MAXFRAMERecalls & reported problems across all models
Synthes (U.S.A.) LP · 4 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 30
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls
- 0
We found 4 models of MAXFRAME by Synthes (U.S.A.) LP in the FDA's device registry (GUDID). Together they are named in 30 adverse event reports in the FDA's MAUDE database, received between Feb 8, 2023 and May 12, 2025 — classified as 2 injuries, 28 malfunctions.
The most frequently reported specific device problem is “Break” (22 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported MAXFRAME problems
Device problems
- Break22
- Device Slipped5
- Appropriate Device Problem Term/Code Not Available2
- Device-Device Incompatibility2
- Mechanical Problem2
- Crack1
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- Insufficient Information6
MAXFRAME models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MAXFRAME 1100007-01Software for diagnosis/treatment14 reports
- MAXFRAME 1100010-01Software for diagnosis/treatment10 reports
- MAXFRAME 1100012-01Software for diagnosis/treatment4 reports
- MAXFRAME 1100011-01Software for diagnosis/treatment2 reports
Recent MAXFRAME adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionMay 12, 2025Crack; Crack
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE MAXFRAME AUTOSTRUT HEAD UNIT SHOWED ORANGE AND RED LIGHT. SEEMED TO BE THAT THE STOP BUTTON WAS PUSHED. WHEN WE WENT TO REPROGRAM THE HEADUNIT, IT WOULD NOT PASS THE SCREEN "STOP BUTTON PUSHED, PLEASE PRESS THE STOP BUTTON AGAIN TO CONTINUE". THEY DID THAT MULTIPLE TIMES WHILE EXITING OUT OF THE APP ON THE LAPTOP AND TRYING AGAIN. THEN THEY RESET THE HEAD UNIT, AND STILL NO HELP. THEY NOTICED THERE WAS A FRAY IN THE WIRE. THE PATIENT DID NOT EXPERIENCE AN ADVERSE EVENT. THE PATIENT DID NOT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22003226 ↗MalfunctionJan 23, 2025Break; Break
IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2025, THERE WAS A BROKEN STRUT. NO FRAGMENTS WERE LEFT IN THE PATIENT. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN DELAY. PATIENT IS DOING FINE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21218551 ↗MalfunctionJan 9, 2025Break; Break
IT WAS REPORTED THAT POSTOPERATIVELY, THE PATIENT CAUGHT THE CORD OF THE DEVICE ON HER WALKER AND SEVERED THE CORD. THE UNIT WENT RED AND STOPPED WORKING.
Patient problems: Insufficient Information
MAUDE report 21118089 ↗MalfunctionNov 5, 2024Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT ON (B)(6) 2024 THE AUTOSTRUT CONTAINED EXPOSED WIRES ON ONE OF THE MOTORS. THERE WAS NO INVOLVEMENT OF ANY OPERATION AND PATIENT. THERE WAS NO PATIENT CONSEQUENCES. NO OTHER INFORMATION WAS PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20609408 ↗MalfunctionAug 22, 2024Break; Break
IT WAS REPORTED THAT ON (B)(6) 2024, THE LOCK IN THE SET BROKE. THIS REPORT INVOLVES ONE (1) MAXFRAME AUTOSTRUT(TM)HEXAPOD CRLSYS KIT. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Insufficient Information
MAUDE report 20024593 ↗MalfunctionAug 15, 2024Break; Break
IT WAS REPORTED THAT ON JULY 18, 2024, ONE OF THE GEAR LOCKS ON A MAXFRAME HEXAPOD KIT BROKE. THERE WAS NO MEDICAL INTERVENTION. THE PATIENT REPLACED THE GEAR LOCKS. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A MAXFRAME AUTOSTRUT(TM) AUTOMATED HEXAPOD CTRL SYS KIT. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19994911 ↗MalfunctionOct 9, 2023Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE AUTOSTRUT IN QUESTION BROKE AT THE CLEVIS. THERE WAS NO REPORTED ADVERSE IMPACT TO THE PATIENT. NO REVISION SURGERY WAS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A MAXFRAME AUTOSTRUT(TM) HEXAPOD STRUT ¿ MEDIUM. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Insufficient Information
MAUDE report 17894757 ↗MalfunctionOct 3, 2023Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2023, THE MEDIUM AUTOSTRUT BROKE AT THE CLAVICLE. THERE WERE NO REPORTED PATIENT CONSEQUENCES, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A MAXFRAME AUTOSTRUT(TM) HEXAPOD STRUT ¿ MEDIUM. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Insufficient Information
MAUDE report 17859560 ↗MalfunctionAug 22, 2023Break; Break
IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT CAME TO THE CLINIC WITH A BROKEN AUTOSTRUT. THE MED AUTOSTRUT BROKE AT THE SHOULDER BOLT INTERFACE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE MAXFRAME AUTOSTRUT(TM) HEXAPOD STRUT - MEDIUM. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17596404 ↗MalfunctionAug 18, 2023Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility
IT WAS REPORTED ON AN UNKNOWN DATE IN 2023, THAT THE SURGEON WAS PROGRAMMING THE AUTOSTRUT HEAD UNIT. MOTOR NUMBER 3 WOULD NOT PASS THE INITIAL TEST IN THE FIRST SCREEN IN THE SOFTWARE. THE SURGEON WAS ADVISED TO CHECK THE MOTOR CLIP TO MAKE SURE THE MOTOR WAS SITTING IN THE STRUT APPROPRIATELY, HE CONFIRMED IT WAS. HE THEN RAN MANUAL MODE FORWARD AND BACKWARDS ONE TIME TO SEE IF THE MOTOR WAS TURNING THE GEAR IN THE STRUT. IT WAS CONFIRMED THE MOTOR WAS LIGHTING UP GREEN AND IT MOVED. HE THEN TESTED AGAIN, BUT THE STRUT DID NOT PASS. HE REPLACED THE SHORT STRUT TO SEE IF THE STRUT WAS THE ISSUE, BUT IT STILL WAS NOT PASSING THE INITIAL TEST. THE MOTOR WAS REMOVED AND USED THE BLUE KNOB TO BE SURE THERE WAS NOT TOO MUCH TENSION ON THE STRUT. CONFIRMED THERE WAS NOT TOO MUCH TENSION. THE SURGEON THEN USED MOTOR NUMBER 4 IN STRUT NUMBER 3 DURING THE TEST TO SEE IF IT COULD PASS, AND IT DID. IT WAS ADVISED AT THAT TIME TO REPLACE THE HEAD UNIT. THE NEW HEAD UNIT WAS APPLIED AND LOADING OF THE PROGRAM PASSED AND WAS SUCCESSFUL. THIS REPORT IS FOR ONE (1) MAXFRAME AUTOSTRUT(TM) HEXAPOD STRUT - SHORTTHIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17573738 ↗MalfunctionAug 18, 2023Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility
IT WAS REPORTED ON AN UNKNOWN DATE IN 2023, THAT THE SURGEON WAS PROGRAMMING THE AUTOSTRUT HEAD UNIT. MOTOR NUMBER 3 WOULD NOT PASS THE INITIAL TEST IN THE FIRST SCREEN IN THE SOFTWARE. THE SURGEON WAS ADVISED TO CHECK THE MOTOR CLIP TO MAKE SURE THE MOTOR WAS SITTING IN THE STRUT APPROPRIATELY, HE CONFIRMED IT WAS. HE THEN RAN MANUAL MODE FORWARD AND BACKWARDS ONE TIME TO SEE IF THE MOTOR WAS TURNING THE GEAR IN THE STRUT. IT WAS CONFIRMED THE MOTOR WAS LIGHTING UP GREEN AND IT MOVED. HE THEN TESTED AGAIN, BUT THE STRUT DID NOT PASS. HE REPLACED THE SHORT STRUT TO SEE IF THE STRUT WAS THE ISSUE, BUT IT STILL WAS NOT PASSING THE INITIAL TEST. THE MOTOR WAS REMOVED AND USED THE BLUE KNOB TO BE SURE THERE WAS NOT TOO MUCH TENSION ON THE STRUT. CONFIRMED THERE WAS NOT TOO MUCH TENSION. THE SURGEON THEN USED MOTOR NUMBER 4 IN STRUT NUMBER 3 DURING THE TEST TO SEE IF IT COULD PASS, AND IT DID. IT WAS ADVISED AT THAT TIME TO REPLACE THE HEAD UNIT. THE NEW HEAD UNIT WAS APPLIED AND LOADING OF THE PROGRAM PASSED AND WAS SUCCESSFUL. THIS REPORT IS FOR ONE (1) MAXFRAME AUTOSTRUT(TM)HEXAPOD CRLSYS KIT. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17573731 ↗InjuryAug 3, 2023Break; Break
IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT ARRIVED AT THE CLINIC WITH A BROKEN STRUT. STRUT #5 IS THE MEDIAL POSTERIOR AND IS THE SAME THAT BROKE PREVIOUSLY AND WAS REPORTED ON A PREVIOUS COMPLAINT. THE PATIENT STATED THAT THE STRUT HAD BROKEN EARLIER IN THE MORNING DURING PHYSICAL THERAPY. A NEW STRUT WAS PLACED AT STRUT #5 AND THE BROKEN STRUT WAS REMOVED AND IS AVAILABLE FOR RETURN. THIS PATIENT IS NOT SCHEDULED FOR ANYMORE STRUT CHANGES. REPROGRAMING THE HEAD UNIT WAS SUCCESSFUL AND THERE WAS NO NEGATIVE IMPACT TO THE PATIENT OR THE MAXFRAME PLAN. THIS REPORT IS FOR ONE (1) MAXFRAME AUTOSTRUT(TM) HEXAPOD STRUT - LONG. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: Insufficient Information
MAUDE report 17454011 ↗MalfunctionJul 20, 2023Break; Break
IT WAS REPORTED THAT ON JUNE 28, 2023, THE THREADS SNAPPED OFF THE DEVICE AND THE BALL SWIVEL FELL OUT. THERE WAS NO OPERATION OR PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE MAXFRAME AUTOSTRUT(TM) HEXAPOD STRUT - MEDIUM. THIS IS REPORT 2 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17360780 ↗InjuryJul 6, 2023Break; Break
IT WAS REPORTED THAT THE PATIENT STATED HE WAS SLIDING DOWN THE STAIRS TO GET TO THE MAIN FLOOR AND STRUT NUMBER 5 HAD BROKEN. THE PATIENT'S MOTHER STATED THAT DONTORIOUS BANGS THE STRUT ON EVERY STEP ON THE WAY DOWN. THE MOTHER ZIP-TIED THE STRUT TO THE RING, AND IT WAS BROKEN FOR A TOTAL OF TWO DAYS. THE SURGEON CHECKED THE STRUT LENGTHS OF ALL SIX STRUTS, AND THE PROGRAM HAD KEPT THEM WITHIN 1-2MM OF THE PLANNED ROBOTIC SCHEDULE. STRUT NUMBER 5, EVEN THOUGH IT HAD BROKEN TWO DAYS PRIOR TO THE STRUT CHANGE, WAS ALSO WITHIN THE 1-2MM DIFFERENCE, AND THE SURGEON FELT IT HAD NO NEGATIVE IMPACT ON PATIENT CARE. STRUT 5 WAS A MEDIUM STRUT, AND IT BROKE THROUGH THE SHOULDER BOLT KNUCKLE CONNECTION. THE PRODUCT IS AVAILABLE FOR RETURN. THE SCHEDULED STRUT CHANGE WAS SUCCESSFUL, AND NO HARM TO THE PATIENT WAS OBSERVED. STRUT 5 WAS A SCHEDULED STRUT CHANGE ON THIS DATE, AND IT WAS REPLACED WITH A LARGE AUTO STRUT. THIS ALSO NEEDED A NEW SHOULDER BOLT BECAUSE OF THE STRUT FAILURE, SO THEY WILL HAVE BOTH THE STRUT AND THE SHOULDER BOLT AVAILABLE FOR RETURN. THIS REPORT IS FOR ONE (1) MAXFRAME AUTOSTRUT(TM)HEXAPOD STRUT-MED THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: Insufficient Information
MAUDE report 17270000 ↗MalfunctionJul 6, 2023Break; Break
IT WAS REPORTED ON AN UNKNOWN DATE, THE PATIENT CAME INTO CLINIC WITH THREE BROKEN STRUTS. THE PATIENT CLAIMED THAT HE WAS SITTING BY SPACE HEATER WHEN THREE OF HIS MEDIUM AUTOSTRUTS CRACKED AT THE BASE OF BOLT CONNECTION. HE IS NOT BEARING ANY WEIGHT AND THIS IS THE SECOND OCCURRENCE OF THIS EVENT. PATIENT CLAIMED TO NOT BE TIGHTENING THE STRUTS HIMSELF. THERE WAS NO PATIENT OUTCOME OR CONSEQUENCES. THIS REPORT IS FOR ONE (1) MAXFRAME AUTOSTRUT(TM)HEXAPOD STRUT-MED THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17265572 ↗
Other Synthes (U.S.A.) LP products
All Synthes (U.S.A.) LP devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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