NA 390.002Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982197795), received between May 10, 2019 and May 13, 2019 — classified as 1 injury, 1 malfunction.

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

5 other recalls cover devices cleared under the same FDA submission (K031428, K033158, K082650, K122455); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2019Device Slipped; Device Slipped

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CLAMP PART OF THE MULTI-PIN CLAMP AND ATTACHMENT HAVE NOT COME TO A COMPLETE STOP WHEN TIGHTENING ON TO THE CARBON FIBER ROD. THE DEFECTIVE CLAMPS WERE REPLACED WITH NON-PROPERLY FUNCTIONING CLAMPS. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. CONCOMITANT DEVICES: CARBON FIBER ROD (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR A LARGE EX-FIX MULTI-PIN CLAMP. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8605476 ↗
• InjuryMay 10, 2019Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WERE (2) SEPARATE INCIDENTS WHEN THE CLAMP PART OF THE MULTI-PIN CLAMP AND ATTACHMENT DID NOT COMPLETELY STOP WHEN TIGHTENING THE CARBON FIBER ROD. THE SURGEONS HAD TO REMOVE THE EX-FIX AFTER THEY ACHIEVED REDUCTION. THEY REPLACED THE CLAMPS THEN HAD TO ATTEMPT THE REDUCTION AGAIN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN CARBON FIBER ROD (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1) . THIS REPORT IS FOR ONE (1) LARGE EX-FIX MULTI-PIN CLAMP MR-CONDITIONAL / 6-POSITION. THIS IS REPORT 1 OF 2 FOR (B)(4). THIS COMPLAINT CAPTURES THE FIRST EVENT WHILE (B)(4) CAPTURES THE SECOND EVENT.

  Patient problems: No Code Available

  MAUDE report 8601255 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K031428, K033158, K082650, K122455. 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
• Z-1833-2014 · Apr 10, 2014 · Terminated
  Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components.
• Z-0941-2013 · Jan 11, 2013 · Terminated
  Large Combination Clamp/Large External Fixation System, Part Number 390.005 Product Usage: Synthes Large External Fixation is intended for use to provide treatment for long bone
• Z-1816-2013 · Oct 12, 2012 · Open, Classified
  Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, Lot Number 6800599 Synthes Large External Fixation is intended for use to provide treatme
• Z-0277-2013 · Sep 28, 2012 · Terminated
  Synthes External Fixation System Tube to Tube Clamp, Part Number 390.007. Intended for use to provide treatment for long bone and pelvic fractures that require external fixation.