NA 395.107Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982200143), received between Dec 7, 2017 and Jul 20, 2018 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Operates Differently Than Expected” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• 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 45MM. THIS IS REPORT 4 OF 10 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7707443 ↗
• 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 45MM. THIS IS REPORT 3 OF 10 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7707419 ↗
• InjuryDec 7, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DEVICE REPORT FROM SYNTHES (B)(4) 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 4 OF 8 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7097808 ↗
• InjuryDec 7, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DEVICE REPORT FROM SYNTHES (B)(4) 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 5 OF 8 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7097802 ↗
• 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 3 OF 8 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7097377 ↗

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