REFLECTION 71362279Recalls & reported problems

Summary

The FDA's MAUDE database contains 155 adverse event reports that list this exact device (DI 03596010456519), received between Feb 22, 2019 and Jun 22, 2026 — classified as 11 injuries, 144 malfunctions.

The most frequently reported specific device problem is “Break” (94 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 155 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2026Fracture

  IT WAS REPORTED THAT, DURING A THA SURGERY, ONE (1) REAMER HANDLE BROKE AND PART DISASSOCIATED WHEN REAMING. NO PIECES FELL INTO THE PATIENT'S ANATOMY. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25573118 ↗
• MalfunctionMay 11, 2026Fracture

  IT WAS REPORTED THAT DURING A THR, THE SHAFT OF A REAMER HANDLE BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25136347 ↗
• MalfunctionApr 3, 2026Break

  IT WAS REPORTED THAT, DURING A THA, AN REAMER HANDLE SNAPPED AT THE ADAPTOR/HANDLE JUNCTION. NO PIECES WERE LOST. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24776555 ↗
• MalfunctionMar 30, 2026Break

  IT WAS REPORTED THAT DURING A THR SURGERY, THE REAMER HANDLE BROKE UPON REAMING. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24724910 ↗
• MalfunctionMar 18, 2026Break

  IT WAS REPORTED THAT, DURING A THA SURGERY, THE TIP OF THE REAMER HANDLE WAS BROKEN WHILE REAMING SOCKET. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24626494 ↗
• MalfunctionFeb 8, 2026Break; Fracture; Material Deformation

  IT WAS REPORTED THAT DURING A THR SURGERY ONE (1) REAMER HANDLE BROKE UPON IMPACTION. THE PROCEDURE WAS COMPLETED, AFTER NO DELAY, WITH A SIMILAR S+N BACK UP PRODUCT. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24288434 ↗
• MalfunctionJan 15, 2026Break

  IT WAS REPORTED THAT, DURING A THA SURGERY, EIGHT REAMER HANDLE ARE BROKEN DUE TO USE OVER TIME. IT IS UNKNOWN THE SECTION ON THE DEVICE FOR THE REPORTED DAMAGE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24086677 ↗
• MalfunctionDec 1, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR THE CONNECTION PIECE AT THE END OF A REAMER HANDLE BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23685507 ↗
• MalfunctionNov 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A THA SURGERY, ONE (1) REAMER HANDLE WAS BENT AND ANOTHER (1) REAMER HANDLE WAS MISSING THE LOCKING COLLAR. IT IS UNKNOWN HOW PROCEDURE WAS COMPLETED OR IF THIS CAUSED ANY DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23565745 ↗
• MalfunctionSep 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A THR SURGERY, IT WAS NOTICED THAT THE REAMER HEAD FASTENER OF ONE (1) REAMER HANDLE CAME APART DURING REAMING. ALL PARTS WERE RECOVERED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY USING A S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23130268 ↗
• MalfunctionJul 21, 2025Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT, DURING THR SURGERY, ONE (1) REAMER HANDLE WAS BROKEN. IT BROKE AT THE END THAT GOES INTO THE POWER ADAPTER/CHUCK. NOTHING FELL INTO THE PATIENT. 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 22560617 ↗
• MalfunctionJul 2, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A BIRMINGHAM HIP RESURFACING SURGERY, ONE (1) REAMER HANDLE BROKE NEAR THE CONNECTION POINT TO THE REAMER DOME AND COULD NO LONGER BE ATTACHED TO IT. 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 22391623 ↗
• MalfunctionMay 9, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT, DURING THR, ONE (1) REAMER HANDLE BROKE. 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 21996790 ↗
• MalfunctionMar 25, 2025Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE CONNECTING PIECE OF ONE (1) REAMER HANDLE BROKE. THE PROCEDURE WAS RESUMED WITHOUT DELAY USING A SMITH AND NEPHEW BACKUP DEVICE, AND NO INJURIES WERE REPORTED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21693866 ↗
• MalfunctionSep 26, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT, DURING A THR, THE REAMER HANDLE WAS ROTATING OUTSIDE OF ITS ORIGINAL AXIS. THE INTENDED ACETABULAR DIAMETER WAS DAMAGED A LITTLE BEYOND THE DIAMETER DESCRIBED ON THE REAMER DOME. THE PLAN WAS GRADUALLY ADJUSTED AS THEY INCREASED THE DIAMETER OF THE REAMERS (CHANGING TO THE LARGER REAMER), WITHOUT AFFECTING THE PATIENT. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Laceration(s)

  MAUDE report 20316070 ↗
• MalfunctionJun 23, 2024Fracture; Fracture

  IT WAS REPORTED THAT, WHILE REAMING IN A THR SURGERY, THE PROXIMAL END TO THE DRILL OF ONE (1) REAMER HANDLE BROKE OFF. IT BROKE INTO TWO PIECES OF WHICH NONE GOT INSIDE THE PATIENT. 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 19591843 ↗
• MalfunctionJan 15, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR SURGERY, THE SHAFT OF A REAMER HANDLE BROKE NEAR THE QUICK CONNECT INSERTION END. IT HAPPENED WHILE THE CUP WAS BEING REAMED, SO THE REAMER AND REAMER SHAFT CONNECTOR WERE IN THE PATIENT AND THE END CONNECTED TO THE DRILL WERE OUT OF THE PATIENT. 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 18511174 ↗
• MalfunctionDec 27, 2023Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING SURGERY, TWO (1) REAMER HANDLE WAS NOTICED TO BE BENT THROUGH REGULAR USE OF PRODUCT. REPLACEMENT REQUESTED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM. AS PER INVESTIGATION RESULTS, IT WAS FOUND THAT THE TIP OF THE REAMER HANDLE DEVICE IS FRACTURED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18398490 ↗
• MalfunctionDec 26, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, A REAMER HANDLE BROKE WHILE REAMING. NO PIECES WERE LEFT BEHIND, ALL WERE MANUALLY 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 18392438 ↗
• MalfunctionNov 27, 2023Fracture; Material Deformation; Fracture; Material Deformation

  IT WAS REPORTED THAT, DURING THR SURGERY, A REAMER HANDLE BROKE WHILE USING THE INSTRUMENT IN THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY GREATER THAN 30 MIN, WITH THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18212752 ↗
• MalfunctionOct 17, 2023Break; Break

  IT WAS REPORTED THAT, DURING THR SURGERY, ONE (1) REAMER HANDLE BROKE WHERE IT MEETS DRILL ATTACHMENT. 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 17954460 ↗
• MalfunctionSep 25, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE TIP OF A REAMER HANDLE BROKE OFF, WHEN REMOVING IT FROM THE DRILL. NO PIECES FELL INSIDE THE PATIENT. 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 17810200 ↗
• MalfunctionAug 15, 2023Break; Break

  IT WAS REPORTED THAT DURING THR SURGERY, ONE (X1) REAMER HANDLE BROKE WHILE REAMING THE ACETABULUM, NO PIECES OF THE BROKEN INSTRUMENT WERE LEFT IN THE PATIENT. 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 17553558 ↗
• MalfunctionMar 21, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TOTAL RIGHT HIP REPLACEMENT, WHILE PROCEEDING TO PERFORM THE ACETABULAR REAMING, THE HANDLE OF THE REAMER HANDLE SPLIT WHERE IT ATTACHES TO THE ENGINE. THE DEVICE BROKE INSIDE THE PATIENT, BUT THE PARTS WERE RECOVERED. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. THE PATIENT'S HEALTH CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16587723 ↗
• MalfunctionDec 9, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, IN THE ACT OF REAMING THE ACETABULUM, THE METAL STEM FROM THE REAMER HANDLE BROKE IN THE HUDSON ADAPTER OF THE POWER TOOL. THE ITEM WAS REMOVED FROM THE FIELD. NOTHING FELL INTO THE WOUND AND ALL PARTS WERE RECOVERED AFTER THE PROCEDURE. 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 15948840 ↗

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