REDAPT 71355094Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 00885556223093), received between Sep 25, 2019 and Sep 30, 2024 — classified as 2 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionSep 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A HIP CONVERSION CASE OF A PRIMARY TFNA ORIF SYSTEM TO A REDAPT THA, TWO (2) REDAPT REAMERS QUICK CONNECT DETACHED WHILE REAMING THE FEMORAL CANAL. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY GREATER THAN 30 MINUTES, WITH THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20334097 ↗
• MalfunctionNov 12, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR, WHILE EXTRACTING THE REAMER, THE CONNECTION OF A REDAPT REAMER QUICK CONNECT BROKE. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A BACK-UP DEVICE. THE PATIENT WAS NOT INJURED AS A CONSEQUENCE OF THIS PROBLEM. INVESTIGATION FOUND THAT INNER PART OF THE CONNECTION OF THE DEVICE THAT ATTACHES TO THE REAMER, FRACTURE. WHICH MAKES IT A REPORTABLE EVENT. 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 15785864 ↗
• MalfunctionMay 20, 2022Break; Break

  IT WAS REPORTED THAT, THE REDAPT REAMER QUICK CONNECT WAS BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14462574 ↗
• MalfunctionMay 4, 2022Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE SLIDE MECHANISM FOR RELEASE OF THE REDAPT REAMER QUICK CONNECT DOES NOT ARTICULAR FULLY. AS THIS WAS NOTICED UPON FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14283774 ↗
• MalfunctionMay 14, 2021Fitting Problem; Physical Resistance/Sticking; Fitting Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING SET UP FOR THR SURGERY, THE REDAPT REAMER QUICK CONNECT WILL NOT RETRACT TO ACCEPT REAMER. A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE. NO INJURY TO PATIENT OR DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11828304 ↗
• InjuryMay 12, 2021Break; Break

  IT WAS REPORTED THAT DURING A THR, THE REDAPT REAMER QUICK CONNECT BROKE INSIDE 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 11814360 ↗
• MalfunctionMay 11, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING THR SURGERY, TWO REDAPT REAMER QUICK CONNECT GOT STUCK AND ARE NO WORKING PROPERLY. A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO INJURY OR DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11810111 ↗
• MalfunctionMay 11, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING THR SURGERY, TWO REDAPT REAMER QUICK CONNECT GOT STUCK AND ARE NO WORKING PROPERLY. A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO INJURY OR DELAY 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 11809767 ↗
• MalfunctionMay 10, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT DURING SET UP FOR THR, THE READAPT REAMER QUICK CONNECT DID NOT ENGAGE WITH THE REAMER, SINCE IT WAS JAMMED. NO SURGICAL DELAY WAS REPORTED. THE PROCEDURE WAS FINISHED USING AN SMITH AND NEPHEW BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11803034 ↗
• MalfunctionApr 23, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING A THR, THE DISTAL REAMER OF A REDAPT REAMER QUICK CONNECT WOULD NOT CONNECT TO THE QUICK CONNECT. NO PATIENT INJURY WAS REPORTED. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11716020 ↗
• MalfunctionApr 23, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING A THR, THE DISTAL REAMER OF A REDAPT REAMER QUICK CONNECT WOULD NOT CONNECT TO THE QUICK CONNECT. THERE WAS NO SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING A SMITH & NEPHEW BACK UP. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11716009 ↗
• MalfunctionDec 30, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT BEFORE SURGERY, THE REDAPT REAMER QUICK CONNECT WAS NOTICED TO BE CONTAMINATED WITH BLOOD. BACKUP DEVICE FROM SMITH AND NEPHEW WAS AVAILABLE AND NO DELAY OR INJURY OCCURRED DUE TO THIS EVENT. 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 11097570 ↗
• MalfunctionDec 30, 2020Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT BEFORE SURGERY, THE REDAPT REAMER QUICK CONNECT WAS NOTICED TO BE CONTAMINATED WITH BLOOD. BACKUP DEVICE FROM SMITH AND NEPHEW WAS AVAILABLE AND NO DELAY OR INJURY OCCURRED DUE TO THIS EVENT. 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 11097560 ↗
• MalfunctionDec 30, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, THE REDAPT REAMER QUICK CONNECT ADAPTERS DO NOT FUNCTION PROPERLY AND WON'T CAPTURE THE REAMER CORRECTLY IN ORDER FOR USE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. 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 11097428 ↗
• MalfunctionDec 30, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, THE REDAPT REAMER QUICK CONNECT ADAPTERS DO NOT FUNCTION PROPERLY AND WON'T CAPTURE THE REAMER CORRECTLY IN ORDER FOR USE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. 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 11097407 ↗
• MalfunctionDec 3, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE REDAPT REAMER QUICK CONNECT IS STARTING TO STICK AND NOT MOVE SMOOTHLY. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10938863 ↗
• MalfunctionDec 3, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE REDAPT REAMER QUICK CONNECT IS STARTING TO STICK AND NOT MOVE SMOOTHLY. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10938838 ↗
• MalfunctionNov 26, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE REDAPT REAMER QUICK CONNECTORS WAS FOUND WITH STICKING ISSUES. THIS IS CAUSING A HARD TIME ADDING AND REMOVING REAMERS TO QUICK CONNECT HANDLES. NO CASE ISSUES REPORTED, THEREFORE NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10912582 ↗
• MalfunctionNov 26, 2020Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE REDAPT REAMER QUICK CONNECTORS WAS FOUND WITH STICKING ISSUES. THIS IS CAUSING A HARD TIME ADDING AND REMOVING REAMERS TO QUICK CONNECT HANDLES. NO CASE ISSUES REPORTED, THEREFORE NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10912580 ↗
• InjurySep 9, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT DURING SURGERY WHILE REAMING THE FEMORAL CANAL WITH THE REDAPT REAMER QUICK CONNECT IT WAS DIFFICULT TO DISENGAGE IT FROM THE REAMER. SURGEON USED A HAMMER TO TAP THE SLEEVE OF THE QUICK CONNECT TO DISENGAGE THE DEVICES. THE OUTER SLEEVE WAS COMPLETELY SEIZED AND WOULD NOT TRANSLATE BACK AND FORTH. A DELAY OF LESS THAN 30 MIN WAS REPORTED. S & N BACK UP 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: Failure of Implant; No Known Impact Or Consequence To Patient

  MAUDE report 10511481 ↗
• MalfunctionJan 21, 2020Data Back-Up Problem; Data Back-Up Problem

  IT WAS REPORTED THAT WHEN SETTING UP FOR THE CASE WHEN CONNECTING THE REAMER QUICK-CONNECT HANDLE TO THE DISTAL REAMER IT WAS DIFFICULT PULLING BACK THE SHAFT OF THE QUICK CONNECT HANDLE. NURSE WAS DIRECTED TO TRY THE SECOND HANDLE AND FOUND THE SAME ISSUE. HE WAS THEN TOLD TO GENTLY TAP THE HANDLE ON THE EDGE OF THE TRAY TO HELP LOOSEN THE SHAFT AND LARGE SHARDS OF DRIED BLOOD FELL FROM BOTH HANDLES INTO THE TRAY OF REAMERS. THAT TRAY WAS DEEMED UNSTERILE AND AS THERE ARE NO ALTERNATIVES TO THE REAMER QUICK CONNECT HANDLES THE SURGEON HAD NO OTHER OPTION BUT TO USE A COMPETITOR SYSTEM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9610398 ↗
• MalfunctionJan 13, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT BEFORE SURGERY, WHILE SETTING UP FOR THE CASE, IT WAS DIFFICULT TO CONNECT THE REAMER QUICK CONNECT HANDLE TO THE DISTAL REAMER, A SECOND HANDLE (BACK UP) WAS USED BUT THE SAME ISSUE WAS FOUND WITH THIS INSTRUMENT. AFTER A GENTLE TAP OF THE HANDLES ON THE EDGE OF THE TRAY TO HELP LOOSEN THE SHAFT, LARGE SHARDS OF DRIED BLOOD FELL FROM THE DEVICE INTO THE TRAY OF REAMERS (TRAY WAS DEEMED UNSTERILE). A COMPETITOR¿S DEVICE WAS USED TO COMPLETE THE SURGERY, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9580283 ↗
• MalfunctionJan 13, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT BEFORE SURGERY, WHILE SETTING UP FOR THE CASE, IT WAS DIFFICULT TO CONNECT THE REAMER QUICK CONNECT HANDLE TO THE DISTAL REAMER, A SECOND HANDLE (BACK UP) WAS USED BUT THE SAME ISSUE WAS FOUND WITH THIS INSTRUMENT. AFTER A GENTLE TAP OF THE HANDLES ON THE EDGE OF THE TRAY TO HELP LOOSEN THE SHAFT, LARGE SHARDS OF DRIED BLOOD FELL FROM THE DEVICE INTO THE TRAY OF REAMERS (TRAY WAS DEEMED UNSTERILE). A COMPETITOR¿S DEVICE WAS USED TO COMPLETE THE SURGERY, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9580267 ↗
• MalfunctionSep 27, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT EVEN AFTER MULTIPLE CLEANING BY THE SPD STAFF STILL CONTAIN BIO-BURDEN. THE INSTRUMENTS APPEAR TO BE CLEAN, BUT AFTER WORKING THE SPRING MECHANISM UP AND DOWN, IT REVEALS DEBRIS. A DELAY GREATER THAN 30 MIN WAS REPORTED. NO BACKUP DEVICE WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9130399 ↗
• MalfunctionSep 25, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT EVEN AFTER MULTIPLE CLEANING BY THE SPD STAFF STILL CONTAIN BIO-BURDEN. THE INSTRUMENTS APPEAR TO BE CLEAN, BUT AFTER WORKING THE SPRING MECHANISM UP AND DOWN IT REVEALS DEBRIS. A DELAY GREATER THAN 30 MIN WAS REPORTED. NO BACKUP DEVICE NOT AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9119342 ↗

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