SOLUTION SYSTEM 2108-06-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295086949), received between Mar 2, 2018 and May 21, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2026Break

  TWO REAMER TIPS FROM THE FEMORAL REV ALLOGRAFT BROKE OFF IN THE PATIENT¿S FEMUR. ONE WAS RETRIEVED. HEALTHCARE PROFESSIONAL ORDER XRAY TO CONFIRM PLACEMENT OF THE SECOND ONE AND WAS UNABLE TO RETRIEVE THE REAMER TIP FROM THE PATIENT¿S FEMUR. THE PROCEDURE WAS CONTINUED AND THE FEMORAL STEM IMPLANTED TO COMPLETE THE PROCEDURE AS INTENDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25241367 ↗
• MalfunctionApr 6, 2026Break

  IT WAS REPORTED THAT 6 MM SOLUTION REAMER BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24791627 ↗
• MalfunctionAug 5, 2025Break; Break

  IT WAS REPORTED THAT DRILL BIT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22720034 ↗
• MalfunctionJul 1, 2025Break; Break

  IT WAS REPORTED THAT THE SOL SYS CEM PLUG DRILLS 6.0MM WAS BROKEN AND RETRIEVED. SOL SYS CEM PLUG DRILLS 4.5MM WAS BROKEN AND NOT RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22374636 ↗
• MalfunctionJan 28, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT THE DRILL BIT BROKE INSIDE PATIENT.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 21256465 ↗
• MalfunctionJun 13, 2022Break; Break

  IT WAS REPORTED THAT TIP OF REAMER BROKE IN FEMORAL CANAL AS SURGEON WAS REAMING. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14674166 ↗
• MalfunctionSep 30, 2021Break; Break

  WHEN USING THE CEMENT PLUG DRILL, 6MM, THE DRILL BROKE. THE BROKEN END WAS IMMEDIATELY RECOVERED. NO FRAGMENTS GENERATED. CASE MOVED FORWARD. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO, ACTION TAKEN WHEN EVENT OCCURRED? BROKEN BIT REMOVED FROM CEMENT MANTLE, CASE PROCEEDED, WAS PROCEDURE SUCCESSFULLY COMPLETED? YES, WERE FRAGMENTS GENERATED? NO, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN, PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN. (B)(6): DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12557774 ↗
• MalfunctionSep 8, 2020Break; Break

  IT WAS REPORTED THAT THE REAMER TIPS WAS BROKEN OFF. ALL PARTS RECOVERED. NO IMPACT ON SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10504928 ↗
• MalfunctionOct 23, 2019Break; Entrapment of Device; Break; Entrapment of Device

  TIP OF DRILL BROKE OFF AND BECAME LODGED IN PATIENT¿S FEMORAL CANAL. OCCURRED DURING SURGERY, RESULTED IN NO DELAY. ITEM DID BREAK INTO 2 PIECES, ONLY MAIN SHAFT OF DRILL WAS RETRIEVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9226227 ↗
• MalfunctionMar 2, 2018Bent; Bent

  IT WAS REPORTED THAT, UPON INSPECTION DRILL IS BENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7309158 ↗