REFLECTION 71362950Recalls & reported problems
Smith & Nephew, Inc. · REFLECTION FLEXIBLE DRILL 50MM · Class 2
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010463005), received between Aug 3, 2020 and Apr 26, 2025 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Material Twisted/Bent” (3 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.
Reports received per month
Most reported problems
Device problems
- Material Twisted/Bent3
- Break2
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- No Known Impact Or Consequence To Patient3
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 26, 2025Break; Break
IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) FLEXIBLE DRILL 50MM BROKE WHILE THE SURGEON WAS PERFORMING THE DRILLING. THE PIECES WERE COMPLETELY REMOVED FROM 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 21915680 ↗MalfunctionOct 9, 2024Fracture; Fracture
IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY PROCEDURE, THE TIP OF THE FLEXIBLE DRILL 50MM BROKE OFF. SURGEON WAS ABLE TO REMOVE THE PIECE. THE PROCEDURE WAS PERFORMED, AFTER NO DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20409318 ↗MalfunctionDec 13, 2021Break; Break
IT WAS REPORTED THAT, DURING THA SURGERY, A FLEXIBLE DRILL 50MM BIT SNAPPED BEFORE IT GETS TO THE DESIRE DEPTH. ALL PIECES OF THE DRILL WERE RETRIEVED. SURGERY WAS COMPLETED, AFTER A DELAY OF 30 MINUTES OR LESS, WITH A SN BACK-UP DEVICE. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12990815 ↗MalfunctionOct 28, 2020Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE DRILL BIT WAS USED IN A TOTAL HIP REPLACEMENT PROCEDURE TO DRILL A HOLE FOR REFLECTION SCREW, AFTER THREE USES THE DRILL BENT. PROCEDURE FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. PATIENT INJURIES WERE NOT REPORTED. SURGICAL DELAY LESS THAN 30 MINUTES. 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 10749579 ↗MalfunctionOct 28, 2020Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE DRILL BIT WAS USED IN A TOTAL HIP REPLACEMENT PROCEDURE TO DRILL A HOLE FOR REFLECTION SCREW, AFTER THREE USES THE DRILL BENT. PROCEDURE FINISHED WITH A SMITH AND NEPHEW BACKUP DEVICE. PATIENT INJURIES WERE NOT REPORTED. SURGICAL DELAY LESS THAN 30 MINUTES. 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 10749542 ↗MalfunctionAug 3, 2020Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT DURING A SURGERY, THE FLEXIBLE DRILL BIT BENT. A NEW S+N DEVICE HAD TO BE OPENED TO CONTINUE THE PROCEDURE WITH A DELAY OF LESS THAN 30 MINUTES. NO OTHER COMPLICATIONS WERE REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10354581 ↗
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 · TerminatedSL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
- Z-1008-2017 · Nov 16, 2016 · TerminatedREFLECTION(R) DEAD BLOW MALLET, REF 71362106, QTY: (1), NON-STERILE, Smith & Nephew, Inc,. Memphis, TN 38116
Other Prosthesis, hip, femoral component, cemented, metal devices
- GENESIS II 71440005Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal599 reports
- NA 71364073Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal436 reports
- Peri-Loc 71173377Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal401 reports
- R3 71368569Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal398 reports
- NA 71364006Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal197 reports
- NA 71364011Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal176 reports
- Accord 71360046Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal171 reports
- REFLECTION 71362279Smith & Nephew, Inc. · Prosthesis, hip, femoral component, cemented, metal155 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.