MAXFRAME 03.312.812Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886982261038), received between Aug 21, 2018 and Sep 24, 2026 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Break

  It was reported on an unknown date that Product broke as it was being removed from the maxframe.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50881501 ↗
• MalfunctionMay 19, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THAT THE DEVICE HAS A BROKEN STRUT. THERE WERE NO FRAGMENTS GENERATED. THERE WAS NO PATIENT CONSEQUENCES OR SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) MAXFRAME(TM) QUICK ADJUST STRUT/MEDIUM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16965047 ↗
• MalfunctionAug 30, 2022Break; Break

  DEVICE REPORT FROM THE UNITED ARAB EMIRATES REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, THE STRUT IN QUESTION GOT BROKEN WHILE TIGHTENING USING THE TORQUE LIMITING WRENCH. FRAGMENTS WERE GENERATED, BUT WERE EASILY REMOVED WITHOUT ADDITIONAL INTERVENTION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A MAXFRAME(TM) QUICK ADJUST STRUT/MEDIUM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15319879 ↗
• MalfunctionJul 16, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE WHILE DOING A MAXFRAME STRUT SWAP, THE NEW STRUT BEING PUT ON AND TORQUED BROKE. THERE WAS NO HARM TO THE PATIENT. ANOTHER STRUT WAS USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY REPORTED. THIS REPORT IS FOR ONE (1) MAXFRAME(TM) QUICK ADJUST STRUT/MEDIUM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12181844 ↗
• MalfunctionMar 19, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT A MAXFRAME STRUT WITH QUICK ADJUST WAS BROKEN THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9857727 ↗
• MalfunctionMar 19, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT A MAXFRAME STRUT WITH QUICK ADJUST WAS BROKEN THERE WAS NO KNOWN PATIENT OR HOSPITAL INVOLVEMENT.THIS COMPLAINT INVOLVES ONE (1) DEVICE.THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9857724 ↗
• MalfunctionMar 10, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING ROUTINE INCOMING INSPECTION, THE MAXFRAME WITH QUICK ADJUST WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS IS 1 OF 1 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 9812803 ↗
• MalfunctionApr 1, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE, WHEN THE TORQUE LIMITER WAS PLACED ON TOP, AND WRENCH ON BOTTOM. THE MAXFRAME QUICK ADJUST STRUTS WAS SNAPPED IN THE MIDDLE OF THE CASE AFTER THE SAME HAD BEND OPEN WITH SEVEN OTHER STRUTS. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR ONE (1) MAXFRAME QUICK ADJUST STRUT/MEDIUM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8470793 ↗
• MalfunctionMar 18, 2019Break; Break

  IT WAS REPORTED THAT DURING AN ANKLE RECONSTRUCTION PROCEDURE ON (B)(6) 2019, THE RESIDENT DID NOT USE COUNTER TORQUE ON THE MAXFRAME QUICK ADJUST STRUT WHEN TIGHTENING DOWN WITH THE TORQUE LIMITING WRENCH AND BROKE TWO (2) STRUTS. BROKEN STRUTS WERE REPLACED WITH A NEW STRUT AND INSTRUCTIONS WERE PROVIDED FOR CORRECT TIGHTENING. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN TORQUE DEVICE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (1) MAXFRAME (TM) QUICK ADJUST STRUT/MEDIUM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8430076 ↗
• MalfunctionMar 18, 2019Break; Break

  IT WAS REPORTED THAT DURING AN ANKLE RECONSTRUCTION PROCEDURE ON (B)(6) 2019, THE RESIDENT DID NOT USE COUNTER TORQUE ON THE MAXFRAME QUICK ADJUST STRUT WHEN TIGHTENING DOWN WITH THE TORQUE LIMITING WRENCH AND BROKE TWO (2) STRUTS. BROKEN STRUTS WERE REPLACED WITH A NEW STRUT AND INSTRUCTIONS WERE PROVIDED FOR CORRECT TIGHTENING. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN TORQUE DEVICE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS REPORT IS FOR ONE (1) MAXFRAME (TM) QUICK ADJUST STRUT/MEDIUM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8430049 ↗
• MalfunctionAug 21, 2018Break; Break

  IT WAS REPORTED THAT A SURGEON INDICATED THAT MAXFRAME WAS PLACED ON A PATIENT APPROXIMATELY 5 MONTHS AGO. PATIENT RECENTLY RETURNED TO THE OFFICE TO REPORT THAT ONE OF THE RINGS ON THE FRAME HAD BROKEN. THE SURGEON HAS REINFORCED THE FRAME AND WILL CONTINUE TO MONITOR THE PATIENT UNTIL BONE CONSOLIDATION IS REACHED. SURGERY AND PATIENT OUTCOME WERE NOT REPORTED. UPON RECEIPT OF THE DEVICES AT THE MANUFACTURER, IT WAS IDENTIFIED THAT AN UNKNOWN SCREW AND MAXFRAME(TM) QUICK ADJUST STRUT/MEDIUM WERE BROKEN. THIS REPORT IS FOR ONE (1) MAXFRAME (TM) QUICK ADJUST STRUT/MEDIUM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7802676 ↗