NA 03.111.013Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886982072122), received between Feb 25, 2019 and Jul 23, 2025 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (7 reports).

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 23, 2025Break; Break

  IT WAS REPORTED THAT ON JULY 6, 2025, THE BLUE HANDLE IN SYNTHES JOINT PREP SET WAS DROPPED AND BROKE. THERE WERE NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22577463 ↗
• MalfunctionApr 10, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE HANDLE DOES NOT WORK ANYMORE; INSTRUMENTS CANNOT BE LOCKED ANYMORE TO THE COUPLING. EVENT DID NOT HAPPEN DURING SURGERY. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21814573 ↗
• MalfunctionJan 30, 2025Break; Break

  IT WAS REPORTED THAT THE LOCKING MECHANISM ON THE HANDLE WAS BROKEN OFF. IT IS UNKNOWN WHEN THE BREAKAGE OCCURRED. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21273000 ↗
• MalfunctionApr 29, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT 03.111.013 _3L78331 WAS BROKEN. THIS REPORT IS FOR ONE (1) HANDLE SHORT W/QUICK-COUPL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14253682 ↗
• MalfunctionFeb 17, 2021Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT THE INSTRUMENT BROKE. PROCEDURE AND PATIENT INVOLVEMENT ARE UNKNOWN. THIS REPORT INVOLVES ONE SILICONE HANDLE QUICK COUPLING/SHORT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11339759 ↗
• MalfunctionJan 27, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN (B)(6) 2021, THE SILICONE HANDLE QUICK COUPLING/SHORT BROKE. IT SEEMS THERE IS ONLY ONE CIRCLE OF THIN METAL CONNECTING THE 2 PARTS. THERE WAS NO PATIENT CONSEQUENCES REPORTED. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) SILICONE HANDLE QUICK COUPLING/SHORT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11240437 ↗
• MalfunctionSep 1, 2020Device-Device Incompatibility; Device-Device Incompatibility

  UPDATED EVENT: THE DEVICE MALFUNCTION WAS FOUND DURING INSPECTION. NO PATIENT OR PROCEDURE INVOLVEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10479735 ↗
• MalfunctionOct 31, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE SILICONE HANDLE WAS BROKEN. CAUSE WAS UNKNOWN. THERE ARE NO SURGICAL PROCEDURE OR PATIENT INVOLVEMENT. THIS REPORT IS FOR 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9261551 ↗
• MalfunctionAug 13, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2019 THE HANDLE BROKE INTO TWO PARTS WHEN USING WITH THE CHISEL. ALTERNATE INSTRUMENT WAS USED AFTER THAT. NO PATIENT STATUS REPORTED. CONCOMITANT DEVICE REPORTED: UNKNOWN CHISEL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) SILICONE HANDLE QUICK COUPLING/SHORT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8887912 ↗
• MalfunctionFeb 25, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN ORTHOPEDIC PROCEDURE, THE SHAFT FOR TREPHINE ATTACHMENTS AND SHORT SILICONE HANDLE QUICK COUPLING WERE LODGED TOGETHER AFTER APPROPRIATE USE TO OBTAIN BONE GRAFT. THE SURGEON TRIED TO DISLODGED THE TWO INSTRUMENTS, HOWEVER, THEY BECAME LODGED IN ONE ANOTHER AND ARE NO LONGER FUNCTIONAL. THERE WERE NO FRAGMENTS GENERATED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) SHORT SILICONE HANDLE QUICK COUPLING. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8367540 ↗