TANDEM 71362803Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 03596010481719), received between Jun 12, 2019 and Jun 11, 2026 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2026Fracture

  IT WAS REPORTED THAT, DURING A PHA SURGERY, ONE (1) TANDEM TRIAL SHELL HANDLE WAS BROKEN WHILE TRIALING THE BIPOLAR HEAD .THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A SIMILAR S+N BACK-UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25470584 ↗
• MalfunctionFeb 18, 2025Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY WHILE INSERTING THE CUP, THE HANDLE OF ONE (1) TANDEM TRIAL SHELL HANDLE BROKE IN HALF. NOTHING FELL INTO 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 21400767 ↗
• MalfunctionOct 28, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) TANDEM TRIAL SHELL HANDLE SNAPPED IN HALF DURING USE. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20552869 ↗
• MalfunctionMay 27, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY, THE TANDEM TRIAL SHELL HANDLE BROKE. NO PIECES FELL INSIDE THE WOUND. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH 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 19400795 ↗
• MalfunctionNov 25, 2021Crack; Crack

  IT WAS REPORTED THAT, DURING A THR SURGERY, A TANDEM TRIAL SHELL HANDLE CRACKED AT THE BOTTOM. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A SN BACK-UP DEVICE. NO HARM TO THE PATIENT OR ANY FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12874498 ↗
• MalfunctionDec 16, 2020Break; Break

  IT WAS REPORTED THAT THE TANDEM TRIAL SHELL HANDLE IS BROKEN. IT IS UNKNOWN HOW THIS OCCURRED. IT IS UNKNOWN WHETHER THE INCIDENT HAPPENED OR NOT IN A SURGICAL ENVIRONMENT OR IF THERE WAS A PATIENT 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 11019820 ↗
• InjuryDec 3, 2020Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, HANDLE OF THE TANDEM TRIAL SHELL HANDLE BROKE DURING IMPACTION. ALL PIECES RECOVERED. PROCEDURE CONTINUED WITH A BACKUP DEVICE FROM SMITH AND NEPHEW AND WITHOUT A DELAY. THE PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10938287 ↗
• MalfunctionNov 16, 2020Break; Break

  IT WAS REPORTED THAT DURING EFIP INSPECTION, BOTH INSTRUMENTS CRACKED AT THE HANDLES AND EASILY BROKE APART WHILE HANDLING. 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; No Known Impact Or Consequence To Patient

  MAUDE report 10848928 ↗
• MalfunctionJun 28, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY, HANDLE BROKE WHILE TAKING SLEEVE OUT OF BIPOLAR TRIAL. NOTHING FELL INTO THE PATIENT. NO HARM TO PATIENT OR STAFF. NO PROCEDURAL DELAYS BECAUSE SMITH & NEPHEW BACK UP WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8743905 ↗
• MalfunctionJun 12, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE HANDLE BROKE IN TWO. NO DELAY OR INJURY REPORTED. A BACK UP DEVICE IS NOT SPECIFIED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8693682 ↗

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