TANDEM 71362804Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 03596010497994), received between Feb 13, 2019 and Jul 30, 2024 — classified as 1 injury, 17 malfunctions.

The most frequently reported specific device problem is “Break” (16 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2024Break; Break

  IT WAS REPORTED THAT DURING A THR, THE THREADS ON A TANDEM STR THREADED HNDLE WERE BROKEN, THEREFORE THE TRIALS WON'T SCREW ON. THERE WAS NO 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 19861293 ↗
• MalfunctionSep 13, 2022Break

  IT WAS REPORTED THAT AFTER THR, THE END OF THE TANDEM STR THREADED HNDLE BROKEN OFF. NO DELAY REPORTED. A SN BACKUP DEVICE IS AVAILABLE. AS THIS HAPPENED AFTER SURGERY, THE PATIENT WAS NOT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15415217 ↗
• MalfunctionDec 13, 2021Crack; Crack

  IT WAS REPORTED THAT, DURING A THR SURGERY, A TANDEM STR THREADED HANDLE WAS CRACKED AFTER DROPPING IN THE GROUND. SURGERY WAS COMPLETED, WITHOUT ANY DELAY, USING A SN BACK-UP DEVICE. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12990890 ↗
• MalfunctionSep 19, 2021Break; Break

  IT WAS REPORTED THAT A TANDEM STRAIGHT THREADED HANDLE IS BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12493534 ↗
• MalfunctionJul 29, 2021Break; Break

  IT WAS REPORTED THAT, A TANDEM STR THREADED HNDLE BROKE WHILE BEING CLEANED DURING STERILE PROCESSING AFTER A THR SURGERY. NO PATIENT WAS HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12243756 ↗
• MalfunctionMay 20, 2021Fracture; Fracture

  IT WAS REPORTED THAT DURING SET UP FOR A HEMIARTHROPLASTY PROCEDURE, THE HANDLE OF A TANDEM TRIAL HOLDING ROD WAS BROKEN IN HALF WHEN TRAY WAS OPENED FOR THE SURGERY. 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 11853501 ↗
• MalfunctionApr 28, 2021Break; Break

  IT WAS REPORTED THAT THE TANDEM STR THREADED HANDLE SNAPPED IN HALF. AS THIS WAS NOTICED UPON FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11742465 ↗
• MalfunctionMar 11, 2021Break; Break

  IT WAS REPORTED THAT DURING A TANDEM BIPOLAR SURGERY, THE TANDEM STR THREADED HNDLE BROKE, INSTRUMENTS OUTSIDE PATIENT. PROCEDURE FINISHED WITH S&N BACKUP DEVICE. NO SURGICAL DELAY OR INJURY TO PATIENT REPORTED DUE THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11464463 ↗
• MalfunctionMar 4, 2021Break; Break

  IT WAS REPORTED THAT, DURING INSPECTION, THE HANDLE OF THE TANDEM STRAIGHT THREADED HANDLE BROKE IN TWO. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11408826 ↗
• InjuryFeb 12, 2021Break; Break

  IT WAS REPORTED THAT THE TANDEM STR THREADED HANDLE BROKE. THE SURGEON WAS TRIALING WITH A 52 HEAD AND IT BROKE IN HIS HAND. WHILE PUTTING IN THE TRIAL HEAD. NOTHING WAS LEFT IN THE PATIENT. IT IS UNKNOWN IF THERE WAS A DELAY OR HOW THE PROCEDURE WAS FINISHED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11321589 ↗
• MalfunctionNov 20, 2020Break; Break

  IT WAS REPORTED THAT DURING EFIP INSPECTION, BOTH INSTRUMENTS CRACKED AT THE HANDLES AND EASILY BROKE APART WHILE HANDLING. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10880170 ↗
• MalfunctionOct 30, 2020Break; Break

  IT WAS REPORTED THAT THE TANDEM STR THREADED HANDLE WAS FOUND IN TRAY BROKEN WHILE INSPECTING INSTRUMENTS. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10765802 ↗
• MalfunctionOct 15, 2020Break; Break

  IT WAS REPORTED THE HANDLE BROKE OFF. PATIENT INJURIES WERE NOT REPORTED. IT IS UNKNOWN WHEN THE EVENT OCCURRED, HOW THE PROCEDURE FINISHED AND IF THERE WERE A SURGICAL DELAY. 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 10687306 ↗
• MalfunctionAug 19, 2020Break; Break

  IT WAS REPORTED THAT THE HANDLE WAS FOUND BROKEN, THIS WAS DISCOVERED AFTER THE CASE. NO PATIENT WAS AFFECTED OR DELAYS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10429050 ↗
• MalfunctionNov 5, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY HANDLE BROKE DOWN THE MIDDLE ON INSERTION OF TRIAL HEADS. NO HARM TO THE PATIENT OR STAFF. NOTHING GOT INTO THE PATIENT. NO PROCEDURAL DELAY BECAUSE A SMITH AND NEPHEW BACK UP WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9280302 ↗
• MalfunctionApr 9, 2019Break; Break

  IT WAS REPORTED THAT THE POLY HANDLE ON THE TANDEM STRAIGHT THREADED HANDLE BROKE IN TWO AT THE BASE WHERE THE METAL STRAIGHT STEM ENDS. PICTURES OF THE INSTRUMENT ARE AVAILABLE. THE PROCEDURE WAS COMPLETED WITH NO DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8497221 ↗
• MalfunctionMar 20, 2019Break; Break

  IT WAS REPORTED THAT THE TANDEM BIPOLAR STRAIGHT HANDLE BROKE WHILE DR. (B)(6) WAS IMPACTING THE TRAIL HEAD. I WOULD LIKE A REPLACEMENT. NO INJURIES OR DELAYS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8436707 ↗
• MalfunctionFeb 13, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE PLASTIC HANDLE ON IMPACTOR BROKE DURING TRIALING USAGE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING AN S&N BACK-UP DEVICE. ALL PIECES WERE RECOVERED AND THE PATIENT WAS NOT AFFECTED. THE FINAL OUTCOME OF THE SURGERY WAS AS PLANNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8337978 ↗

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