REFLECTION 71364023Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 03596010479136), received between Sep 6, 2018 and Aug 11, 2021 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (7 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2021Break; Break

  IT WAS REPORTED THAT DURING A META TIBIAL NAIL SURGERY, TWO MI OFFSET REF IMP SD SHAFT HEADS, SNAPPED OFF. PROCEDURE WAS ABLE TO BE COMPLETED WITH A SMITH AND NEPHEW BACKUP DEVICE, A DELAY OF LESS THAN OR EQUAL TO 30 MINUTES WAS REPORTED. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12307560 ↗
• MalfunctionAug 10, 2021Break; Break

  IT WAS REPORTED THAT DURING A META TIBIAL NAIL SURGERY, TWO MI OFFSET REF IMP SD SHAFT HEADS, SNAPPED OFF. PROCEDURE WAS ABLE TO BE COMPLETED WITH A SMITH AND NEPHEW BACKUP DEVICE, A DELAY OF LESS THAN OR EQUAL TO 30 MINUTES WAS REPORTED. NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12304392 ↗
• MalfunctionJul 12, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT, DURING A THA, A MI OFFSET REFLECTION IMP SD SHAFT WAS NOTICED TO BE STRIPPED. THE PROCEDURE WAS FINISHED WITHOUT DELAY USING A SMITH & NEPHEW BACK UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12151139 ↗
• MalfunctionJul 9, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT, DURING A THA, A MI OFFSET REFLECTION IMP SD SHAFT WAS NOTICED TO BE STRIPPED. THE PROCEDURE WAS FINISHED WITHOUT DELAY USING A SMITH & NEPHEW BACK UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12143795 ↗
• MalfunctionJun 8, 2021Break; Break

  IT WAS REPORTED THAT DURING A THR SURGERY, THE MI OFFSET REFLECTION IMP SD SHAFT BROKE OUTSIDE THE PATIENT. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11963559 ↗
• MalfunctionApr 18, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING AN INSTRUMENT INSPECTION, IT WAS FOUND THAT THE THREADS ON BOTH OF THESE INSTRUMENTS WERE STRIPPED, MAKING THEM UNFIT FOR FURTHER USE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683503 ↗
• InjuryFeb 15, 2021Break; Break

  IT WAS REPORTED THAT DURING A THR THE FOLLOWING INSTRUMENTS BROKE. INSTRUMENTS INSIDE PATIENT. UNKNOWN HOW THE PROCEDURE WAS FINISHED OR IF THERE WAS A SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11326451 ↗
• MalfunctionJan 18, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING INSPECTION, WAS FOUND THAT THE MI OFFSET REFLECTION IMP SD SHAFT IS STRIPPED, IT IS NO LONGER SUITABLE FOR USE. NO CASE INVOLVED. 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 11189506 ↗
• MalfunctionNov 6, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT DURING THR PROCEDURE THE MI OFFSET REF IMP SD SHAFT GOT STRIPPED. NO DELAY AND A S&N BACK UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO INJURIES OR OTHER COMPLICATIONS WERE REPORTED AT THIS TIME. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10804642 ↗
• MalfunctionNov 6, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT AFTER THR PROCEDURE THE MI OFFSET REF IMP SD SHAFT WAS FOUND TO BE STRIPPED. NO DELAY AND PROCEDURE CONCLUDED WITH THE SAME DEVICE. NO INJURIES OR OTHER COMPLICATIONS WERE REPORTED AT THIS TIME. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10804540 ↗
• MalfunctionNov 5, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE SCREWDRIVER HAS LOST ALL THREADING AND DOESN'T WORK. IT IS UNKNOWN WHEN THE EVENT OCCURS, IF THERE WAS ANY DELAY, IF THERE WAS A BACKUP AVAILABLE TO FINISH THE PROCEDURE AND IF THERE WAS A PATIENT INVOLVED IN THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10796019 ↗
• MalfunctionNov 5, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT, DURING SURGERY, INSTRUMENT STRIPPED AND WOULD NOT WORK PROPERLY. PROCEDURE CONTINUED WITH THE SAME DEVICE WITHOUT A DELAY OR AN INJURY.

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

  MAUDE report 10794815 ↗
• MalfunctionNov 5, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT, DURING SURGERY, INSTRUMENT STRIPPED AND WOULD NOT WORK PROPERLY. PROCEDURE CONTINUED WITH THE SAME DEVICE WITHOUT A DELAY OR A INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10794601 ↗
• MalfunctionSep 28, 2020Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE DEVICE NEED REPLACING DUE TO WEAR AND TEAR. THERE WAS NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10591537 ↗
• MalfunctionSep 28, 2020Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE DEVICE NEED REPLACING DUE TO WEAR AND TEAR. THERE WAS NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10591536 ↗
• MalfunctionSep 28, 2020Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE DEVICE NEED REPLACING DUE TO WEAR AND TEAR. THERE WAS NO CASE INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10591534 ↗
• MalfunctionApr 30, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE SURGEON STATES THAT THIS DRIVER WHEN ATTACHING THE CUP IS STRIPPING. NO DELAY TO PROCEDURE, NO INJURY TO PATIENT. S&N BACKUP WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10015509 ↗
• MalfunctionSep 6, 2018Connection Problem; Connection Problem

  IT WAS REPORTED A MALFUNCTION IN WHICH THE SCREWS WERE SLIPPING ON THE DEVICE. IT WAS REQUIRED TO RETRIEVE A PLASTIC PIECE FROM THE INSIDE OUT OF PATIENT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7850921 ↗

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