NA 7205310Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03596010251381), received between Jun 1, 2018 and Dec 22, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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. How this data works · Data updated Oct 13, 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.

• MalfunctionDec 22, 2025Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A MENISCUS JOINT CLEANING PROCEDURE, IT WAS NOTICED THAT THE TEETH ON THE INNER CORE OF THE SYNOVATOR BLADE 4.5 WERE MISSING SO THE BLADE COULDN'T MOVE ANYMORE. THE PROCEDURE WAS RESUMED AFTER A NON-SIGNIFICANT SURGICAL DELAY, USING AN EQUIVALENT S+N BACK UP PRODUCT. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23871709 ↗
• MalfunctionJul 8, 2025Break; Break

  IT WAS REPORTED THAT, DURING SURGERY, THE SYNOVATOR BLADE BROKE. IT IS UNKNOWN IF THERE WAS A BACK-UP DEVICE AVAILABLE OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22447592 ↗
• MalfunctionApr 18, 2024Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING SET UP AN AIR LEAKAGE WAS FOUND IN THE STERILE PACKAGE OF THREE (3) SYNOVATOR BLADES. THERE WAS A BACK-UP DEVICE AVAILABLE AND A SURGICAL DELAY LESS THAN 30 MINUTES WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19140810 ↗
• MalfunctionNov 27, 2018Contamination /Decontamination Problem

  IT WAS REPORTED THAT DURING SURGERY, A DELAY OF MORE THAN 30 MINUTES WAS CAUSED DUE TO THE SURGEONS FOUND A METAL DEBRIS WHEN THEY WERE USING A PLANER TO CUT SOFT TISSUE. AFTER WASHING WITH SALINE, SOME METAL DEBRIS REMAINS IN THE PATIENT'S JOINT CAVITY. UNKNOWN IF BACKUP WAS AVAILABLE AND HOW THE ISSUE WAS RESOLVED, BUT NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8108168 ↗
• MalfunctionNov 8, 2018Crack

  IT WAS REPORTED THAT THE SURGEON APPLIED TO MUCH PRESSURE ON THE PRODUCT AND THE SYNOVATOR BLADE CRACKED DURING THE PROCEDURE. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8051625 ↗
• MalfunctionNov 1, 2018Material Disintegration

  IT WAS REPORTED THAT THE DEVICE WAS SHEDDING METAL DEBRIS DURING AN ANKLE ARTHROSCOPY. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8029004 ↗
• MalfunctionJun 1, 2018Material Fragmentation; Metal Shedding Debris

  IT WAS REPORTED THAT THE DEVICE WAS SHEDDING DURING PROCEDURE. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY AND NO PATIENT INJURIES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7562967 ↗