER FAILURE OR OFF-LABEL USE MAY LEAD TO TARGET ORIENTATION BEING COMPROMISED, AND POTENTIAL FOR SUB-OPTIMAL ALIGNMENT OF THE ACETABULAR GUIDE LEADING TO SERIOUS INJURY, SIGNIFICANT PAIN OR REQUIREMENT FOR REVISION SURGERY. IN THIS CASE, POST-OPERATIVE IMAGING WAS REQUESTED BUT NOT PROVIDED BY THE SURGEON REPRESENTATIVE. THE SURGEON REPRESENTATIVE CONFIRMED THAT THE SURGEON WAS CONTENT WITH THE ACHIEVED POSITIONING. A ROOT CAUSE INVESTIGATION HAS NOW BEEN CONDUCTED INTO THIS ISSUE. THE INVESTIGATION WAS CONDUCTED WITH THE EXTERNAL SUPPLIER RESPONSIBLE FOR DELIVERING THE LASERS AND BATTERIES TO THIS SURGERY. IT WAS CONFIRMED THAT A SET OF LASERS AND BATTERIES WERE SENT TO THIS CASE, AND EVIDENCE OF THIS WAS SIGHTED IN THE FORM OF THE CHECKLIST FILLED WITH INSTRUMENTS SENT TO EACH CASE. AS A RESULT OF THIS ISSUE, THE ROOT CAUSE OF WHY THE LASERS PROVIDED TO THE HOSPITAL DID NOT MAKE IT TO, OR WERE USED IN, SURGERY COULD NOT BE DETERMINED. IT WAS REITERATED TO THE REPORTER OF THIS ISSUE THAT THIS WAS OFF-LABEL USE OF OPS TECHNOLOGY AND THEREFORE SHOULD NOT BE DONE. THIS REPORT IS FILED WITH THE FDA DUE TO AN EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA, HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA.
NO LASERS AND BATTERIES (K152893) SENT TO THE SURGERY FOR PEN_TY_20198 BY THE EXTERNAL SUPPLIER, RESULTING IN A DELAY OF LESS THAN 20 MINS. IN THIS CASE, THE SURGEON REPRESENTATIVE PROVIDED A LASER FROM THEIR OWN SUPPLY BUT UNFORTUNATELY THEY ONLY HAD ONE LASER, OPPOSED TO THE TWO LASERS REQUIRED FOR INTENDED USE OF THE CORIN OPTIMIZED POSITIONING SYSTEM. THE CORIN OPTIMIZED POSITIONING SYSTEM IS INTENDED TO BE USED WITH TWO LASERS, ONE DIRECTED FROM THE PATIENT'S ACETABULUM AND ONE FROM ANOTHER POINT IN THE ROOM, THE CONVERGENCE OF WHICH ON THE ROOF OF THE OPERATING THEATRE IS USED TO TRACK THE POSITIONING OF THE ACETABULAR COMPONENT OF A TOTAL HIP ARTHROPLASTY PROCEDURE. IN THIS EVENT, THE SURGERY WAS COMPLETED BY MARKETING THE LASER POSITION ON THE ROOF OF THE OPERATING THEATRE, THEREBY USING THE ACETABULAR DELIVERY SYSTEM IN AN OFF-LABEL MANNER. LASER FAILURE OR OFF-LABEL USE MAY LEAD TO TARGET ORIENTATION BEING COMPROMISED, AND POTENTIAL FOR SUB-OPTIMAL ALIGNMENT OF THE ACETABULAR GUIDE LEADING TO SERIOUS INJURY, SIGNIFICANT PAIN OR REQUIREMENT FOR REVISION SURGERY. IN THIS CASE, POST-OPERATIVE IMAGING WAS REQUESTED BUT NOT PROVIDED BY THE SURGEON REPRESENTATIVE. THE SURGEON REPRESENTATIVE CONFIRMED THAT THE SURGEON WAS CONTENT WITH THE ACHIEVED POSITIONING. THIS REPORT IS FILED WITH THE FDA DUE TO AN EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA, HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA.
NO LASERS AND BATTERIES (K152893) SENT TO THE SURGERY FOR PEN_TY_20198 BY THE EXTERNAL SUPPLIER, RESULTING IN A DELAY OF LESS THAN 20 MINS. IN THIS CASE, THE SURGEON REPRESENTATIVE PROVIDED A LASER FROM THEIR OWN SUPPLY BUT UNFORTUNATELY THEY ONLY HAD ONE LASER, OPPOSED TO THE TWO LASERS REQUIRED FOR INTENDED USE OF THE CORIN OPTIMIZED POSITIONING SYSTEM. THE CORIN OPTIMIZED POSITIONING SYSTEM IS INTENDED TO BE USED WITH TWO LASERS, ONE DIRECTED FROM THE PATIENT'S ACETABULUM AND ONE FROM ANOTHER POINT IN THE ROOM, THE CONVERGENCE OF WHICH ON THE ROOF OF THE OPERATING THEATRE IS USED TO TRACK THE POSITIONING OF THE ACETABULAR COMPONENT OF A TOTAL HIP ARTHROPLASTY PROCEDURE. IN THIS EVENT, THE SURGERY WAS COMPLETED BY MARKETING THE LASER POSITION ON THE ROOF OF THE OPERATING THEATRE, THEREBY USING THE ACETABULAR DELIVERY SYSTEM IN AN OFF-LABEL MANNER. LASER FAILURE OR OFF-LABEL USE MAY LEAD TO TARGET ORIENTATION BEING COMPROMISED, AND POTENTIAL FOR SUB-OPTIMAL ALIGNMENT OF THE ACETABULAR GUIDE LEADING TO SERIOUS INJURY, SIGNIFICANT PAIN OR REQUIREMENT FOR REVISION SURGERY. IN THIS CASE, POST-OPERATIVE IMAGING WAS REQUESTED BUT NOT PROVIDED BY THE SURGEON REPRESENTATIVE. THE SURGEON REPRESENTATIVE CONFIRMED THAT THE SURGEON WAS CONTENT WITH THE ACHIEVED POSITIONING. THIS REPORT IS FILED WITH THE FDA DUE TO AN EVENT EXPERIENCED WITH A DEVICE THAT IS SIMILAR TO THOSE PLACED ON THE MARKET IN THE USA, HOWEVER, THIS EVENT OCCURRED OUTSIDE OF THE USA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 19209 | CORIN OPTIMIZED POSITIONING SYSTEM | HIP PROSTHESIS | LZO | OPTIMIZED ORTHO PTY LTD | 1248-0052 | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR |