SYNERGY 71366408Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 03596010199898), received between Feb 21, 2021 and Dec 29, 2025 — classified as 16 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 29, 2025Break; Break

  IT WAS REPORTED THAT DURING A HEMI THR SURGERY, ONE (1) SYN TRIAL NECK SZ 8-13 BROKE. THE PROCEDURE RESUMED WITHOUT ANY DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23906217 ↗
• MalfunctionMar 17, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING THR SURGERY, THE MAGNET OF THE SYN TRIAL NECK SZ 8-13 WAS FALLING APART. 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 13792129 ↗
• MalfunctionFeb 28, 2022Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT, THE MAGNETS OF A SYN TRIAL NECK SZ 8-13 APPEAR 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 13624972 ↗
• MalfunctionFeb 28, 2022Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT, THE MAGNETS OF A SYN TRIAL NECK SZ 8-13 APPEAR 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 13624964 ↗
• MalfunctionFeb 28, 2022Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT, THE MAGNETS OF A SYN TRIAL NECK SZ 8-13 APPEAR 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 13624936 ↗
• MalfunctionFeb 28, 2022Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT, THE MAGNET OF A SYN TRIAL NECK SZ 8-13 APPEARS TO BE PEELING AWAY. AS THIS WAS NOTICED IN A NO-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13624862 ↗
• MalfunctionFeb 28, 2022Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT, THE MAGNET OF A SYN TRIAL NECK SZ 8-13 APPEARS TO BE PEELING AWAY. AS THIS WAS NOTICED IN A NO-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13624855 ↗
• MalfunctionFeb 28, 2022Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT, THE MAGNET OF A SYN TRIAL NECK SZ 8-13 APPEARS TO BE PEELING AWAY. AS THIS WAS NOTICED IN A NO-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13624813 ↗
• 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 11390967 ↗
• MalfunctionFeb 26, 2021Break; Corroded; Break; Corroded

  IT WAS REPORTED THAT, THE MAGNETS OF THE SYN TRIAL NECK SZ 8-13 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 11386104 ↗
• MalfunctionFeb 25, 2021Break; Corroded; Break; Corroded

  IT WAS REPORTED THAT, THE MAGNETS OF A SYNERGY TRIAL NECK SIZE 8-13 ARE CORRODED/CHIPPING. INCIDENT OCCURRED DURING LAB/DEMO; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11376961 ↗
• MalfunctionFeb 25, 2021Break; Corroded; Break; Corroded

  IT WAS REPORTED THAT, MAGNET FROM SYNERGY TRIAL NECK SIZE 8-13 IS CORRODED/CHIPPED/FALLING OUT. INCIDENT OCCURED DURING SERVICE/PM; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11376960 ↗
• MalfunctionFeb 25, 2021Break; Corroded; Break; Corroded

  IT WAS REPORTED THAT, THE MAGNETS OF A SYN TRIAL NECK SZ 8-13 ((B)(4)) AND A SYN HO TRIAL NECK SZ 14-18 ((B)(4)) ARE CORRODED/CHIPPED/FALLING OUT. INCIDENT OCCURRED DURING SERVICE; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11376958 ↗
• 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 11376949 ↗
• MalfunctionFeb 25, 2021Break; Corroded; Break; Corroded

  IT WAS REPORTED THAT, THE MAGNETS FROM THE SYN TRIAL NECK SZ 8-13 AND THE SYN HO TRIAL NECK SZ 14-18 ARE CORRODED/CHIPPED/FALLING OUT. INCIDENT OCCURRED DURING SERVICE/PM; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11376947 ↗
• 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 11356768 ↗

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