NA 03.111.021Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10886982072207), received between Aug 20, 2018 and Sep 30, 2026 — classified as 32 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Material Twisted/Bent

  It was reported that the teeth on distractor piece was wearing down and no longer effectively locking. There was no patient harm or delay.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50946850 ↗
• MalfunctionMay 29, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED ON AN UNKNOWN DATE THAT THE LID TO REPORTER ACCOUNT'S FOOT MODULE COMPRESSION/DISTRACTION DEVICE WAS WARPED AND WOULD NOT SLIDE AND LOCK INTO THE MODULE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25331026 ↗
• MalfunctionMar 30, 2026Break

  IT WAS REPORTED THAT THE INSTRUMENT WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24731620 ↗
• MalfunctionJan 15, 2026Break

  IT WAS REPORTED THAT DURING AN ORIF CALC / POLYTRAUMA ON AN UNKNOWN DATE, A JOINT DISTRACTOR WAS DISTRACTING AND THE SPRING COMPONENT BROKE. BEFORE THE CASE, RUST WAS FOUND IN A FEW DRILL GUIDES. THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24085012 ↗
• MalfunctionJan 13, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE SALES REPRESENTATIVE CONDUCTED A DEMONSTRATION OF THE PRODUCT IN QUESTION FOR THE OPERATING ROOM STAFFS. WHEN THE ANGLE OF THE WIRE INSERTION POINT WAS CHANGED, THE ADJUSTMENT LEVER WOULD NOT FULLY GO DOWN. THE ADJUSTMENT LEVER WORKED FINE DEPENDING ON THE ANGLE, BUT THE STAFFS WERE CONCERNED THAT THE LEVER MAY NOT WORK DURING SURGERY AND DECIDED TO RETURN THE PRODUCT. THIS EVENT IS NOT RELATED TO ANY SPECIFIC SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24053794 ↗
• MalfunctionJun 17, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE INSTRUMENTS WERE DULL AND NEED TO BE REPLACED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22236077 ↗
• MalfunctionJun 17, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT INSTRUMENTS WERE DULL AND NEED REPLACEMENT. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY DUE TO THE REPORTED EVENT. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22235512 ↗
• MalfunctionJun 17, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT INSTRUMENTS WERE DULL AND NEED REPLACEMENT. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY DUE TO THE REPORTED EVENT. IT IS UNKNOWN IF THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22235333 ↗
• MalfunctionMay 21, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT (B)(6) 2025, THE DISTRACTOR WAS FOUND NOT TO BE WORKING POST-OPERATIVELY IN THE STERILE PROCESSING DEPARTMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22064134 ↗
• MalfunctionFeb 5, 2025Mechanical Problem; Device-Device Incompatibility; Mechanical Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DISTRACTOR/COMPRESSOR INSTRUMENT WOULD NOT WORK DURING THE PROCEDURE. THE RATCHET WOULD NOT ENGAGE ALLOWING FOR DISTRACTION OR COMPRESSION. THERE WAS NO PATIENT STATUS/ OUTCOME OR CONSEQUENCES. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21315990 ↗
• MalfunctionSep 9, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AUG 14, 2024, WHILE CHECKING THE FOOT DISTRACTOR/COMPRESSOR TO MAKE SURE IT WORKS PROPERLY, IT WAS NOTICED THAT THE GEARING MECHANISM APPEARS TO STRIP WHEN USING DISTRACTION/DISTRACTION WHEEL. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) COMPRESSION/DISTRACTION INSTRUMENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20172671 ↗
• MalfunctionNov 20, 2023Break; Break

  IT WAS REPORTED THAT ON OCT 30, 2023, DURING INSPECTION THE COMPRESSION FOUND TO BE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) COMPRESSION/DISTRACTION INSTRUMENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18171393 ↗
• MalfunctionJul 25, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SMALL DISTRACTION DEVICE COMPRESSION PIECE WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE COMPRESSION/DISTRACTION INSTRUMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17388468 ↗
• MalfunctionJul 12, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, THERE WAS A SMALL COMPRESSOR/DISTRACTOR BREAK DURING A CASE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH BACKUP. NO PATIENT CONSEQUENCE WAS REPORTED. THIS REPORT IS FOR ONE (1) COMPRESSION/DISTRACTION INSTRUMENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17307533 ↗
• MalfunctionMay 8, 2023Break; Break

  IT WAS REPORTED, THAT ON UNKNOWN DATE DURING THE CASE. THE COMPRESSION/DISTRACTOR BROKE, ALONG WITH THE 3.0MM SLEEVES USED FOR IT. THE PIECE SEEMS TO BE MISSING INSIDE THE DISTRACTOR, SO THERE IS NO ¿RATCHET¿ WHEN YOU SPIN THE DISTRACTOR. ALSO, THE SLEEVES SEEM BENT AND A 3.0MM WIRE CAN'T FIT THROUGH THEM. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS COMPLAIN INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR ONE (1) COMPRESSION/DISTRACTION INSTRUMENT. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16891394 ↗
• MalfunctionNov 23, 2022Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE THAT THESE ARE BROKEN OR UNUSABLE PRODUCTS. . IT IS UNKNOWN WHEN THE ISSUE WAS DISCOVERED. THERE WAS NO PATIENT OUTCOME/CONSEQUENCE. THIS REPORT IS FOR ONE (1)COMPRESSION/DISTRACTION DEVICE F/FOOT+AN THIS IS REPORT 5 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15850762 ↗
• MalfunctionSep 30, 2022Break; Break

  DEVICE REPORT FROM NORWAY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT FOLLOWING SURGERY ON (B)(6) 2022, THE EXTRACTOR BECAME DISSEMBLED DURING CLEANING IN THE WASHING-MACHINE. THERE WAS NO IMPACT TO PATIENT OR PROCEDURE. UPON MANUFACTURER INVESTIGATION, IT WAS DETERMINED THAT THE COMPRESSION/DISTRACTION DEVICE F/FOOT+AN HAD THE SPRING AND THE ARM FALL APART FROM THE BODY SHAFT. THIS REPORT IS FOR A COMPRESSION/DISTRACTION INSTRUMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15511848 ↗
• MalfunctionAug 2, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING A CALCANEAL FRACTURE, THE TENSIONING KNOB ON THE COMPRESSION/DISTRACTION DEVICE BROKE OFF. THEY WERE STILL ABLE TO MANIPULATE BUT NO IDEAL HAVING TO HOLD THAT KNOB IN PLACE. PATIENT CONSEQUENCES/OUTCOMES IS UNKNOWN. THIS REPORT IS FOR ONE COMPRESSION/DISTRACTION INSTRUMENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15152701 ↗
• MalfunctionJul 12, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PIN WAS BENT INSIDE THE DISTRACTOR, AND IT COULD NOT BE REMOVED. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO PATIENT OUTCOME. THIS REPORT IS FOR ONE (1) COMPRESSION/DISTRACTION INSTRUMENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14986730 ↗
• MalfunctionMay 12, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN NETHERLANDS AS FOLLOWS: IT WAS REPORTED THAT A COMPRESSION/DISTRACTION INSTRUMENT WAS CHECKED AND IT WAS FOUND OUT THAT THE DISTRACTOR IS VERY HARD TO TAKE APART. IT TOOK TOO MUCH FORCE TO TAKE IT APART. PRODUCT HAS NOT BEEN USED SO FAR IN THE HOSPITAL. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) COMPRESSION/DISTRACTION INSTRUMENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14379377 ↗
• MalfunctionMar 10, 2022Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, THE DISTRACTION DEVICE WAS BROKEN. THE SCREW THAT HOLDS THE WING NUT WAS FALLING OFF. PROCEDURE WAS COMPLETED WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A COMPRESSION/DISTRACTION INSTRUMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13720760 ↗
• MalfunctionDec 14, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE COMPRESSION/DISTRACTION DEVICE FOR FOOT AND ANKLE LEVER BROKE. IT IS UNKNOWN WHEN THE ISSUE WAS OBSERVED. IT IS UNKNOWN IF THERE IS PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) COMPRESSION/DISTRACTION INSTRUMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13004117 ↗
• MalfunctionMar 23, 2021Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE COMPRESSION/DISTRACTION INSTRUMENT MALFUNCTIONED AND WAS UNABLE TO BE ASSEMBLED PROPERLY, THE HINGE WAS JAMMED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A COMPRESSION/DISTRACTION INSTRUMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11555954 ↗
• MalfunctionDec 1, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE UPON ROUTINE INSPECTION, THE COMPRESSION/ DISTRACTION INSTRUMENT WILL NOT HOLD TENSION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) COMPRESSION/DISTRACTION INSTRUMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10928505 ↗
• MalfunctionOct 21, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE COMPRESSION/DISTRACTION INSTRUMENT MALFUNCTIONED. THERE WAS NO PATIENT CONSEQUENCE. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) COMPRESSION/DISTRACTION INSTRUMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10713906 ↗