NA 03.168.015Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982274526), received between Aug 6, 2021 and Jan 16, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2026Device-Device Incompatibility

  DURING AN FNS REMOVAL, THE SURGEON INSERTED THE MULTIFUNCTION ROD WITH THE IMPACTOR ON TOP TO GRAB BOLT AND PLATE OUT. THE THREADS OF THE MULTIFUNCTION ROD WERE OVER INSERTED IN THE BOLT AND PLATE AND WILL NOT BUDGE TO COME OUT. THERE WAS NO PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24098092 ↗
• MalfunctionNov 5, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSERTION HANDLE AND IMPACTOR BROKE. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20612377 ↗
• MalfunctionAug 6, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A REVISION SURGERY DUE TO PAIN. ORIGINALLY, THE PATIENT UNDERWENT FOR A SURGERY WITH FNS IMPLANTS ON (B)(6) 2021. ON (B)(6) 2021, THE PATIENT WAS REPORTED PAIN AND SCHEDULED FOR REVISION SURGERY. IN THE REVISION, AFTER THE ANTI-ROTATION SCREW WAS REMOVED, WHEN THE SURGEON TRIED TO REMOVE THE LOCKING SCREW WITH AN EXTRACTION SCREWDRIVER, THE SCREWDRIVER BROKE, AND THE FRAGMENT WAS REMAINED IN THE SCREW HEAD. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED. CARBIDE DRILL BIT ¿4 F/INSTR (PART# 309.004S, LOT# UNKNOWN, QUANTITY# 1), DIAMOND BAR (PART# 309.004S, LOT# UNKNOWN, QUANTITY# 1), SPARECENTERPIN F/309.065 (PART# 309.670, LOT# UNKNOWN, QUANTITY# 1), UNK - NAIL HEAD ELEMENTS: FNS BOLT (PART# UNKNOWN, LOT# UNKNOWN, QTY1), UNKNOWN UNK - NAIL HEAD ELEMENTS: FNS ANTIROTATION (PART# UNKNOWN, LOT# UNKNOWN, QTY1). THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1) CYLINDER FOR INSERTION INSTRUMENTS. THIS REPORT IS 4 OF 4 FOR (B)(4). RELATED PRODUCT COMPLAINT:

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12288963 ↗