SOLUTION SYSTEM 2108-04-000Recalls & reported problems
Depuy Orthopaedics, Inc. · SOLUTION SYSTEM CEMENT PLUG DRILL 4.5mm DIA · Class 1
Quick summary
This DePuy cement plug drill is a surgical drill bit. The 24 reports mostly describe the drill or its tip breaking during surgery, sometimes leaving a fragment in the patient. There were 2 injuries and no deaths. No recalls name this device, and reports rose from 1 in the previous 12 months to 3 in the latest 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 24
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10603295086932), received between Oct 12, 2017 and Jun 12, 2026 — classified as 2 injuries, 22 malfunctions.
The most frequently reported specific device problem is “Break” (23 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.
Reports received per month
Most reported problems
Device problems
- Break23
- Entrapment of Device3
- Illegible Information1
- Material Deformation1
- Material Fragmentation1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- No Consequences Or Impact To Patient6
- Foreign Body In Patient3
- Insufficient Information3
- Not Applicable3
- No Information1
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 12, 2026Break
IT WAS REPORTED THAT THE ITEM BROKE WHILE INSIDE A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25485417 ↗MalfunctionMay 21, 2026Break; Entrapment of Device
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: Foreign Body In Patient
MAUDE report 25241378 ↗MalfunctionFeb 25, 2026Break
IT WAS REPORTED THAT DRILL BIT BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24445834 ↗MalfunctionJul 1, 2025Break; Entrapment of Device; Break; Entrapment of Device
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: Foreign Body In Patient
MAUDE report 22374013 ↗MalfunctionAug 21, 2024Break; Break
IT WAS REPORTED THAT THE DRILL BIT BROKE IN FEMUR TRYING TO REMOVE CEMENT.
Patient problems: Insufficient Information
MAUDE report 20017895 ↗MalfunctionApr 9, 2024Break; Break
IT WAS REPORTED THAT THE TIP OF SOLUTION DRILL BIT BROKE OFF DURING SURGERY. ALL PIECES WERE RECOVERED. SURGICAL DELAY WAS UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 19069796 ↗MalfunctionMar 27, 2024Break; Break
IT WAS REPORTED THAT SOLUTION REAMER WAS BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18988642 ↗MalfunctionJan 18, 2024Break; Break
IT WAS REPORTED THAT THE TIP OF THE DRILL BIT BROKE INTRA SURGERY. THEY RETRIEVED THE BROKEN PART. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? --> NO, WAS PROCEDURE SUCCESSFULLY COMPLETED? --> YES, WERE FRAGMENTS GENERATED? --> NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18534257 ↗MalfunctionSep 21, 2023Break; Break
IT WAS REPORTED THAT THE DRILL BIT THE TIP BROKE INTERMEDULLARY. THE SURGEON BROUGHT IN X RAY & WAS ABLE TO EXTRACT THE PIECE FROM THE FEMUR. THERE WAS A 5 MINUTE DELAY & NO HARM CAME TO PATIENT. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? : UNKNOWN, IF YES, NUMBER OF MINUTES?: 10, ACTION TAKEN WHEN EVENT OCCURRED?: X RAY CALLED AND BROUGHT INTO ROOM, WAS PROCEDURE SUCCESSFULLY COMPLETED?: YES, WERE FRAGMENTS GENERATED?: YES, IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION?: YES, 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, IP: (B)(4). 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 17790726 ↗MalfunctionJul 28, 2023Break; Break
IT WAS REPORTED THAT THE 4.5MM DRILL BROKE. ALL PIECES WERE RETRIEVED. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17419090 ↗MalfunctionDec 30, 2021Break; Break
ADDITIONAL INFORMATION RECEIVED STATES THAT IT WAS CLOSE TO THE TIP THAT BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13117283 ↗MalfunctionSep 15, 2021Break; Break
ADDITIONAL INFORMATION RECEIVED STATES THAT THE ITEM BROKE INTO 2 PIECES. THE LARGE PIECE HAS BEEN RETURNED. THE REMAINDER WAS DISCARDED AFTER THE CASE BY THE HOSPITAL STAFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12474458 ↗MalfunctionAug 5, 2021Break; Break
IT WAS REPORTED THAT THE TIP OF THE CEMENT DRILL BROKE OFF. SURGICAL DELAY OF 3 MINUTES.
Patient problems: Insufficient Information
MAUDE report 12279904 ↗MalfunctionApr 9, 2021Material Deformation; Material Deformation
SOLUTION DRILL WAS BENT INTRA-OP WHILST SURGEON WAS ATTEMPTING TO USE IN FEMORAL CANAL. THERE WAS NO INCIDENT WITH PATIENT. INSTRUMENT WAS DEEMED IRREPARABLE AND A NEW ONE WAS ORDERED. THERE IS NO OTHER INFORMATION TO BE OBTAINED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11641278 ↗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 10504942 ↗MalfunctionAug 26, 2020Break; Illegible Information; Break; Illegible Information
ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE LOT NUMBERS WERE ILLEGIBLE ON THE DRILL. THE BROKEN PIECE WAS REMOVED FROM THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10453981 ↗MalfunctionMar 4, 2020Break; Break
IT WAS REPORTED THAT THINSHAFT 4.5 DRILL BROKE DURING SURGERY PLEASE REPLACE TO (B)(6). NO SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9788006 ↗MalfunctionNov 22, 2019Break; Break
IT WAS REPORTED THAT THE DRILL BROKE DURING CANAL REAMING. THERE WAS 10 MINUTES SURGICAL DELAY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9362871 ↗InjuryJul 24, 2019Break; Entrapment of Device; Break; Entrapment of Device
IT WAS REPORTED THAT DURING HIP REVISION, A DRILL BIT BROKE OFF INSIDE THE FEMORAL CANAL OF THE PATIENT AND THE SURGEON WAS UNABLE TO RETRIEVE. THERE WAS A 1 HOUR SURGICAL DELAY.
Patient problems: Not Applicable
MAUDE report 8823538 ↗MalfunctionFeb 13, 2019Break; Break
DURING A REVISION OF A FAILED FEMORAL STEM THE SURGEON NEEDED TO IMPLANT A REVISION FEMORAL STEM, THERE A DENSE SCLEROTIC BONE. THE SURGEON TEMPTED TO REAM THROUGH THE HARD BONE IN ORDER TO PASS A REVISION STEM. DURING REAMING THE DISTAL TIP BECAME BOUND IN THE CANAL AND SHEARED OFF.
Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient
MAUDE report 8336944 ↗MalfunctionSep 18, 2018Break; Break
IT WAS REPORTED THAT THE TIP OF THE REAMER WAS BROKE OFF DURING SURGERY. ALL THE PIECES WERE RECOVERED FROM THE PATIENT. THERE WAS 5 MINUTES SURGICAL DELAY REPORTED.
Patient problems: Not Applicable
MAUDE report 7886930 ↗MalfunctionAug 15, 2018Break; Material Fragmentation; Break; Material Fragmentation
ITEM BROKE DURING SURGERY - MORELAND INSTRUMENT SET.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7786259 ↗InjuryDec 22, 2017Break; Break
HIP REVISION, SURGEON: (B)(6), (B)(6) 2017. DURING CEMENT REMOVAL OF HIP REVISION. ATTEMPTING TO REMOVE CEMENT PLUG, DRILLED INTO CEMENT AND BROKE ON THE VERY FIRST USE. ACTION TAKEN TO MANAGE PROBLEM: HAD TO DO ETO (AND CABLES) TO REMOVE BROKEN DRILL BIT. 45 MINUTE DELAY TO PROCEDURE.
Patient problems: Not Applicable
MAUDE report 7141792 ↗MalfunctionOct 12, 2017Break; Break
IT WAS REPORTED THAT A REAMER TIP BROKE DURING THE SURGERY.
Patient problems: No Information
MAUDE report 6944555 ↗
Other BIT, DRILL devices
- QUICKSET 2274-25-500Depuy Orthopaedics, Inc. · BIT, DRILL1,985 reports
- QUICKSET 2274-35-500Depuy Orthopaedics, Inc. · BIT, DRILL770 reports
- QUICKSET 2274-30-500Depuy Orthopaedics, Inc. · BIT, DRILL761 reports
- NA 03.037.022Synthes GmbH · BIT, DRILL339 reports
- NA 323.062Synthes GmbH · BIT, DRILL309 reports
- QUICKSET 2274-56-000Depuy (Ireland) · BIT, DRILL275 reports
- QUICKSET 2274-45-500Depuy Orthopaedics, Inc. · BIT, DRILL211 reports
- LCS 2366-83-000Depuy (Ireland) · BIT, DRILL207 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.