SYNERGY 71366414Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03596010199904), received between Feb 21, 2021 and Mar 17, 2022 — classified as 9 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2022Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE MAGNET OF A SYN TRIAL NECK SZ 14-18 BROKE OFF WHILE SURGEON WAS USING IT. SURGERY WAS FINISHED WITHOUT ANY DELAY, 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 13792029 ↗
• MalfunctionFeb 28, 2022Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT, THE MAGNET OF A SYN TRIAL NECK SZ 14-18 APPEARS TO BE PEELING AWAY. 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 13624796 ↗
• MalfunctionFeb 28, 2022Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT, THE MAGNET A SYN TRIAL NECK SZ 14-18 APPEARS TO BE PEELING AWAY. 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 13624781 ↗
• MalfunctionMay 21, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR, A SYN TRIAL NECK SZ 14-18 BROKE. DEVICE 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 11864072 ↗
• MalfunctionMar 8, 2021Break; Corroded; Break; Corroded

  IT WAS REPORTED THAT DURING SERVICE/PM, MAGNET ON THE SYNERGY TRIAL NECK SIZE 14-18 WAS FOUND TO BE CHIPPED AND CORRODED. THERE WAS NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11431130 ↗
• MalfunctionFeb 28, 2021Break; Corroded; Break; Corroded

  IT WAS REPORTED THAT THE MAGNETS ON THE DEVICE ARE CORRODED/CHIPPED. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11390968 ↗
• MalfunctionFeb 26, 2021Break; Corroded; Break; Corroded

  IT WAS REPORTED THAT, THE MAGNETS OF THE SYN HO TRIAL NECK SZ 14-18 ARE CORRODED, CHIPPED, AND FALLING OUT. INCIDENT OCCURRED DURING SERVICE; THEREFORE, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11386084 ↗
• MalfunctionFeb 25, 2021Break; Corroded; Break; Corroded

  IT WAS REPORTED THAT, DURING PREVENTIVE MAINTENANCE SERVICE, THE MAGNETS OF TWO SYNERGY TRIAL NECK SIZE 8-13 WERE FOUND CHIPPED/CORRODED/FALLING OUT. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11376948 ↗
• MalfunctionFeb 21, 2021Corroded; Fracture; Corroded; Fracture

  IT WAS REPORTED THAT THE MAGNETS ON THE SYNERGY TRIAL ARE CORRODED/FALLING OUT. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11356765 ↗

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