NA 394.87Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982199928), received between Jul 23, 2019 and Jul 23, 2019 — classified as 1 malfunction.

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

5 other recalls cover devices cleared under the same FDA submission (K033158, K082650, K122455, K950384); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 23, 2019Break; Break

  (B)(6)2019: UPDATED. DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN EXTERNAL FIXATION SURGERY OF A DISTAL FEMUR FRACTURE, THE BLACK COATING OF THE CONNECTING CARBON FIBRE ROD OF THE LARGE EXTERNAL FIXATOR PEELED OFF AND ENDED UP IN THE PATIENT'S WOUND. AS A RESULT, THE IMPACT WAS THERE WAS A NEED FOR IRRIGATION OF THE WOUND TO REMOVE THE PARTICLES THAT CAME FROM THE ROD PRIOR TO CLOSURE WAS PERFORMED. ALL OF THE FRAGMENTS WERE REMOVED FROM THE PATIENT. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: LARGE COMBINATION CLAMP (PART 390.005, LOT# UNKNOWN, QUANTITY# UNKNOWN), MULTI PIN CLAMP 4 POSITIONS (PART #: 390.004, LOT #: H028586 QUANTITY: 1), MULTI PIN CLAMP 6 POSITIONS (PART #: 390.002, LOT #: H805474 QUANTITY: 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8817415 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033158, K082650, K122455, K950384. 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.