REFLECTION 71362935Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 03596010464668), received between Jul 27, 2017 and Sep 2, 2025 — classified as 4 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Fracture” (12 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THR SURGERY ONE (1) FLEXIBLE DRILL 35 MM WAS DAMAGED, IT FRACTURES DUE TO THE ANGULATION AND HARDNESS OF THE PATIENT'S BONE. ALL MATERIALS WERE REMOVED. 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 22935340 ↗
• MalfunctionAug 10, 2025Use of Device Problem; Dull, Blunt; Use of Device Problem; Dull, Blunt

  IT WAS REPORTED THAT DURING A THR SURGERY, THE FLEXIBLE DRILL 35MM BECAME DULL, BURNED THE BONE, AND RELEASED A BLACK RESIDUE. IT WAS WASHED WITH SALINE SOLUTION, AND ALL RESIDUE WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE REPORTED. NO DAMAGE WAS CAUSED, AND THE PATIENT'S HEALTH CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22767972 ↗
• MalfunctionMar 25, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A DEMONSTRATION/TRAINING SESSION FOR A THR SURGERY, ONE (1) FLEXIBLE DRILL 35MM BROKE WHILE DRILLING TO FIX THE SCREW. THE FRAGMENT WAS REMOVED. 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 21694103 ↗
• MalfunctionDec 2, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR, WHEN SURGEON WAS DRILLING TO PLACE THE SCREWS, THE FLEXIBLE DRILL 35MM BROKE IN THE ACETABULUM. BREAKAGE DID NOT HAPPENED INTO PIECES. IT WAS COMPLETELY REMOVED. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20819088 ↗
• MalfunctionJul 11, 2024Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING THA, A FLEXIBLE DRILL 35MM BENT AND BROKE OFF INSIDE THE PATIENT, MAKING IT UNUSABLE. THE PIECE WAS REMOVED COMPLETELY FROM THE PATIENT. THERE WAS NO DELAY AND THE PROCEDURE WAS FINISHED USING THE SAME DEVICE. NO PATIENT INJURY WAS REPORTED AS CONSEQUENCE OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19727399 ↗
• MalfunctionMar 12, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT, DURING SET UP OR INSPECTION FOR A THR, THE PACKAGE ONE (1) FLEXIBLE DRILL 35MM SEEMED PERFECT BUT WHEN IT WAS OPENED, THE PROTECTIVE INNER PACKAGE WAS BROKEN AND COMPROMISED. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. SINCE INCIDENT OCCURRED BEFORE PROCEDURE; PATIENT WAS NOT YET INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18888458 ↗
• InjuryJan 11, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY, ONE (1) FLEXIBLE DRILL 35MM BIT BROKE OFF IN THE PATIENT WHILE DRILLING A HOLE FOR A SCREW. THE SURGEON DECIDED AT HIS OWN DISCRETION TO LEAVE THE BROKEN PIECE OF THE DRILL IN THE PATIENT'S BONE AFTER ATTEMPTING TO RETRIEVE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18490771 ↗
• MalfunctionJul 25, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR, A FLEXIBLE DRILL 35MM BROKE. FURTHERMORE, THE BROKEN PIECES WERE REMOVED FROM THE PATIENT WITH A HEMISTAT. SURGERY WAS RESUMED. WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17393164 ↗
• MalfunctionFeb 14, 2023Fracture; Unraveled Material; Fracture; Unraveled Material

  IT WAS REPORTED THAT, DURING A THR, THE SHAFT OF THE FLEXIBLE DRILL WAS UNRAVELING. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A COMPETITOR DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16372242 ↗
• MalfunctionJan 4, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR, ONE (1) FLEXIBLE DRILL 35MM BIT SPUN OUT AND COIL BROKE MAKING THE DRILL BIT UNUSABLE. 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 16099203 ↗
• MalfunctionDec 27, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A LEFT THA, THE DRILL WAS STRESSED AT A DIFFICULT ANGLE OF DRILLING AND THE DRILL BIT OF A FLEXIBLE DRILL 35MM BROKE. IT IS UNKNOWN IF ANY FRAGMENT REMAINS IN THE PATIENT, HOW THE PROCEDURE WAS RESUMED, FOR HOW LONG IT WAS DELAYED AND IF THERE WAS ANY CONSEQUENCE TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16055242 ↗
• InjuryOct 29, 2022Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING SURGERY, FLEXIBLE DRILL 35MM BENT AND FRACTURED. IT IS UNKNOWN HOW PIECES WERE RETRIEVED. SURGERY WAS NOT DELAYED. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15697154 ↗
• MalfunctionMay 11, 2021Break; Naturally Worn; Break; Naturally Worn

  IT WAS REPORTED THAT DURING THR, THE FLEXIBLE DRILL 35MM BROKE OUTSIDE THE PATIENT DUE TO WEAR AND TEAR. A SMITH AND NEPHEW DEVICE WAS AVAILABLE. NO INJURY OR SIGNIFICANT DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11810105 ↗
• InjuryMay 6, 2021Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE FLEXIBLE DRILL 35 MM BROKE DURING INSTALLATION OF A R3 CUP. AFTER THE OPERATION, IT WAS FOUND THAT A FRAGMENT OF THE FLEXIBLE DRILL 35 MM REMAINED INSIDE THE PATIENT. NO DELAYS WERE REPORTED AND THE PROCEDURE WAS FINISHED WITH A SMITH AND NEPHEW BACK UP DEVICE. IT IS UNKNOWN IF THE PIECE OF THE BROKEN DEVICE WAS RETRIEVED FROM THE PATIENT. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 11783596 ↗
• MalfunctionApr 18, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE FLEXIBLE DRILLS USED TO DRILL HOLES FOR REDAPT CUP FIXATION BENT DUE TO HARD BONE AND DIFFICULT ANGLE TRAJECTORY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A COMPETITOR DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683518 ↗
• MalfunctionApr 18, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE FLEXIBLE DRILLS USED TO DRILL HOLES FOR REDAPT CUP FIXATION BENT DUE TO HARD BONE AND DIFFICULT ANGLE TRAJECTORY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A COMPETITOR DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683517 ↗
• MalfunctionMar 8, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING SURGERY, INSIDE THE PATIENT, OF THE REDAPT DRILL GUIDE. IT WAS ADVISED THAT THE DRILL GUIDE WAS FULLY SEATED WITHIN THE SCREW HOLE TO AVOID DAMAGING THE TABS ACCORDING TO SURGICAL TECHNIQUE. BUT THIS WAS FOUND TO CREATE DIFFICULTIES IN SEEING THE DRILL BIT AND KNOWING IF IT WAS FULLY SEATED IN THE BONE WITHIN THE DRILL GUIDE TO BE READY TO DRILL. WHEN HE FELT RESISTANCE HE THOUGHT THE BIT MUST BE SITTING ON THE BONE, SO HE BEGAN TO DRILL, BUT FOUND THAT IT REALLY WAS NOT AND THIS CAUSED THE BIT TO BEND WITHOUT DRILLING THE BONE. THE PROCEDURE FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. SURGICAL DELAY LESS THAN 30 MINUTES. PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11431004 ↗
• InjuryJan 28, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING SURGERY, WHILE DRILLING WITH THE FLEXIBLE DRILL 35MM AN EVENT OCCURRED AND PROCEDURE WAS CONCLUDED WITH A 25MM FLEXIBLE DRILL AND WITHOUT A DELAY. PATIENT WAS NOT HARMED BEYOND THE DESCRIBED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11242556 ↗
• MalfunctionDec 30, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY, THE 35MM DRILL BIT WAS BEING USED TO DRILL THROUGH THE R3 CUP TO PLACE A SCREW INTO THE CUP WHEN IT BROKE INTO MULTIPLE PIECES INSIDE THE PATIENT. ALL THE PIECES WERE RECOVERED. THERE WAS AN S&N BACKUP AVAILABLE. THERE WERE NO DELAYS IN THE PROCEDURE AND NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9533553 ↗
• MalfunctionDec 3, 2019Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY, THE 35MM DRILL BIT UNWOUND ITSELF AND GOT BENT WHILE DRILLING THE HOLES IN THE R3 CUP. NO INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9400871 ↗
• MalfunctionNov 13, 2019Break; Break

  IT WAS REPORTED THAT THE DRILL BIT BROKE DURING SURGERY. THE DEVICE BROKE INSIDE THE PATIENT BUT NO PIECES FELL INSIDE, ALL THE PIECES WERE RECOVERED. NO SURGICAL INTERVENTION WAS REQUIRED. NO DELAY NOR INJURY REPORTED. A S&N BACKUP DEVICE WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9318679 ↗
• MalfunctionOct 1, 2019Break; Break

  IT WAS REPORTED THAT DURING PROCEDURE THE SURGEON STARTED TO DRILL FOR SCREW AND DRILL SNAPPED AND BENT COMPLETELY SIDEWAYS. BACKUP DEVICE AVAILABLE. NO MORE INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9142517 ↗
• MalfunctionSep 30, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY WHEN THE PHYSICIAN WAS DRILLING THE ACETABULUM THE FLEXIBLE DRILL BROKE, ALL PIECES OF DRILL BIT WERE RETAINED, A NEW DRILL BIT WAS OPENED AND THE SURGERY WENT ON WITHOUT INCIDENT. UNKNOWN IF THERE WAS A DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9137597 ↗
• MalfunctionJun 24, 2019Break; Break

  IT WAS REPORTED THAT DURING PROCEDURE, THE FLEXIBLE DRILL OVERHEATED AND BROKE. A DELAY OF OVER 30MIN WAS REPORTED. NO INJURY REPORTED. A BACK UP DEVICE WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8727935 ↗
• MalfunctionSep 7, 2018Break; Break

  IT WAS REPORTED THAT THE DRILL BROKE AT THE SPRING SECTION DURING DRILLING. THE DRILL WAS ENGAGED IN THE R3 SHELL SCREW HOLE WHEN IT BROKE, THE BROKEN PIECE WAS RETRIEVED.

  Patient problems: No Information

  MAUDE report 7855983 ↗

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 · Terminated
  SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
• Z-1008-2017 · Nov 16, 2016 · Terminated
  REFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116