NA 03.211.454Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10886982076465), received between Jan 22, 2019 and Oct 31, 2025 — classified as 2 injuries, 14 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. 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2025Break; Break

  IT WAS REPORTED DURING A PROCEDURE ON (B)(6) 2025, THREE INSTRUMENTS BROKE. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23439744 ↗
• MalfunctionOct 25, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, DURING THE PROCEDURE, THE INSTRUMENT BROKE. NO OTHER INFORMATION WAS PROVIDED AT THE TIME.

  Patient problems: Insufficient Information

  MAUDE report 20539656 ↗
• MalfunctionSep 10, 2024Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT DURING AND AFTER THE SURGERY, THE PATIENT'S CONDITION WAS STABLE AND WITHOUT ANY ADDITIONAL COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20183941 ↗
• MalfunctionSep 12, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023, THAT INTRA-OPERATIVELY, WHEN PERFORMING BONE FRAGMENT REDUCTION WITH PALAN REDUCTION 5, IT GOT BROKEN AND REMAINS INSIDE THE PATIENT. THE DOCTOR SAID THE PATIENT WAS NOT AFFECTED SINCE IT IS NOT INTRA-ARTICULAR AND IS WELL POSITIONED. THE OTHER FRAGMENT IS LABELED AND MARKED WITH RED TAPE, AS REPORTED IN THE CASE REPORT. THIS REPORT IS FOR ONE (1) REDUC JOYSTICK 5. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17731144 ↗
• MalfunctionFeb 27, 2023Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT (B)(6) 2023, DURING THE INSPECTION THE ITEMS WERE FOUND CONTAMINATED ONE(1) DAY PRIOR TO THE SURGERY. THIS REPORT IS FOR ONE (1) REDUCTION JOYSTICK/5.0MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16443746 ↗
• InjuryJan 5, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ITEM BROKE OFF IN THE PATIENT WHILE THE SURGEON WAS REDUCING THE FRACTURE. THE SURGEON OPTED TO LEAVE THE FRAGMENT IN THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE REDUCTION JOYSTICK/5.0MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 16103915 ↗
• MalfunctionNov 4, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEVICE WAS DETECTED AS INCOMPLETE DURING INSPECTION AT THE DISTRIBUTION CENTER. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE REDUCTION JOYSTICK/5.0MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15738440 ↗
• MalfunctionJun 10, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING THE SURGERY THE SPECIALIST TRIED TO MAKE TRACTION REDUCTION AND THIS ELEMENT WAS SPLIT. THIS REPORT INVOLVES ONE (1) REDUCTION JOYSTICK/5.0MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14653711 ↗
• MalfunctionFeb 5, 2021Break; Break

  IT WAS REPORTED THAT DURING SURGERY FOR A CALCANEUS FRACTURE ON (B)(6) 2021, THE REDUCTION JOYSTICK BROKE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A SIX (6) MINUTE DELAY. PATIENT WAS STABLE. THIS REPORT IS FOR A REDUCTION JOYSTICK/5.0MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11285761 ↗
• MalfunctionJun 26, 2020Break; Break

  IT WAS REPORTED THAT WHILE REDUCING A FRACTURE ON (B)(6) 2020, THE 5.0MM REDUCTION JOYSTICK PIN WAS SNAPPED IN HALF. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN SURGICAL DELAY. THIS REPORT IS FOR A REDUCTION JOYSTICK/5.0MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10202275 ↗
• MalfunctionApr 30, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE REDUCTION JOYSTICK WAS FOUND BROKEN. THE INSTRUMENT ROOM FACILITATOR WAS NOTIFIED BY THE CLEANING STAFF THAT IT CAME BROKEN TO DECONTAMINATION. IT WAS UNKNOWN THERE WAS ANY SURGERY INVOLVED. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10014684 ↗
• MalfunctionApr 14, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT THE REDUCTION JOYSTICK WAS MISSING A PIECE. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) REDUCTION JOYSTICK/5.0MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9957444 ↗
• InjurySep 27, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019 DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A CALCANEUS FRACTURE THAT THE DISTAL THREADED END OF A 5MM REDUCTION JOYSTICK SNAPPED AS IT WAS BEING PULLED TO GET A REDUCTION OF THE CALCANEUS. IT SNAPPED WHERE THE COMPRESSION NUT CONTACTS THE BONE. THE BROKEN END WAS RETRIEVED FROM THE BONE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 6.5MM REDUCTION JOYSTICK. THE PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) REDUCTION JOYSTICK/5.0MM. THIS IS REPORT 1 OF 1 FOR (B)(4)..

  Patient problems: No Code Available

  MAUDE report 9129859 ↗
• MalfunctionJul 22, 2019Break; Break

  IT WAS REPORTED THAT DURING A FOOT SURGERY ON (B)(6) 2019, THE REDUCTION JOYSTICK FROM THE VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA LCP) CALCANEAL SET BROKE IN HALF WHEN THE SURGEON ATTEMPTED TO TIGHTEN IT TO THE PATIENT'S CALCANEUS. THE JOYSTICK BROKE EXTERNALLY, AND THE BROKEN PIECE WAS EASY TO REMOVE WITH THE USE OF THE BROKEN SCREW REMOVAL SET. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH TEN (10) MINUTES OF SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR A REDUCTION JOYSTICK/5.0 MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8811500 ↗
• MalfunctionMar 5, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING INSPECTION THE REDUCTION JOYSTICK WAS FOUND TO BE BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A REDUCTION JOYSTICK. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8391714 ↗
• MalfunctionJan 22, 2019Break; Break

  IT WAS REPORTED ON (B)(6) 2019, THE PATIENT UNDERWENT OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF CALCANEUS, DURING THE PROCEDURE THE REDUCTION JOYSTICK TOOL BROKE OFF INTO PATIENT¿S CALCANEUS. BROKEN SCREW REMOVAL TRAY CALLED INTO ROOM, BUT WASN¿T NEEDED/USED. THERE WERE FRAGMENTS GENERATED FROM BROKEN DEVICE AND WAS EASILY REMOVED WITHOUT ADDITIONAL INTERVENTION. THERE WAS FIFTEEN (15) MINUTES SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR A REDUCTION JOYSTICK. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8267748 ↗