REFLECTION 71362297Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 03596010456540), received between Jan 31, 2019 and Oct 15, 2025 — classified as 4 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Break” (15 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.

• MalfunctionOct 15, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING THR SURGERY, THE REF TRIAL SHELL HANDLE HAD A BROKEN THREAD. THE IMPACTING HEAD WAS ON THE IMPACTOR HANDLE, SO THE BROKEN THREAD WAS NOT NOTICED UNTIL THE SCRUB UNSCREWED THE IMPACTING HEAD. NO, BROKEN PIECES FELL INTO THE WOUND. NO BROKEN PIECE OF THE THREAD FULLY SEPARATED FROM THE IMPACTOR HANDLE. THE PROCEDURE WAS RESUMED, AFTER 2 MINUTES DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23301364 ↗
• MalfunctionJul 25, 2023Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE THREADS ON A REF TRIAL SHELL HANDLE BROKE DURING USE. 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 17393213 ↗
• MalfunctionFeb 20, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, WHEN THE SURGEON TRIED TO REMOVE A TRIAL SHELL HE WAS UNABLE TO DO SO, WHEN HE TWISTED THE REF TRIAL SHELL HANDLE, THE THREAD CAME APART FROM THE HANDLE. 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 16406346 ↗
• MalfunctionMay 6, 2022Fracture; Deformation Due to Compressive Stress; Fracture; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT, DURING THR SURGERY, THE TIP OF A REF TRIAL SHELL HANDLE BECAME CROSS THREADED AND BROKE OFF (OUTSIDE THE PATIENT). NO SURGICAL DELAY WAS REPORTED TO OCCUR, AND THE PROCEDURE WAS COMPLETED WITH A SMITH AND NEPHEW BACK UP DEVICE. NO PATIENT HARM WAS REPORTED TO OCCUR DUE TO THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14307191 ↗
• MalfunctionMar 29, 2022Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE THREADED TIP OF A REF TRIAL SHELL HANDLE BROKE OFF AS THE SCRUBBED NURSE WENT TO UNTHREAD IT FROM THE TRIAL CUP. IT HAPPENED OUTSIDE OF THE PATIENT, SO NO HARM WAS DONE TO THE PATIENT. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A S+N BACK UP DEVICE. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13945748 ↗
• MalfunctionJan 4, 2022Break; Break

  IT WAS REPORTED THAT, DURING THE SET UP FOR A THR SURGERY, A REFLECTION TRIAL SHELL HANDLE WAS DISCOVERED TO BE BROKEN. SURGERY WAS PERFORMED, WITH A BACK-UP DEVICE INSTEAD. IT IS UNKNOWN IF THIS CAUSED ANY DELAY. SINCE INCIDENT OCCURRED BEFORE PROCEDURE, PATIENT WAS NOT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13160200 ↗
• InjuryNov 9, 2021Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT, DURING TOTAL HIP REPLACEMENT, A REFLECTION TRIAL SHELL HANDLE BROKE WHEN SURGEON WAS TRYING TO TIGHTEN TRIAL HEAD. THREADS OF THE DEVICE BECAME STRIPPED. THIS OCCURRED INSIDE THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH & NEPHEW BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12779400 ↗
• MalfunctionSep 21, 2021Break; Break

  IT WAS REPORTED THAT, DURING THR SURGERY, A REF TRIAL SHELL HANDLE WAS BROKEN. SURGERY WAS RESUMED, WITHOUT ANY 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 12511056 ↗
• MalfunctionMay 11, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING SET UP AND INSPECTION, IN A THR , THE REF TRIAL SHELL HANDLE, WAS FOUND WORN AND TORN; HENCE, NEED TO BE REPLACED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING THE SAME DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11807234 ↗
• MalfunctionApr 20, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE REFLECTION TRIAL SHELL HANDLE IS STRIPPED. SINCE IT WAS NOTICED DURING A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11693239 ↗
• InjuryApr 12, 2021Break; Connection Problem; Break; Connection Problem

  IT WAS REPORTED THAT, WHILE IMPACTING THE TRIAL CUP IN, ONE OF THE THREADS BROKE LOOSE. THIS CAUSED THE IMPACTOR TO NOT GRAB THE TRIAL CUP WELL. THE IMPACTOR WAS DISCONTINUED AND A SN BACK UP WAS USED IN ORDER TO COMPLETE THE PROCEDURE. NO PIECES FELL INTO THE PATIENT. ALL PIECES WERE RECOVERED AND THE BROKEN PIECE WAS DISCARDED. NO SURGICAL DELAY OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11648441 ↗
• MalfunctionMar 15, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE THREADS DAMAGED ON THE TIP OF IMPACTOR, SO BUMPERS WILL NOT SCREW ON. THE PROCEDURE WAS COMPLETED USING A SN BACKUP DEVICE. NO INJURY TO THE PATIENT WAS REPORTED. A DELAY OF 30 MIN OR LESS WAS REPORTED. 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 11479205 ↗
• MalfunctionFeb 2, 2021Break; Break

  IT WAS REPORTED THAT, DURING SET UP OR INSPECTION, THE NURSE STAFF CROSS THREADED THE HANDLE INTO THE TRIAL SHELL, BREAKING BOTH DEVICES. S+N BACK UP DEVICES WERE USED IN ORDER TO COMPLETE THE PROCEDURE. NO SURGICAL DELAY OR INJURY TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11270610 ↗
• MalfunctionJan 30, 2021Break; Break

  IT WAS REPORTED THAT, DURING SET UP, THE NURSING STAFF CROSS THREADED THE HANDLE INTO THE TRIAL SHELL AND BROKE BOTH INSTRUMENTS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A SMITH+NEPHEW BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11256321 ↗
• MalfunctionDec 24, 2020Break; Break

  IT WAS REPORTED THAT THE DEVICE WAS FOUND TO BE BROKEN DURING INSPECTION. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11072083 ↗
• MalfunctionDec 17, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED AFTER A THR PROCEDURE, THE STERILIZATION SERVICES DEPARTMENT (SSD) DISCOVERED THAT THE SCREW THREAD OF THE HANDLE HAD SHEARED. THE PROCEDURE THAT WAS PERFORMED PREVIOUSLY WAS COMPLETED WITHOUT DELAY, USING THE SAME DEVICE, AND NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11033161 ↗
• MalfunctionDec 15, 2020Break; Break

  IT WAS REPORTED THAT, PRIOR A THR PROCEDURE, THE THREADS ON THE REFLECTION TRIAL SHELL HANDLE WERE BROKEN. INCIDENT OCCURRED BEFORE THE PROCEDURE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. PROCEDURE WAS DONE WITH A SMITH-NEPHEW BACK-UP DEVICE. 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 11009271 ↗
• MalfunctionNov 13, 2020Break; Break

  IT WAS REPORTED THAT THE THREADS BROKE OFF INTO SHELL, THE EVENT OCCURRED OUTSIDE THE PATIENT, WHILE TRYING TO REMOVE SHELL FROM IMPACTOR. NO SURGICAL DELAY. PATIENT INJURIES WERE NOT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10837618 ↗
• MalfunctionOct 19, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING INSPECTION IT WAS FOUND THAT THE REFLECTION TRIAL SHELL HANDLE HAS THE THREADS STRIPPED. NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10696754 ↗
• MalfunctionOct 1, 2020Break; Break

  IT WAS REPORTED THAT DURING INSPECTION PROCESS WAS NOTICED THAT THE THREADS OF THE REFLECTION TRIAL SHELL HANDLE ARE BROKEN. THERE WAS NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10612531 ↗
• InjuryAug 26, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE REFLECTION TRIAL SHELL HANDLE TEARS OFF THE THREAD WHEN THE TRIAL CUP WAS INSERTED, FURTHERMORE A METAL RING OF THE BROKEN THREAD WAS FOUND IN THE PATIENT OPERATING FIELD AND WAS COMPLETELY REMOVED UNDER BV; IN ADDITION, AFTER THE THREAD WAS TORN OFF, THE METALLIC SHARPLY BROKEN OFF PARTIAL THREAD STUCK OUT OF THE TEST CUP, TEARING THE GLOVES OF THE SURGEON AND THE OPERATING NURSE; THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING THE SAME DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10457862 ↗
• MalfunctionAug 25, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE IMPACTOR HANDLE WOULD NOT THREAD INTO THE R3 CUP DUE TO THE THREADS BEING BENT. THIS OCCURRED DURING SURGERY, AN S&N BACKUP WAS AVAILABLE. SURGERY WAS NOT DELAYED. THE PATIENT WAS NOT HARMED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10449883 ↗
• InjuryAug 20, 2020Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE REFLECTION TRIAL SHELL HANDLE WAS FOUND WORN OUT: THREADS ARE STRIPPED. THE PROCEDURE WAS COMPLETED, WITHOUT ANY DELAY, BY USING A DEVICE FROM J&J. THE ALLEGED MALFUNCTION DID NOT HAVE ANY FURTHER IMPACT ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10431275 ↗
• MalfunctionAug 11, 2019Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT THREADS ON THE IMPACTOR ARE STRIPPED. IMPLANT IS NOT ABLE TO BE ATTACHED TO THE IMPACTOR. DELAY OVER 30 MINUTES WAS REPORTED. DEVICE BACKUP WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8881974 ↗
• MalfunctionMar 25, 2019Break; Break

  IT WAS REPORTED THAT THE DEVICE BROKE DURING SURGERY. THE PROCEDURE WAS COMPLETED WITHOUT DELAYS USING A BACK-UP DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8449028 ↗

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