MAXFRAMERecalls & reported problems across all models
Synthes GmbH · 17 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 42
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 0
We found 17 models of MAXFRAME by Synthes GmbH in the FDA's device registry (GUDID). Together they are named in 42 adverse event reports in the FDA's MAUDE database, received between May 9, 2018 and Sep 24, 2026 — classified as 3 injuries, 39 malfunctions.
The most frequently reported specific device problem is “Break” (32 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
- Break32
- Device Slipped6
- Crack5
- Mechanical Jam4
- Mechanical Problem3
- Device-Device Incompatibility2
- Appropriate Device Problem Term/Code Not Available1
- Contamination /Decontamination Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions21
- No Consequences Or Impact To Patient11
- Insufficient Information5
- No Patient Involvement3
- No Code Available2
- No Known Impact Or Consequence To Patient1
MAXFRAME models
17 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MAXFRAME 03.312.812APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT11 reports
- MAXFRAME 03.312.001ORTHOPEDIC MANUAL SURGICAL INSTRUMENT7 reports
- MAXFRAME 03.314.000Software for diagnosis/treatment5 reports
- MAXFRAME 03.312.811APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT4 reports
- MAXFRAME 03.312.180APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT2 reports
- MAXFRAME 03.313.879Software for diagnosis/treatment2 reports
- MAXFRAME 03.312.241APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT1 report
- MAXFRAME 03.312.261APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT1 report
- MAXFRAME 03.312.150APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT1 report
- MAXFRAME 03.312.210APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT1 report
- MAXFRAME 03.312.010APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT1 report
- MAXFRAME 03.312.820APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT1 report
- MAXFRAME 03.312.821APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT1 report
- MAXFRAME 03.312.830APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT1 report
- MAXFRAME 03.313.880Software for diagnosis/treatment1 report
- MAXFRAME 61.313.009TRAY, SURGICAL, INSTRUMENT1 report
- MAXFRAME 03.314.814SAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT1 report
Recent MAXFRAME adverse event reports
The 15 most recent reports across all models, 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 ↗MalfunctionJul 27, 2026Device Slipped; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50024221 ↗MalfunctionMar 13, 2026Mechanical Problem
IT WAS REPORTED THAT A MAXFRAME AUTOSTRUT HEAD UNIT WAS BEING UPLOADED WITH A REPLAN. DURING THE TESTING PROCESS OF THE INDIVIDUAL MOTORS, STRUT 1 WOULD NOT FUNCTION PROPERLY. THE MOTOR ON STRUT 1 WOULD TURN BUT IT WOULD KEEP TURNING CLOCKWISE FOR ABOUT 2-3 SECONDS. THE REST OF THE STRUTS ON THIS HEAD UNIT WOULD TURN CLOCKWISE, THEN COUNTERCLOCKWISE CORRECTLY. THEN WOULD GIVE THE APPROPRIATE ¿CHECK MARK¿ IN THE SOFTWARE PROGRAM. STRUT 1 HOWEVER, KEPT DOING AS PREVIOUSLY MENTIONED AND DID NOT GIVE THE CHECK MARK. A NEW HEAD UNIT WAS INSTALLED AND UPLOADED WITH THE REPLAN FOR THE PATIENT. ALL MOTORS FUNCTIONED PROPERLY AND THE CHECK MARKS APPEARED AS THEY WERE SUPPOSED TO PRIOR TO UPLOADING THE PROGRAM. THE PROGRAM WAS THEN UPLOADED AND STARTED. POST OP, THEY REPLANNED WITH THE EXISTING HEAD UNIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24592815 ↗MalfunctionFeb 19, 2026Break; Device Slipped
IT WAS REPORTED A POST-OPERATIVE EVENT OCCURRED INVOLVING A MAX FRAME SYSTEM INSTALLED ON A PATIENT'S LEG. DURING ROUTINE FOLLOW-UP, THE PATIENT REPORTED A PERCEIVED LOOSENING IN THE SYSTEM. UPON REVIEW OF AN IMAGE, THE SURGEON IDENTIFIED THAT STRUT NUMBER 4 HAD BROKEN. THE DEFECTIVE STRUT WAS REPLACED WITH A FUNCTIONAL ONE OF THE SAME CATALOG NUMBER. THERE WAS NO REPORTED CONSEQUENCE OR IMPACT TO THE PATIENT, AND NO SIGNS, SYMPTOMS, OR PATIENT INVOLVEMENT WERE IDENTIFIED. THE COMPLAINT DEVICE STATUS IS NOT SPECIFIED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24390835 ↗MalfunctionJan 5, 2026Break
IT WAS REPORTED THAT A WIRE OF THE HEAD UNIT SNAPPED. THERE WAS NO PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23957876 ↗MalfunctionSep 23, 2025Break; Mechanical Jam; Appropriate Device Problem Term/Code Not Available; Break; Mechanical Jam; Appropriate Device Problem Term/Code Not Available
IT WAS REPORTED THAT THE WIRES WERE EXPOSED ON THE MAXFRAME CONTROL UNIT. HEAD UNIT WAS SHOWING AN ERROR, AND PATIENT CALLED WITH A CONCERN, MENTIONING EXPOSED WIRES. PATIENT CAME INTO CLINIC, ERROR WAS DETERMINED TO NOT BE BECAUSE OF THE EXPOSED WIRES (ANOTHER STRUT WAS STUCK). REPLACED THE HEAD UNIT FOR SAFETY CONCERNS AND TO HELP PREVENT A FUTURE ERROR. ISSUE WAS RESOLVED WITH INSTALLING A NEW CONTROL UNIT. THE PATIENT HAD DELAYED TREATMENT BY A COUPLE DAYS AND HAD TO MAKE A TRIP TO THE CLINIC, BUT HAD NO ADVERSE OUTCOMES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23120742 ↗MalfunctionAug 5, 2025Break; Crack; Break; Crack
IT WAS REPORTED THAT ON AN UNKNOWN DATE, A MAXFRAME AUTOSTRUT WAS DAMAGED. THERE WAS SIGNIFICANT FRAYING OF THE RUBBER PROTECTIVE SLEEVE HOUSING THE ELECTRICAL WIRES ON THE DEVICE. THERE WAS ALSO A CRACK ON ONE OF THE MOTORS ON THE DEVICE. ADDITIONALLY, A DIAGNOSTIC TEST WAS RAN AN ISSUE WAS IDENTIFIED WITH THE MOTOR LABELED "4" THAT COULD HAVE POTENTIALLY THREW A RED LIGHT ON THE DEVICE AND RESTRICTED ANY FURTHER MOVEMENT OF THE FRAME. THE MOVEMENT CAPABILITIES OF THE MOTOR/STRUT WERE TESTED MANUALLY. HOWEVER, THERE SEEMED TO NOT BE AN ISSUE WITH THE MOTOR ITSELF AS THE DIAGNOSTIC TEST HAD ORIGINALLY CONCLUDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22719506 ↗MalfunctionFeb 20, 2025Break; Crack; Device-Device Incompatibility; Break; Crack; Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE INSTRUMENT WAS UNABLE TO BE STERILIZE/ASSEMBLED. THERE WAS CHIPPING AND CRACKING. IT WAS UNABLE TO BE USED. THE PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN.
Patient problems: Insufficient Information
MAUDE report 21423099 ↗MalfunctionSep 23, 2024Break; Break
IT WAS REPORTED THAT ON (B)(6) 2024 UPON STRUT TIGHTENING, THE THREADED ROD BROKEN AT THE LEVEL OF THE BALL JOINT. THE EVENT DID NOT OCCUR DURING STERILE PROCESSING. THE EVENT DID NOT OCCUR DURING FILED INSPECTION. THERE WAS NO PATIENT CONSEQUENCES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20284856 ↗MalfunctionSep 9, 2024Break; Break
IT WAS REPORTED THAT ON UNKNOWN DATE WHILE ORGANIZING, SETS AND INSTRUMENTS WE NOTICED SOME BROKEN AND DAMAGED PIECES NOT USEABLE FOR CASES. IT WAS OCCURRED DURING METRO CLEANUP. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20171484 ↗MalfunctionAug 28, 2024Break; Break
IT WAS REPORTED THAT ON (B)(6) 2024, THE RUBBER ON THE FOOT ROCKER IS REMOVING AND THE PATIENT SLEPT POSTOPERATIVELY. THIS REPORT IS FOR ONE (1) MAXFRAME(TM)FOOT PLATE SUPPORT KIT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20091870 ↗MalfunctionJun 11, 2024Crack; Contamination /Decontamination Problem; Device-Device Incompatibility; Crack; Contamination /Decontamination Problem; Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE PRODUCT WAS UNABLE TO STERILIZE/ASSEMBLE. THERE WAS CHIPPING AND CRACKING. IT WAS UNABLE TO USE. THIS REPORT IS FOR ONE (1) MAXFRAME(TM) FOOT PLATE LONG 120MM/ALUMINUM THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19510506 ↗MalfunctionMar 15, 2024Break; Break
IT WAS REPORTED THAT ON (B)(6) 2024, THE PINS IN QUESTION WERE REPORTED TO HAVE BROKEN. THERE WAS NO REPORTED PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE.THIS REPORT IS FOR A MAXFRAME(TM) POLYAXIAL STRUT FINE AND GROSS ADJUST/SHORT.THIS IS REPORT 2 OF 2 FOR (B)(4) .
Patient problems: Insufficient Information
MAUDE report 18915446 ↗MalfunctionMar 15, 2024Break; Break
IT WAS REPORTED THAT ON 02-FEBRUARY-2024, THE PINS IN QUESTION WERE REPORTED TO HAVE BROKEN. THERE WAS NO REPORTED PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A MAXFRAME(TM) POLYAXIAL STRUT FINE AND GROSS ADJUST/SHORT. THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: Insufficient Information
MAUDE report 18915442 ↗MalfunctionMar 14, 2024Break; Break
IT WAS REPORTED THAT THE POLYAXIAL STRUT BROKE ON AN UNKNOWN DATE IN 2024. THE SALES REP WAS MADE AWARE AT THE REMOVAL.THIS REPORT IS FOR ONE MAXFRAME POLYAX STRUT FN & GROSS AD/MED FOR (B)(4).
Patient problems: Insufficient Information
MAUDE report 18908776 ↗
Other Synthes GmbH products
All Synthes GmbH 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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