NA 388.471Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705034773124), received between Apr 27, 2017 and May 22, 2026 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 22, 2026Material Integrity Problem

  IT WAS REPORTED THE INSTRUMENT WAS RECEIVED FROM THE LOANER PROGRAM, BUT IT WAS BROKEN. NO PATIENT HARM. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25254293 ↗
• MalfunctionJun 9, 2023Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN BRAZIL AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT THE DURING THE PROCEDURE, A PART OF THE PRODUCT BROKE. THIS REPORT IS FOR ONE (1) RIB DISTRACTION PLIERS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17098257 ↗
• MalfunctionMar 23, 2020Break; Break

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THE DISTRACTION PLIERS BROKE WHILE DISTRACTING; IT WAS NOTED THE MIDDLE PIECE FELL OFF AND THE LOCK IMPACTOR CLIP ON THE SIDE BROKE. CONCOMITANT: LOCK IMPACTOR (PART 03.641.009, LOT UNKNOWN, QUANTITY (B)(4)). THIS REPORT IS FOR A DISTRACTION PLIERS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9866261 ↗
• InjuryApr 27, 2017Break; Material Fragmentation; Break; Material Fragmentation

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR) II EXPANSION SURGERY PERFORMED ON (B)(6) 2017, THE TIP OF THE RIB EXPANSION PLIERS BROKE AFTER ONLY TWO HOLES OF DISTRACTION MADE. FRAGMENT (DEVICE TIP) WAS GENERATED AND IT WAS RETRIEVED, BUT WITH DIFFICULTY. SURGEON OPENED ORGANIC GLUE AND WERE ABOUT TO GIVE UP AND LET THE FRAGMENT INSIDE THE DISTRACTION RACK OF VEPTR COVERED WITH GLUE. IN A LAST ATTEMPT SURGEON WAS ABLE TO SUCK THE INSTRUMENT TIP. SURGERY WAS PROLONGED FOR MORE THAN 20 MINUTES DUE TO ATTEMPTS MADE BY SURGEON TO REMOVE THE PIECE OF THE INSTRUMENT FROM THE VEPTR EXTENSION HOLE. REPORTEDLY THERE WAS NO PATIENT HARM. PATIENT STATUS REPORTED AS FINE. PROCEDURE WAS COMPLETED SUCCESSFULLY THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available

  MAUDE report 6527499 ↗