1723170-2015-00375
Report
- Report Number
- 1723170-2015-00375
- Event Type
- Malfunction
- Date Received
- March 27, 2015
- Date of Event
- February 27, 2015
- Report Date
- February 23, 2016
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
CORRECTION TO LOT # AND PART NUMBER. ACTUAL PART RECEIVED: INSTRUMENT 9339082 MOD QC RATCHET HNDL. LOT # PR05L008.
FURTHER REVIEW OF THE PART NUMBER, AND LOT NUMBER, OF THE RETURNED DEVICE FOUND THAT THE DEVICE WAS MANUFACTURED BY A DIFFERENT MEDTRONIC FACILITY. THE COMPLAINT WAS FORWARDED TO THE FACILITY FOR INVESTIGATION. AS THE DEVICE WAS A NOT MANUFACTURED BY MEDTRONIC NAVIGATION, INC., THIS ISSUE WILL NOT BE DOCUMENTED IN A MEDTRONIC NAVIGATION HARDWARE ANOMALY TRACKING DATABASE.
CORRECTION: IT WAS DISCOVERED ON 27-JAN-2016, THAT AN INCORRECT DATE WAS REFERENCED IN A PREVIOUS SUPPLEMENTAL 3500A SUBMISSION. THE REPORTED DATE OF 16-AUG-2016 WAS REPORTED INCORRECTLY AND SHOULD BE 16-AUG-2015.STATEMENT IN PREVIOUS SUPPLEMENTAL 3500A SUBMISSION SHOULD READ: ¿ON 30-JUN-2015, IT WAS NOTICED THAT A CODING ERROR IN MDR SUBMISSIONS FROM OUR FACILITY RESULTED IN THE MAUDE DATABASE INCORRECTLY CODING THE DEVICES RELATED TO OUR MDR SUBMISSIONS FROM 25-MAY-2015 TO 16-AUG-2015. THE DECISION TO WAIT UNTIL THE DATABASE WAS CORRECTED WAS MADE AFTER CONSULTATION WITH THE FDA AS ADVISED BY A CONSUMER SAFETY OFFICER WITH THE INFORMATION ANALYSIS BRANCH, DIVISION OF POST MARKET SURVEILLANCE, OFFICE OF SURVEILLANCE AND BIOMETRICS. AN IT SOLUTION WAS IMPLEMENTED ON 16-AUG-2015. THIS MDR WAS SUBMITTED TO CORRECT THE CODING ERROR. THERE IS NO NEW INFORMATION TO CHANGE THE PATIENT INFORMATION, EVENT DESCRIPTION AND/OR MANUFACTURER NARRATIVE THAT WAS PREVIOUSLY REPORTED.¿
PATIENT INFORMATION WAS NOT MADE AVAILABLE FROM THE SITE. PRODUCT IS CLASS I FOR US REGULATIONS AND DOES NOT REQUIRE A 510(K) DESIGNATION. DEVICE MANUFACTURING DATE IS UNAVAILABLE. RETURN REQUESTED. NO PARTS HAVE BEEN RECEIVED BY MANUFACTURER FOR ANALYSIS. (B)(4) 2015 - A MEDTRONIC REPRESENTATIVE, FOLLOWING-UP AT THE SITE, REPORTED A LOCAL MEDTRONIC REPRESENTATIVE PROVIDED A SMALLER GRAY EGG-SHAPED HANDLE TO THE SITE AND RECOMMENDED THEY USE IT INSTEAD OF THE RATCHETING HANDLE THEY HAD BEEN USING. THERE HAVE BEEN NO REPORTED ISSUES WITH USING THIS NEW HANDLE DESIGN. THE MEDTRONIC REPRESENTATIVES WERE NOT ALLOWED TO REMOVE THE SUSPECT HANDLE FROM THE SITE. (B)(4).
ANALYSIS OF SUSPECT INSTRUMENT AS FOLLOWS: UNABLE TO DETERMINE THE AGE OF THE HANDLE BUT IT APPEARS TO BE WELL WORN. AS REPORTED, THE RATCHETING MECHANISM HAS BROKEN LOOSE AND IS NO LONGER FUNCTIONAL. OTHERWISE, THE HANDLE RECEIVES INSTRUMENTS WITHOUT ISSUE. THE END CAP IS STILL INTACT. THIS ISSUE WILL BE TRENDED AND MONITORED IN A MEDTRONIC HARDWARE ANOMALY TRACKING DATABASE. A REPLACEMENT INSTRUMENT WAS SENT TO THE SITE FOR ISSUE RESOLUTION.
A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SPINAL FUSION PROCEDURE, WHEN THE SURGEON WAS MALLETING THE BACK OF THE RATCHETING HANDLE, THE HANDLE WAS STARTING TO BREAK. THE SITE SAW THE INSTRUMENT WAS ABOUT TO BREAK AND STOPPED USE OF THAT HANDLE. A SECOND HANDLE WAS BROUGHT IN AND USED TO CONTINUE THE PROCEDURE WITH NO DELAY. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |