NA 395.109Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982200150), received between Dec 7, 2017 and Mar 14, 2023 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K033158, K961350, K971987); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 14, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023 INTRA-OPERATIVELY THE SUPPLY MINI-FIXATOR / JAWS AND RODS DO NOT FIT TOGETHER. THIS REPORT IS FOR ONE (1) 3.0MM CARBON FIBER ROD 60MM. THIS IS REPORT 7 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16542177 ↗
• MalfunctionMar 14, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023 INTRA-OPERATIVELY THE SUPPLY MINI-FIXATOR / JAWS AND RODS DO NOT FIT TOGETHER. THIS REPORT IS FOR ONE (1) 3.0MM CARBON FIBER ROD 60MM. THIS IS REPORT 3 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16542047 ↗
• MalfunctionJul 20, 2018Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, TEN CARBON FIBER RODS WOULD NOT FIT WITH THE CONNECTING CLAMP. SUBSTITUTE RODS WITH SAME PART NUMBERS WHERE USED INSTEAD. PROCEDURE OUTCOME AND PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR A 3.0MM CARBON FIBER ROD 60MM. THIS IS REPORT 7 OF 10 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7707498 ↗
• MalfunctionJul 20, 2018Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, TEN CARBON FIBER RODS WOULD NOT FIT WITH THE CONNECTING CLAMP. SUBSTITUTE RODS WITH SAME PART NUMBERS WHERE USED INSTEAD. PROCEDURE OUTCOME AND PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR A 3.0MM CARBON FIBER ROD 60MM. THIS IS REPORT 6 OF 10 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7707474 ↗
• MalfunctionJul 20, 2018Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, TEN CARBON FIBER RODS WOULD NOT FIT WITH THE CONNECTING CLAMP. SUBSTITUTE RODS WITH SAME PART NUMBERS WHERE USED INSTEAD. PROCEDURE OUTCOME AND PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR A 3.0MM CARBON FIBER ROD 60MM. THIS IS REPORT 5 OF 10 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7707462 ↗
• InjuryDec 7, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT SEVERAL RODS DOES NOT FIT INTO THE CLAMPS. THIS LEADS TO LOOSE FRACTURE REDUCTION STABILITY AND ALTERNATIVELY USED 2.5MM K-WIRE INSTEAD OF CARBON RODS TO HOLD THE FRACTURE. PATIENT FRACTURE WAS STABLE. THE SURGERY WAS PROLONGED TO 25 MINUTES. CONCOMITANT DEVICES: 15X 2.5MM K-WIRE, PART/LOT UNKNOWN. 13X UNK CLAMPS, PART/LOT UNKNOWN. THIS IS REPORT 2 OF 8 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7097573 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033158, K961350, K971987. One submission often covers many models, so check the product and lot details in each record.

• Z-2451-2015 · Jul 29, 2015 · Terminated
  Synthes Trauma Ex-Fix System (Small, Medium, Distraction Osteogenesis (DO) and Large) ; (S) intended to stabilize and provide treatment for fractures of the small bones, such as th