NA 390.003Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982197801), received between Mar 30, 2017 and May 13, 2019 — classified as 6 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Peeled/Delaminated” (4 reports).

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 8 most recent of 8 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 ROD ATTACHMENT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8605519 ↗
• 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 ROD ATTCHMT/MULTI PIN CLAMP/MR-CONDITIONAL. THIS IS REPORT 2 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 8601250 ↗
• InjurySep 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE TIBIA ON (B)(6) 2018. THE INITIAL NONUNION WAS CAUSED BY THE SEVERITY OF INJURY AND COMMINUTION OF BONE FRAGMENTS. NO IMPLANTS USED IN FIRST STAGE FIXATION CAUSED NONUNION. FIRST STAGE FIXATION WAS PERFORMED WITH (9) SYNTHES LARGE EXTERNAL FIXATOR ON (B)(6) 2018. BONE GRAFT WAS HARVESTED ON (B)(6) 2018 USING THE RIA SYSTEM OF WHICH THE RIA DRIVE SHAFT IS A PART. THE CHOICE TO HARVEST BONE GRAFT FROM FEMUR TO APPLY IT TO TIBIA TO PROMOTE FRACTURE HEALING. NONE OF THE EXTERNAL FIXATOR PARTS FAILED. NO PARTS ARE AVAILABLE FOR RETURN. THIS COMPLAINT INVOLVES NINE (9) DEVICES. THIS REPORT IS 3 OF 9 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7887321 ↗
• MalfunctionApr 4, 2017Failure to Align; Failure to Align

  IT WAS REPORTED THAT A PATIENT UNDERWENT SURGERY ON (B)(6) 2017 FOR THE PLACEMENT OF AN EXTERNAL FIXATOR FOR A TIBIAL PLATEAU FRACTURE, UNKNOWN SIDE. AS THE SURGEON WAS BUILDING THE FRAME AROUND THE PATIENT¿S LEG, ONE OF THE CLAMPS THAT HAD BEEN PLACED ON THE ROD WAS UNABLE TO BE LOOSENED FOR REPOSITIONING. IT WAS DESCRIBED AS SEIZED ONTO THE ROD. AS A RESULT, THE SURGEON HAD TO REPLACE BOTH THE BAR AND THE CLAMP. THERE WAS A REPORTED SEVERAL MINUTE DELAY WHILE SWAPPING OUT THE DEVICES. THE REMAINDER OF THE SURGERY WAS UNEVENTFUL AND THE PATIENT WAS REPORTED AS STABLE. CONCOMITANT DEVICE: LARGE EX-FIX 11MM CRBN FBR ROD 350MM / MR-CONDITIONAL (PART #394.86, LOT #UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) LARGE EX-FIX ROD ATTACHMENT/MULTI PIN CLAMP/MR-CONDITIONAL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6456695 ↗
• InjuryMar 30, 2017Peeled/Delaminated; Unintended Movement; Peeled/Delaminated; Unintended Movement

  THERE WAS A TEN MINUTE DELAY IN SURGERY WHILE ADDITIONAL DEVICES WERE OBTAINED.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 6445836 ↗
• InjuryMar 30, 2017Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT A PATIENT HAD THE PLACEMENT OF AN EXTERNAL FIXATOR OF THE RIGHT, DISTAL FEMUR AND TIBIAL PLATEAU ON (B)(6) 2017 AFTER A SELF-INFLICTED GUNSHOT WOUND TO THE KNEE. DURING SURGICAL ROUNDS THE FOLLOWING DAY, A VISIBLE DEFORMITY OF THE PATIENT¿S RIGHT LEG WAS NOTICED AND THAT THE CLAMPS TO THE FIXATOR HAD SLIPPED. AN X-RAY REVEALED THAT REDUCTION WAS LOST AND THE PATIENT WAS BROUGHT BACK TO THE OPERATING ROOM THE SAME DAY ON (B)(6) 2017. THE SURGEON ATTEMPTED TO REMOVE ALL FOUR CLAMPS FROM THE CARBON FIBER RODS BUT WAS ONLY ABLE TO REMOVE TWO OF THEM. THE TWO THAT WERE REMOVED WERE FOUND TO BE STRIPPED. THE TWO THAT WERE STUCK ON THE RODS WERE FOUND TO BE TIGHTENED PAST THE THREADS AND WERE LOOSE BUT UNABLE TO BE DETACHED. THE PATIENT WAS SWITCHED TO ANOTHER LARGE EXTERNAL FIXATOR AND A DIFFERENT TYPE OF CLAMP WAS USED. THE REMAINDER OF THE SURGERY WAS COMPLETED SUCCESSFULLY AND THE PATIENT REPORTED AS STABLE. THE SURGEON PLANS TO PERFORM AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE PATIENT¿S KNEE, DATE UNKNOWN. THIS COMPLAINT IS FOR FOUR DEVICES. CONCOMITANT DEVICES: CARBON FIBER ROD (PART #394.90, H133927, QUANTITY 1), CARBON FIBER ROD (PART #394.90, LOT #XXX

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 6445811 ↗
• InjuryMar 30, 2017Peeled/Delaminated; Unintended Movement; Peeled/Delaminated; Unintended Movement

  THERE WAS A TEN MINUTE DELAY IN SURGERY WHILE ADDITIONAL DEVICES WERE OBTAINED.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 6445759 ↗
• InjuryMar 30, 2017Peeled/Delaminated; Peeled/Delaminated

  THERE WAS A TEN MINUTE DELAY IN SURGERY WHILE ADDITIONAL DEVICES WERE OBTAINED.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 6445695 ↗

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.