SUMMIT 274641000Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10705034192918), received between Dec 19, 2017 and Feb 6, 2020 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2020Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE, DURING SURGERY, THE SURGEON ATTEMPTED TO CUT THE OVERHANG OF A 3.5MM ROD INSITU AFTER FINAL TIGHTENING WAS ALREADY PERFORMED ON A C3 - C7 CONSTRUCT. THE OVERHANG WAS LOCATED AT THE C3 LEVEL. THE TIP OF THE ROD CUTTER BROKE APART INTO THE PATIENT. THE SURGEON WAS ABLE TO LOCATE AND REMOVE ALL BROKEN PIECES AND CONTINUED WITH THE SURGERY. FRAGMENTS GENERATED IS UNKNOWN. SURGICAL DELAY IS UNKNOWN. THERE WERE NO PATIENT CONSEQUENCES. THE PROCEDURE OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN ROD (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS 1 OF 1 REPORT FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9677974 ↗
• MalfunctionAug 6, 2019Break; Break

  TO WHOM IT MAY CONCERN: DATE J&J BECAME AWARE: 16/07/19. (B)(6). PRODUCT: MOUNTAINEER ROD CUTTER. LOT/BATCH/EXP: KM646313. PRODUCT NUMBER: 274641000. DID THE EVENT HAPPEN DURING A PROCEDURE? YES. WERE YOU IN THE PROCEDURE AT THE TIME OF THE EVENT? YES. WAS THE PRODUCT BEING USED IN A CLINICAL TRIAL? NO. EVENT OUTCOME/HOW WAS IT MANAGED? ANOTHER KIT OPENED FOR REPLACEMENT INSTRUMENTS WAS THERE A PATIENT IMPACT OR WAS THE PROCEDURE DUE TO THE FAILURE? NO. HAS THE REPORTER FACILITY INDICATED THERE MAY BE LEGAL ACTION? NO. IS THE PRODUCT AVAILABLE FOR RETURN? YES ONCE CLEANED. PLEASE GIVE A DETAILED EXPLANATION OF THE EVENT: THE SURGEON WENT TO CUT THE ROD WITH THE ROD CUTTER AND AS DOING SO, THE CUTTER SNAPPED AT THE JAWS. SURGERY DELAYED BY 5 MINS WHILE ANOTHER KIT WAS OPENED FOR A REPLACEMENT INSTRUMENT. PLEASE CAN YOU SEND AN URGENT REPLACEMENT TO: PRODUCT CODE 274641000. (B)(6). THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8865722 ↗
• MalfunctionFeb 2, 2018Break; Break

  IT WAS REPORTED SURGEON WAS TRYING TO CUT A ROD AFTER IT WAS LOCKED DOWN IN THE OCCIPITAL PLATE. HE PUT THE CUTTER ON THE ROD AND ATTEMPTED TO CUT IT. THE CUTTER BROKE AND DIDN¿T CUT ROD. THE CUTTER FRAGMENT WAS RETRIEVED AND DISPOSED. HE THEN GOT A METAL CUTTING BURR AND CUT ROD. TEN MINUTE DELAY REPORTED.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 7238041 ↗
• MalfunctionJan 23, 2018Break; Break

  ROD CUTTER WAS LEFT IN STERILE CORE AFTER IT HAD BEEN REMOVED FROM THE MOUNTAINEER INSTRUMENT SET. WE WERE NOT PRESENT DURING A CASE WHERE THIS INSTRUMENT WAS BROKEN, NOR DID ANY HOSPITAL STAFF HAVE ANY KNOWLEDGE OF THIS INSTRUMENT BREAKING. THE TIP OF THE CUTTER BROKE OFF AND WE DO NOT HAVE THIS PIECE IN OUR POSSESSION. PATIENT CONSEQUENCE? :NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? : YES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7211762 ↗
• MalfunctionDec 19, 2017Break; Break

  INSTRUMENT BROKEN IN TWO PARTS WAS DELIVERED DIRECT TO PRODUCT SAFETY (B)(6) 2017 FROM (B)(6) HOSPITAL WITH NO COMPLAINT ATTACHED. JNJ REP BECAME AWARE OF MISSING ITEM (B)(6) 2017 AND OBTAINING THE FOLLOWING DETAILS FROM CUSTOMER: THE ROD CUTTER WAS BROKEN WHEN A REGISTRAR WAS USING IT TO CUT A ROD INSITU (ALREADY IN A PATIENT). FROM WHAT JNJ REP KNOWS THE ROD WAS NOT A MOUNTAINEER ROD. THE REGISTRAR WAS HAVING DIFFICULTY AND THE STAFF WERE LOOKING FOR AN INSTRUMENT TO CUT THE ROD INSITU. IT WAS BROKEN IN THE PROCESS. THE ROD CUTTER BELONGS ON A CONSIGNED MOUNTAINEER. IMAGE OF BROKEN INSTRUMENT AS RECEIVED (B)(6) 2017 ON FILE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7130628 ↗