MOUNTAINEER 288301024Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034221151), received between Jun 23, 2017 and Jan 22, 2020 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 22, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DRILL WAS RECEIVED WITH AN UNKNOWN ALLEGATION. THE PATIENT AND PROCEDURE INVOLVEMENT WERE UNKNOWN. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9617295 ↗
• MalfunctionJun 24, 2019Break; Break

  IT WAS REPORTED THAT THE SPINE FUSION SURGERY WAS PERFORMED ON (B)(6) 2019 DUE TO DENS FRACTURE AT C2. DURING THE SURGERY, WHEN THE SURGEON PERFORMED DRILLING AT C1 LATERAL MASS WITH ADJUSTABLE DRILL (P/N: 288301024) TO CREATE SCREW HOLE, IT WAS REPORTED THAT THE DRILL BIT WAS BROKEN. THERE WERE NO BROKEN PARTS IN THE PATIENT¿S BODY. THE SURGERY WAS FINISHED WITHOUT ANY OTHER PROBLEM ALTHOUGH IT WAS NOT REPORTED HOW THE SURGERY WAS COMPLETED. THERE WAS LESS THAN 30 MIN. SURGICAL DELAY AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED BY THE HOSPITAL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8729716 ↗
• MalfunctionApr 18, 2018Break; Break

  DATE J&J BECAME AWARE: (B)(4) 2018. DATE OF EVENT: (B)(6) 2018 NAME OF REPORTER: (B)(6). HOSPITAL NAME: (B)(6). HOSPITAL TOWN: (B)(6) . PRODUCT: MOUNTAINEER ADJUSTABLE DRILL BIT. LOT/BATCH/EXP: - 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? HAD TO REMOVE PIECE OF BROKEN DRILL FROM THE BONE OF THE PATIENT. 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 PLEASE GIVE A DETAILED EXPLANATION OF THE EVENT: DRILLING INTO THE PATIENTS BONE TO PREP FOR A SCREW, HAS DRILLING THE DRILL BIT SNAPPED INTO THE PATIENTS BONE AND REMAINED IN THE BONE. HAS TO BE REMOVED. WAS A CRITICAL PATIENT IN A TRAUMA CASE. BROKEN PIECE HAS BEEN REMOVED FROM PATIENT.

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

  MAUDE report 7440907 ↗
• MalfunctionJun 23, 2017Break; Break

  THERE ARE 100+ ITEMS PLACED ON DC ORTHOKIT QUARANTINE DUE TO BREAKAGES, FUNCTIONAL TESTS FAILURES. THIRTY EIGHT PERTAIN TO DEPUY SPINE PRODUCTS. IN ALL CASES NO DATA AVAILABLE IF ANY INJURES OR ADVERSE EVENTS. NO INFORMATION ABOUT SURGERY, DELAYS, PATIENT RELATED DATA. ONLY PRODUCT CODE/LOT DESCRIPTION AND BREAKAGE DEFINITION IS AVAILABLE. QI# (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6663122 ↗