EXPertRecalls & reported problems across all models
Synthes GmbH · 8 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 33
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls
- 0
We found 8 models of EXPert by Synthes GmbH in the FDA's device registry (GUDID). Together they are named in 33 adverse event reports in the FDA's MAUDE database, received between Jan 5, 2017 and Jan 14, 2026 — classified as 5 injuries, 28 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (17 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 EXPert problems
Device problems
- Device-Device Incompatibility17
- Break9
- Failure to Align6
- Material Twisted/Bent5
- Crack4
- Contamination /Decontamination Problem2
- Device Slipped2
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions24
- No Code Available5
- No Known Impact Or Consequence To Patient3
- No Patient Involvement1
EXPert models
8 models, most reported first. Each model has its own page with its reports, recalls and device details.
- EXPert 03.010.483ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES8 reports
- EXPert 03.010.488ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES7 reports
- EXPert 03.010.004NAIL, FIXATION, BONE5 reports
- EXPert 03.010.482ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES5 reports
- EXPert 03.010.485NAIL, FIXATION, BONE4 reports
- EXPert 03.010.507Screw, fixation, bone2 reports
- EXPert 03.010.504ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- EXPert 03.010.509ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
Recent EXPert adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJan 14, 2026Break
USED AN AIMING ARM AND THE CLIPS THAT HOLD THE TROCARS IN PLACE BROKE OFF. THERE WAS NO PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24067063 ↗MalfunctionDec 17, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PRODUCT HAS MISSED THE NAIL IN THE PAST 2 CASES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23829135 ↗MalfunctionDec 17, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PRODUCT HAS MISSED THE NAIL IN THE PAST 2 CASES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23829067 ↗MalfunctionDec 17, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PRODUCT HAS MISSED THE NAIL IN THE PAST 2 CASES THEY HAVE DONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23828947 ↗MalfunctionDec 17, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THE PRODUCT HAS MISSED THE NAIL IN THE PAST 2 CASES THEY HAVE DONE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23828889 ↗MalfunctionJun 13, 2025Break; Crack; Contamination /Decontamination Problem; Device-Device Incompatibility; Break; Crack; Contamination /Decontamination Problem; Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE, ITEMS WERE UNABLE TO STERILIZE/ASSEMBLE. THESE ITEMS WERE CHIPPING AND CRACKING AND UNABLE TO BE USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22202795 ↗MalfunctionJun 13, 2025Break; Crack; Contamination /Decontamination Problem; Device-Device Incompatibility; Break; Crack; Contamination /Decontamination Problem; Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE, ITEMS WERE UNABLE TO STERILIZE/ASSEMBLE. THESE ITEMS WERE CHIPPING AND CRACKING AND UNABLE TO BE USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22202791 ↗MalfunctionJun 4, 2025Break; Crack; Device-Device Incompatibility; Break; Crack; Device-Device Incompatibility
IT WAS REPORTED THAT USER WAS UNABLE TO STERILIZE/ASSEMBLE. IT WAS CHIPPING AND CRACKING. USER WAS UNABLE TO USE AND NEEDED REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22143778 ↗MalfunctionJun 4, 2025Break; Crack; Device-Device Incompatibility; Break; Crack; Device-Device Incompatibility
IT WAS REPORTED THAT USER WAS UNABLE TO STERILIZE/ASSEMBLE. IT WAS CHIPPING AND CRACKING. USER WAS UNABLE TO USE AND NEEDED REPLACEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22143776 ↗MalfunctionDec 9, 2024Material Deformation; Material Deformation
ADDITIONAL INFORMATION RECEIVED STATES THAT THE WIRE BENT IN MULTI GUIDE FROM PRESSURE SO WIRE DOESN¿T SLIDE SMOOTHLY ANYMORE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20883521 ↗MalfunctionNov 21, 2024Break; Break
ADDITIONAL INFORMATION RECEIVED STATES THAT THE GUIDE BROKE DURING PRE-OPERATIVE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20747433 ↗MalfunctionDec 19, 2023Break; Break
IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) , 2023, THE DRIVING CAP BROKE WHEN IMPACTING THE TIBIAL NAIL. THE FRAGMENT WAS LEFT IN THE JIG. ALSO THE INSERT HANDLE THREADED END HAD BROKEN OFF INTO THE AIM ARM. THE IMPACTOR AND JIG HAD BEEN CONNECTED PROPERLY. PROCEDURE WAS COMPLETED WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A RADIOLUCENT INSERTION HANDLE FOR EXPERT TIBIA NAILS/23MM THIS IS REPORT 1 OF 2 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18360584 ↗MalfunctionOct 11, 2023Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON SEPTEMBER 15, 2023, THE AIMING ARM WAS DAMAGED DURING REMOVAL. THE AIMING ARM WAS NOT LINING UP; THE SCREW WAS HITTING THE NAILS. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE RADIOLUCENT RECON AIMING ARM FOR EXPERT ALFN. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17911314 ↗MalfunctionJul 26, 2022Material Twisted/Bent; Material Twisted/Bent
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSTRUMENTS WERE FOUND TO HAVE WEAR AND TEAR. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) COMPRESSION DEVICE/ FOR TI CANNULATED TIBIA NAILS-EX. THIS IS REPORT 3 OF 4 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15102778 ↗MalfunctionJul 26, 2022Material Twisted/Bent; Material Twisted/Bent
DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSTRUMENTS WERE FOUND TO HAVE WEAR AND TEAR. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE (1) COMPRESSION DEVICE/ FOR TI CANNULATED TIBIA NAILS-EX. THIS IS REPORT 4 OF 4 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15102759 ↗
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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