REFLECTION 71362298Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 03596010455284), received between Mar 5, 2021 and Mar 24, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2026Break

  IT WAS REPORTED THAT, DURING A THR, ONE (1) SCREW FORCEPS 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 24674304 ↗
• MalfunctionSep 4, 2025Break; Break

  IT WAS REPORTED THAT DURING THR SURGERY, THE SCREW FORCEPS BROKE. IT IS UNKNOWN HOW WAS COMPLETED THE SURGERY OR IF A DELAY WAS PRESENTED. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22968383 ↗
• MalfunctionNov 6, 2023Break; Break

  IT WAS REPORTED THAT DURING A THR, ONE (1) SCREW FORCEPS BROKE. 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 18075752 ↗
• MalfunctionApr 16, 2023Fracture; Fracture

  IT WAS REPORTED, THAT DURING THE SURGERY, THE HANDLE OF A (1) SCREW FORCEPS BROKE. SURGERY WAS RESUMED WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO PIECES FELL INTO THE PATIENT AND NO INJURY WAS REPORTED DUE TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16748745 ↗
• MalfunctionSep 15, 2022Fracture; Fracture

  IT WAS REPORTED THAT A SCREW FORCEPS FAILED AND BROKE MID-SHAFT. IT IS UNKNOWN AT WHICH STAGE OF THE PROCEDURE WAS THIS PROBLEM NOTICED; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15434588 ↗
• MalfunctionSep 14, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING THR SURGERY, THE SCREW FORCEPS BROKE AT THE TIP AND WILL NOT HOLD THE SCREW. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A BACK-UP DEVICE INSTEAD. PATIENT WAS NOT INJURED AS A CONSEQUENCE OF THIS PROBLEM. NO PIECES FELL INTO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15422829 ↗
• MalfunctionSep 16, 2021Break; Break

  IT WAS REPORTED THAT, A SCREW FORCEPS BROKE IN HALF. IT IS UNKNOWN IF THIS HAPPENED DURING SURGERY OR NOT, THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12480557 ↗
• MalfunctionSep 9, 2021Crack; Crack

  IT WAS REPORTED THAT A SCREW FORCEP IS CRACK. IT IS UNKNOWN IN WHICH CONTEXT THIS WAS NOTICED, OR IF THERE WAS PATIENT INVOLVEMENT. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12450976 ↗
• MalfunctionAug 25, 2021Break; Break

  IT WAS REPORTED THAT REFLECTION SCREW FORCEPS WAS FOUND BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12367920 ↗
• MalfunctionJun 3, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING AN INSPECTION, IT WAS NOTICED THAT THE END OF A SCREW FORCEPS WAS BENT. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11935607 ↗
• MalfunctionMar 30, 2021Break; Break

  IT WAS REPORTED THAT, THE INSTRUMENTS BROKE DURING SURGERY. 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 11593506 ↗
• MalfunctionMar 5, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT, DURING SET UP OR INSPECTION THE SCREW FORCEPS HAVE SPRAINED. INCIDENT OCCURRED BEFORE THE PROCEDURE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11419366 ↗
• MalfunctionMar 5, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING INSPECTION PROCESS, PRIOR TO SURGERY, WAS NOTICED THAT THE SCREW FORCEPS HAVE SPRAINED. THERE WAS NO PATIENT INVOLVED WHEN THE ISSUE WAS FOUND. A SMITH AND NEPHEW BACK UP DEVICE WAS AVAILABLE TO COMPLETE THE CASE WITH ANY DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11419365 ↗

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