INSTRUMENT 2107-2200Recalls & reported problems
Howmedica Osteonics Corp. · LINEAR ACTION DRILL CHUCK · Class 2
All models of INSTRUMENT (131)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Howmedica Osteonics linear action drill chuck is a surgical drilling tool used during hip replacement surgery. Most of the 36 reports describe the drill breaking, cracking or bending mid-procedure, sometimes leaving small fragments that had to be washed out of the bone, and in one case a piece of material was left in the patient. Reports note 35 malfunctions and 1 injury, with no deaths. There have been no reports in the past 12 months, and no recalls name this device.
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
- 36
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 07613327212327), received between Oct 17, 2017 and Dec 7, 2022 — classified as 1 injury, 35 malfunctions.
The most frequently reported specific device problem is “Fracture” (22 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 16, 2026.
Most reported problems
Device problems
- Fracture22
- Break9
- Material Deformation3
- Insufficient Device Problem Information2
- Adverse Event Without Identified Device or Use Problem1
- Crack1
- Degraded1
- Device Damaged by Another Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions13
- No Consequences Or Impact To Patient8
- No Known Impact Or Consequence To Patient7
- Insufficient Information6
- Foreign Body In Patient3
- No Patient Involvement2
- Blood Loss1
- Injury1
Recent adverse event reports
The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 7, 2022Fracture; Fracture
BROKE DURING SURGERY. NO BITS FELL OFF INTO PATIENT. 1 MINUTE DELAY WHILST OPENING NEW SET. NO HARM TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15936213 ↗MalfunctionNov 24, 2022Fracture; Fracture
SHAFT BROKE DURING SURGERY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15860576 ↗MalfunctionOct 21, 2022Fracture; Fracture
BROKEN ITEM DURING PROCEDURE. NO BITS BROKEN OFF OR LEFT INSIDE OF PATIENT. DELAY TO SURGERY ¿ MINIMAL WHILST OPENING ANOTHER SET. NO HARM CAME TO PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15648767 ↗MalfunctionSep 12, 2022Fracture; Fracture
SURGEON WAS USING DRILL TO DRILL HOLES FOR SCREWS IN PATIENTS ACETABULUM. THE FLEXIBLE DRILL BROKE. SURGEON WASHED OUT THE HOLE TO REMOVE ANY POTENTIAL SMALL FRAGMENTS LEFT IN HOLE. PRIMARY THA.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15407856 ↗MalfunctionJul 19, 2022Fracture; Fracture
WHEN THE SCREW WAS DRIVEN IN ON THE CUP SIDE, THE BONE WAS HARD AND THE DRILL SHAFT WAS FORCED TO SCREW IN, CAUSING IT TO BEND.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15051272 ↗MalfunctionApr 5, 2022Fracture; Fracture
THE FOLLOWING WAS REPORTED: FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14014680 ↗MalfunctionJan 13, 2022Fracture; Fracture
DURING THA, A DRILL WAS USED TO PLACE A SCREW ON THE ACETABULAR SIDE. THE PATIENT'S BONE WAS HARD AND THE BASE OF THE DRILL SHAFT FRACTURED DURING DRILLING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13248548 ↗MalfunctionDec 2, 2021Fracture; Fracture
THE FOLLOWING WAS REPORTED: DURING THE CASE, FLEX DRILL GUIDE AND DRILL WERE BROKEN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12918013 ↗MalfunctionOct 28, 2021Fracture; Fracture
IT HAS BEEN REPORTED "BREAKAGE PROBABLY DUE TO METAL FATIGUE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 12715758 ↗MalfunctionOct 4, 2021Fracture; Material Fragmentation; Fracture; Material Fragmentation
IT WAS USED TO DRILL THE SCREW NOT IN REVERSE, THE SPRING PART WAS BROKEN APART. NO REMNANT WAS FOUND IN THE BODY ON X-RAY, BUT IT IS UNSURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12567163 ↗MalfunctionAug 13, 2021Fracture; Fracture
IT WAS REPORTED BY THE STAFF NURSE THAT WHILE USING THE FLEXIBLE DRILL TO DRILL FOR SECOND SCREW HOLE, SUDDENLY THE FLEXIBLE DRILL IS BROKEN INTO TWO PIECES. SO COINCIDENTALLY ANOTHER SURGEON IS USING OUR THR SET FOR HIS CASE AS WELL AND HE DONE THE CASE EARLIER THAN THIS SURGEON. SO TSSU MANAGE TO WASH AND AUTOCLAVE BACK THE FLEXIBLE DRILL FROM PREVIOUS CASE FOR THIS CASE BUT THE SURGEON HAVE TO WAIT ANOTHER ONE HOUR JUST TO WAIT FOR THE FLEXIBLE DRILL DONE AUTOCLAVE. SURGICAL DELAY 60 MINUTES. UPDATE 4 MAY 2021 ( ADDITIONAL INFORMATION) : SALES UPDATED THAT - THE SURGEON FEEDBACK THAT THE PATIENT IS NOT SUFFERED FROM ANY ADVERSE CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12317953 ↗MalfunctionAug 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SURGEON WAS DRILLING A HOLE IN CUP HOLE TO INSERT SCREWS, UPON DRILLING SECOND HOLE IT SNAPPED IN THE FLEXIBLE SECTION. THERE WAS NO DEBRIS LEFT IN PATIENT.
Patient problems: Insufficient Information
MAUDE report 12270627 ↗MalfunctionFeb 18, 2021Degraded; Degraded
ACCORDING TO SURGEON, DETERIORATION OVER TIME.
Patient problems: Insufficient Information
MAUDE report 11345324 ↗MalfunctionNov 23, 2020Device Damaged by Another Device; Device Damaged by Another Device
THE CUSTOMER REPORTED THAT THREE DRILL BITS ARE BLUNT. UPDATE: PER SALE REP RESPONSE: "THE SURGEON FEEL THAT THE FLEXIBLE DRILL DRIVER BREAKING MAY BE AS A RESULT OF THE DRILL BIT BEING BLUNT. THE FRAGMENT IN PATIENT ALLEGEDLY COME FROM THE FLEXIBLE DRILL DRIVER. WE DID NOT KNOW ABOUT THIS UNTIL AFTER THE CASE WHEN THE POST OP XRAY SHOWED THE FRAGMENTS OF METAL IN THE HIP." "THERE WAS NO DELAYS TO SURGERY. SURGERY CONTINUED AND FINISHED AS NORMAL."
Patient problems: Foreign Body In Patient
MAUDE report 10883619 ↗MalfunctionOct 21, 2020Fracture; Fracture
THA FOR RIGHT HIP OSTEOARTHRITIS. THE SHAFT BROKE WHILE USING THE DETACHABLE FLEX SHAFT. THE BROKEN DEBRIS (WIRE) REMAINED INSIDE THE BODY (FEMUR SIDE). DOCTORS WANT TO INVESTIGATE THE MATERIAL AND CONFIRM WHETHER THERE IS ANY HEALTH HAZARD AS SOON AS POSSIBLE.
Patient problems: Insufficient Information
MAUDE report 10710008 ↗MalfunctionSep 21, 2020Fracture; Fracture
THE CUSTOMER RETURNED AN IMAGE OF A DETACHABLE FLEX SHAFT SHOWING THAT IT HAD BROKEN INTO TWO PIECES. THE CUSTOMER FURTHER REPORTED THAT SMALL FRAGMENTS OF THE INSTRUMENT WERE NOTICED ON THE POST-OPERATIVE X-RAY. A NEW INSTRUMENT WAS USED TO COMPLETE THE CASE. NO TREATMENT PLANNED TO ADDRESS FRAGMENTS LEFT IN THE PATIENT AS THERE ARE NO ¿ISSUES¿ AT PRESENT WITH PATIENT. DELAY OF 30 SECONDS TO OPEN A NEW INSTRUMENT. LEFT SIDE
Patient problems: Foreign Body In Patient; Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 10562172 ↗MalfunctionAug 5, 2020Fracture; Fracture
DURING THA SURGERY, THE DRILL SHAFT WAS BROKEN. THE WIRE REMAINED INSIDE THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10366462 ↗MalfunctionJul 22, 2020Fracture; Fracture
DURING TOTAL HIP REPLACEMENT SURGERY, THE FLEX. DRILL GUIDE WAS BROKEN WHILE DRILLING FOR ACETABULAR CUP SCREWS. 20 MIN DELAY, RIGHT SIDE. "DURING THE MOUNTING PROCESS OF TOTAL HIP PROTHESIS WHILE SCREWING ACETABULAR CUP, FLEX DRILL GUIDE IS BROKEN".
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 10307928 ↗MalfunctionJul 14, 2020Insufficient Device Problem Information; Insufficient Device Problem Information
2107-2200 THE FLEXIBLE PART OF THE FLEXIBLE DRILL SHAFT WAS DAMAGED DURING USE. SOME MAY HAVE REMAINED IN THE PATIENT. PLEASE REPORT HOW MANY SIMILAR CASES OCCUR EACH YEAR.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10269886 ↗MalfunctionApr 3, 2020Fracture; Fracture
COMPANY REPRESENTATIVE REPORTED THAT "DURING THE CASE, THE ACETABULUM WAS BROKEN WHILE THE DRILL WAS BEING APPLIED. THE SPARE DEVICE WAS NOT USED." UPDATE AS PER FIELD REPRESENTATIVE APRIL 3, 2020: I HAVE ASKED OUR COMPANY REPRESENTATIVE AND THERE WAS NO FRACTURE OF THE PATIENT¿S ACETABULUM. THE FRACTURE WAS ONLY OUR PART.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9921791 ↗MalfunctionFeb 28, 2020Fracture; Fracture
AFTER THE INSTALLATION OF THE TRIDENT CUP, DRILLING WAS PERFORMED USING A DRILL GUIDE TO FIX THE SCREW. THE DRILL TIP WAS BROKEN BECAUSE THE BONE WAS HARD AND DRILLED MANY TIMES. THE PARTS DID NOT FALL INTO THE PATIENT. THE OPERATION WAS CONTINUED AND TERMINATED USING ANOTHER INSTRUMENT. UPDATE: "IT SEEMS THAT IT IS LESS THAN ONE MINUTE BECAUSE THEY JUST CHANGED THE DRILL."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9772197 ↗MalfunctionJan 17, 2020Fracture; Fracture
THE FLEXIBLE SHAFT DRILL WAS BROKEN DURING THE OPERATION. THE PRODUCT WAS EXCHANGED WITH THE SAME NEW ONE. THE PROCEDURE CONTINUED AND COMPLETED WITHOUT PROBLEM. THE REPORTING SURGEON¿S OPINION: DUE TO THE PATIENT¿S BONE QUALITY OR OTHER FACTORS THE DRILL HAD TO BE USED FOR LONG TIME.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9603280 ↗MalfunctionMay 22, 2019Break; Break
UPON INSPECTION WHILE SETTING UP FOR CASE DRILL SHAFTS WERE FOUND TO BE DAMAGED.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8634200 ↗MalfunctionMay 22, 2019Break; Break
UPON INSPECTION WHILE SETTING UP FOR CASE DRILL SHAFTS WERE FOUND TO BE DAMAGED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8633083 ↗MalfunctionMay 16, 2019Break; Break
IT WAS REPORTED THAT " DURING ROBOTIC TOTAL HIP SURGERY, THE PRODUCT WAS BROKEN WHILE SCREWING AFTER THE DOCTOR PUT THE ACETABULAR CUP. PIECES WERE REMOVED BY DOCTOR. AFTER WASHING, THE DOCTOR EXAMINED POSSIBILITY OF BROKEN PIECES ON THE PATIENT BY SIGHT."
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8616968 ↗
Other PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED devices
- PINNACLE 1217-25-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED735 reports
- NA 1365-52-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED683 reports
- APEX 1246-03-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED3 deaths613 reports
- PINNACLE 1217-20-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED2 deaths590 reports
- PINNACLE 1217-30-500Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED1 death484 reports
- NA 1365-53-000Depuy (Ireland) · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED404 reports
- PINNACLE ALTRX 1221-36-054Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED388 reports
- PINNACLE ALTRX 1221-32-050Depuy Orthopaedics, Inc. · PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED386 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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