Accord 71360019Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010500236), received between Nov 20, 2020 and Feb 5, 2025 — classified as 7 malfunctions.

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

• MalfunctionFeb 5, 2025Break; Break

  IT WAS REPORTED THAT DURING A THR PROCEDURE, THE HANDLE OF ONE (1) ACCORD LG 30 DEG CBL OFF PSR BROKE. 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 21312886 ↗
• MalfunctionJun 19, 2022Fracture; Fracture

  IT WAS REPORTED THAT, THE ACCORD LG 30 DEG CBL OFF PSR WAS OBSERVED TO BE CRACKED. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14741297 ↗
• MalfunctionFeb 16, 2022Crack; Crack

  IT WAS REPORTED THAT, THE ACCORD LG 30 DEG CBL OFF PSR HAS DEVELOPED A CRACK IN HANDLE. THE HOSPITAL WOULD NOT STERILIZE AS IT POSES BIOHAZARD. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13543264 ↗
• MalfunctionDec 6, 2021Crack; Crack

  IT WAS REPORTED THAT, DURING SURGERY, AN ACCORD LG 30 DEG CBL OFF PSR CRACKED WHILE THE INSTRUMENT WAS OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12937180 ↗
• MalfunctionFeb 12, 2021Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE THE ACCORD LG 30 DEG CBL OFF PSR BROKE IN HALF. INSTRUMENTS OUTSIDE OF THE PATIENT. S&N BACKUP DEVICE AVAILABLE. NO SURGICAL DELAY OR INJURY TO PATIENT REPORTED DUE THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11325839 ↗
• MalfunctionDec 1, 2020Crack; Crack

  IT WAS REPORTED THAT THE ACCORD LG 30 DEGREES CBL OFF PSR WAS FOUND CRACKED. NO PROCEDURE-RELATED. THEREFORE, NO INJURIES OR SURGICAL DELAYS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10928825 ↗
• MalfunctionNov 20, 2020Break; Break

  IT WAS REPORTED THAT IN A ACCORD LG 30 DEG CBL OFF PSR, THE HANDLE BROKE WHEN THEY WERE TRYING TO PASS THE CABLE ROUND THE BONE. THEY WERE TREATING A PERIPOSTATETIC FRACTURE. THIS OCCURRED DURING USE ¿ INSTRUMENT INSIDE PATIENT. IT IS UNKNOWN HOW WAS THE PROCEDURE FINISHED. NO HARM OR INJURY REPORTED ON PATIENT. NO DELAY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10879958 ↗

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