REFLECTION 71362925Recalls & reported problems
Smith & Nephew, Inc. · REFLECTION FLEXIBLE DRILL 25MM · Class 2
Quick summary
This Smith & Nephew flexible drill is a surgical instrument used to drill holes during hip replacement surgery. Most reports describe the drill breaking, cracking, coiling or bending while in use, and in one case a small piece of metal broke off and had to be flushed and suctioned from the surgical site. There are 29 reports, 6 injuries and no deaths, and no recalls name this device. No reports were filed in the past 12 months, compared with 3 in the prior12 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
- 29
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 03596010463272), received between Nov 2, 2018 and Apr 30, 2025 — classified as 6 injuries, 23 malfunctions.
The most frequently reported specific device problem is “Fracture” (18 reports).
2 other recalls cover devices cleared under the same FDA submission (K123598); they may or may not involve this specific model.
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
- Fracture18
- Break8
- Material Twisted/Bent3
- Material Deformation1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions25
- No Consequences Or Impact To Patient2
- Injury1
- Insufficient Information1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 30, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) FLEXIBLE DRILL 25MM BROKE INTRA-OPERATIVELY. A SMALL PIECE OF METAL WAS FOUND AND REMOVED FROM THE SURGICAL SITE. AS THERE WAS ANOTHER VISIBLE SLIVER, THE SURGEON IRRIGATED AND SUCTIONED. THE C-ARM CONFIRMED THAT ALL FOREIGN MATTER WAS REMOVED FROM THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED, AND IF THERE WAS ANY DELAY. NO INJURIES WERE REPORTED AS A RESULT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21938467 ↗MalfunctionFeb 18, 2025Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent
IT WAS REPORTED THAT DURING A THR SURGERY, THE FLEXIBLE DRILL 25MM BENT AND FRACTURED WHILE DRILLING. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE. NO INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21405214 ↗MalfunctionFeb 12, 2025Fracture; Fracture
IT WAS REPORTED THAT, DURING A THR SURGERY, THE FLEXIBLE DRILL 25MM HEAD BROKE OFF WHILE BEING USED IN PATIENT. IT IS UNKNOWN IF ANY PIECE FEEL INSIDE THE PATIENT. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH A S+N BACK-UP DEVICE. NO INJURIES WERE REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21369971 ↗MalfunctionSep 2, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING THR SURGERY, WHEN DRILLING THE HOLES IN THE ACETABULAR COMPONENT, THE DRILL BROKE, WHAT MADE IT NECESSARY TO USE A THICKER DRILL. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20118170 ↗MalfunctionJul 2, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) FLEXIBLE DRILL 25MM WAS BROKEN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19653733 ↗MalfunctionApr 10, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING A THR SURGERY A FLEXIBLE DRILL 25MM FRACTURED. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19085062 ↗MalfunctionApr 10, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING A THR SURGERY A FLEXIBLE DRILL 25MM FRACTURE. THE PROCEDURE WAS PERFORMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19076959 ↗MalfunctionApr 3, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING A THR SURGERY, THE FLEXIBLE DRILL 25MM WAS COILED OR "PIG TAILED", PROVIDED PICTURES SHOW THAT THE FLEXIBLE DRILL 25MM FRACTURED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19033965 ↗MalfunctionApr 3, 2024Fracture; Fracture
IT WAS REPORTED THAT, DURING A THR SURGERY, THE FLEXIBLE DRILL 25MM WAS COILED OR "PIG TAILED", PROVIDED PICTURES SHOW THAT THE FLEXIBLE DRILL 25MM FRACTURED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19033895 ↗MalfunctionApr 3, 2024Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent
IT WAS REPORTED THAT, DURING A THR SURGERY, THE FLEXIBLE DRILL 25MM WAS COILED OR "PIG TAILED", PROVIDED PICTURES SHOW THAT THE FLEXIBLE DRILL 25MM FRACTURED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19033873 ↗MalfunctionNov 14, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING A ACL SURGERY, AT THE END OF MILLING TO USE THE SCREW, ONE (1) FLEXIBLE DRILL 25MM BROKE IN THE FLEXIBLE PART. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18135243 ↗MalfunctionAug 3, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING A THR SURGERY, A FLEXIBLE DRILL 25M WAS NOTICED FRACTURED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17455670 ↗MalfunctionJul 10, 2023Fracture; Fracture
IT WAS REPORTED THAT, DURING A THR SURGERY THE BITS OF (5) FLEXIBLE DRILL 25MM WERE BREAKING AND NOT ABLE FOR USE AFTER ONE HOLE WAS DRILLED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17295373 ↗MalfunctionMay 29, 2023Break; Break
IT WAS REPORTED THAT DURING THR SURGERY, A FLEXIBLE DRILL 25MM BROKE. IT IS UNKNOWN HOW PROCEDURE WAS FINISHED AND IF THERE WAS A DELAY. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THE PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17017247 ↗MalfunctionMay 16, 2023Fracture; Fracture
IT WAS REPORTED THAT, DURING A THR, WHEN DRILLING WITH A FLEXIBLE DRILL 25MM TO PLACE THE SCREW IN THE ACETABULAR CUP, THE DRILL BIT BROKE IN THE FLEXIBLE PART. ADDITIONALLY, NO PIECES FELL INTO THE PATIENT. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16943215 ↗MalfunctionApr 13, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING THR SURGERY AT THE TIME OF DRILLING TO PLACE 6.5MM SCREWS IN ACETABULUM, THE BIT OF A FLEXIBLE DRILL 25MM BROKE. SURGERY WAS RESUMED AFTER A NON-SIGNIFICANT DELAY, WITH BACK-UP S+N DEVICES. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16732233 ↗MalfunctionMar 30, 2023Break; Break
IT WAS REPORTED THAT, DURING A THR SURGERY, WHILE TRYING TO DRILL ON AN ANGLE INTO AN ACETABULAR CUP, ONE (1) FLEXIBLE DRILL 25MM, AND FLEXIBLE DRILL 15MM BROKE, AND ONE (1) FLEXIBLE DRILL 35MM, AND FLEXIBLE DRILL 15MM, TWISTED, BEFORE BEING ABLE TO COMPLETE THE DRILL HOLE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16645328 ↗InjuryFeb 21, 2023Fracture; Fracture
IT WAS REPORTED THAT DURING A THR SURGERY, THE TIP OF THE FLEXIBLE DRILL 25MM DEVICE BROKE DURING USE. THE BROKEN PIECE WAS REMOVED FROM THE PATIENT WITH A PAIR OF SURGICAL TWEEZERS (PICK-UPS). THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED A CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16415081 ↗MalfunctionFeb 15, 2023Fracture; Fracture
IT WAS REPORTED THAT, DURING A PRIMARY THR PROCEDURE, DR. (B)(6) HAD 2 FLEXIBLE DRILL 25MM BREAK OR BEND ON HIM. THE FIRST ONE'S SHAFT SNAPPED IN HALF, AND THE 2ND ONE BENT AT THE END AND WOULD NO LONGER FIT IN THE DRILL GUIDE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16380638 ↗InjuryNov 10, 2022Fracture; Fracture
IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) FLEXIBLE DRILL 25MM DEVICE SNAPPED. THE BROKEN END OF THE FRACTURED DEVICE WAS RETRIEVED FROM THE PATIENT USING FORCEPS. ALL PIECES WERE REMOVED AND ACCOUNTED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15777496 ↗InjuryMay 18, 2022Break; Break
IT WAS REPORTED THAT DURING THR, THE FLEXIBLE DRILL 25MM BROKE WHILE INSIDE THE PATIENT. IT IS UNKNOWN HOW THE PIECES WERE RETRIEVE. THE SURGERY FINISHED WITH THE SAME DEVICE. NO INJURY OR DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14432187 ↗InjuryMay 18, 2022Break; Break
IT WAS REPORTED THAT DURING THR, THE FLEXIBLE DRILL 25MM BROKE WHILE INSIDE THE PATIENT. IT IS UNKNOWN HOW THE PIECES WERE RETRIEVE. THE SURGERY FINISHED WITH THE SAME DEVICE. NO INJURY OR DELAY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14432121 ↗InjuryApr 26, 2022Break; Break
IT WAS REPORTED THAT, DURING A THR SURGERY, A REFLECTION FLEXIBLE DRILL 25MM BROKE PREPARING THE ACETABULUM FOR SCREWS. NO PIECES WERE LEFT BEHIND INSIDE OF THE PATIENT. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14215063 ↗MalfunctionApr 25, 2022Break; Break
IT WAS REPORTED THAT, THE FLEXIBLE DRILL 25MM BROKE. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.
Patient problems: Insufficient Information
MAUDE report 14192189 ↗MalfunctionDec 2, 2020Material Deformation; Material Deformation
IT WAS REPORTED THAT WHILE DRILLING A SCREW HOLE THROUGH A 3 HOLE R3 CUP, THE DRILL BIT BINDED AND BENT IN THE FLEXIBLE AREA. INSTRUMENTS INSIDE PATIENT. S&N BACKUP DEVICE AVAILABLE. NO SURGICAL DELAY OR FURTHER IMPACT TO PATIENT REPORTED DUE THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 10932694 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K123598. One submission often covers many models, so check the product and lot details in each record.
- Z-0730-2019 · Jan 7, 2019 · TerminatedSL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
- Z-1008-2017 · Nov 16, 2016 · TerminatedREFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116
Other Prosthesis, hip, femoral component, cemented, metal devices
- GENESIS II 71440005Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal599 reports
- NA 71364073Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal436 reports
- Peri-Loc 71173377Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal401 reports
- R3 71368569Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal398 reports
- NA 71364006Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal197 reports
- NA 71364011Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal176 reports
- Accord 71360046Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal171 reports
- REFLECTION 71362279Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal155 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.