MAKOPLASTY PARTIAL KNEE END EFFECTOR
Received Feb 18, 2015 · Event occurred Dec 23, 2014
Report 3005985723-2015-00017 · MDR key 4525339
Device
Generic name
Compartmental Knee Prosthesis
Manufacturer
Mako Surgical Corp.Catalog number
111770
Lot number
00491
Product problems
- Break
- Detachment Of Device Component
- Component Falling
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
REPORTED EVENT: THE BALL DETENT FEATURE ON THE END EFFECTOR¿S BURR LATCH WAS NOT FUNCTIONING PROPERLY AT THE END OF THE CASE. THERE WAS NO DELAY TO THE CASE AND THE ISSUE WAS FOUND AFTER THE COMPLETION OF THE CASE. DEVICE EVALUATION AND RESULTS: VISUAL INSPECTION, VISUAL INSPECTION SHOWS DAMAGE AND LOOSENING OF THE BALL DETENT FEATURE ON THE BACK OF THE END EFFECTOR CONSISTENT WITH THE ALLEGED FAILURE. DIMENSIONAL INSPECTION, DIMENSIONAL INSPECTION WAS NOT COMPLETED AS FUNCTIONAL INSPECTION CLEARLY SHOWS THE FAILURE OF THE DEVICE. FUNCTIONAL INSPECTION, FUNCTIONAL INSPECTION SHOWS THE BALL DETENT FEATURE IS NOT FUNCTIONING PROPERLY MAKING IT DIFFICULT TO OPEN AND CLOSE THE BURR LOCKING MECHANISM OF THE END EFFECTOR. DEVICE HISTORY REVIEW: REVIEW OF THE DEVICE HISTORY RECORDS INDICATE 11 DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK ON 11/4/2011. COMPLAINT HISTORY REVIEW: A REVIEW OF COMPLAINTS RELATED TO P/N 111770, S/N (B)(4) SHOWS NO COMPLAINTS RELATED TO THE FAILURE IN THIS INVESTIGATION. TRACKING OF COMPLAINTS RELATED TO THE 111770 PART NUMBER WILL BE TRACKED THROUGH QUARTERLY TREND REQUEST #740. CONCLUSIONS: THIS FAILURE IS CONSISTENT WITH REPEATED USE OF THE DEVICE. AFTER NUMEROUS CASES AND AUTOCLAVE CYCLES, THE BALL DETENT FEATURE MAY BECOME WEAK OR LOOSE INSIDE OF THE END EFFECTOR.
Description of Event or Problem
THE SURGEON PERFORMED A PARTIAL KNEE ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANTS. DURING THE CASE, THE PIECE OF THE END EFFECTOR INSTRUMENT FELL OFF OF THE BACK OF THE PART. THIS DID NOT AFFECT THE CASE OR THE PATIENT. ANOTHER INSTRUMENT WAS USED AND THE BREAKAGE DID NOT AFFECT THE OUTCOME OF THE CASE WHICH WAS SUCCESSFUL.
Additional Manufacturer Narrative
AS PART OF NORMAL COMPLAINT FOLLOW-UP, AN EVALUATION OF THE EVENT HAS BEEN INITIATED AT MAKO SURGICAL. THE EVALUATION IS ONGOING, AND A SUPPLEMENTAL REPORT WILL BE FILED WHEN FURTHER INFORMATION IS OBTAINED.
Description of Event or Problem
THE SURGEON PERFORMED A PARTIAL KNEE ARTHROPLASTY USING THE ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM (RIO) AND RESTORIS MULTICOMPARTMENTAL KNEE (MCK) IMPLANTS. DURING THE CASE, THE PIECE OF THE END EFFECTOR INSTRUMENT FELL OFF OF THE BACK OF THE PART. THIS DID NOT AFFECT THE CASE OR THE PATIENT. ANOTHER INSTRUMENT WAS USED AND THE BREAKAGE DID NOT AFFECT THE OUTCOME OF THE CASE WHICH WAS SUCCESSFUL.