EXPert NailRecalls & reported problems across all models
Synthes GmbH · 151 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one EXPert Nail model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 350
- Deaths reported
- 0
- Injuries reported
- 254
- Recalls
- 1
We found 151 models of EXPert Nail by Synthes GmbH in the FDA's device registry (GUDID). Together they are named in 350 adverse event reports in the FDA's MAUDE database, received between Dec 12, 2016 and Sep 9, 2026 — classified as 254 injuries, 96 malfunctions.
The most frequently reported specific device problem is “Device-Device Incompatibility” (56 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
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
EXPert Nail recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Jan 24, 2024Class IIOpen, Classified
Products not sterilized, sterility cannot be confirmed
Z-1234-2024 · Root cause: Process control · Recall details · FDA record ↗
Most reported EXPert Nail problems
Device problems
- Adverse Event Without Identified Device or Use Problem206
- Device-Device Incompatibility56
- Break54
- No Apparent Adverse Event9
- Crack7
- Material Twisted/Bent7
- Migration5
- Entrapment of Device4
Patient problems
- Nonunion/Delayed-union Bone Fracture95
- No Code Available92
- Unspecified Infection50
- No Clinical Signs, Symptoms or Conditions48
- No Consequences Or Impact To Patient27
- Pain27
- Impaired Healing19
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available18
EXPert Nail models
151 models, 100 per page, most reported first. Each model has its own page with its reports, recalls and device details.
- EXPert Nail 04.008.378SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 recall0 reports
- EXPert Nail 03.010.486ORTHOPEDIC MANUAL SURGICAL INSTRUMENT37 reports
- EXPert Nail 03.010.487ORTHOPEDIC MANUAL SURGICAL INSTRUMENT8 reports
- EXPert Nail 04.004.449SNAIL, FIXATION, BONE8 reports
- EXPert Nail 04.004.549SNAIL, FIXATION, BONE8 reports
- EXPert Nail 04.013.000ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES8 reports
- EXPert Nail 04.004.001NAIL, FIXATION, BONE7 reports
- EXPert Nail 04.013.046ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES7 reports
- EXPert Nail 04.034.449SNAIL, FIXATION, BONE7 reports
- EXPert Nail 04.034.452SNAIL, FIXATION, BONE7 reports
- EXPert Nail 04.004.008NAIL, FIXATION, BONE6 reports
- EXPert Nail 04.004.452SNAIL, FIXATION, BONE6 reports
- EXPert Nail 04.004.000NAIL, FIXATION, BONE5 reports
- EXPert Nail 04.013.556SScrew, fixation, bone5 reports
- EXPert Nail 04.034.552SNAIL, FIXATION, BONE5 reports
- EXPert Nail 04.004.243SNAIL, FIXATION, BONE4 reports
- EXPert Nail 04.004.443SNAIL, FIXATION, BONE4 reports
- EXPert Nail 04.008.000SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES4 reports
- EXPert Nail 04.008.001SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES4 reports
- EXPert Nail 04.034.349SNAIL, FIXATION, BONE4 reports
- EXPert Nail 04.034.355SNAIL, FIXATION, BONE4 reports
- EXPert Nail 04.034.443SNAIL, FIXATION, BONE4 reports
- EXPert Nail 04.034.455SNAIL, FIXATION, BONE4 reports
- EXPert Nail 04.034.655SNAIL, FIXATION, BONE4 reports
- EXPert Nail 04.003.001Screw, fixation, bone3 reports
- EXPert Nail 04.003.002ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES3 reports
- EXPert Nail 04.004.346SNAIL, FIXATION, BONE3 reports
- EXPert Nail 04.004.455SNAIL, FIXATION, BONE3 reports
- EXPert Nail 04.004.546SNAIL, FIXATION, BONE3 reports
- EXPert Nail 04.004.555SNAIL, FIXATION, BONE3 reports
- EXPert Nail 04.008.016SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES3 reports
- EXPert Nail 04.013.045Screw, fixation, bone3 reports
- EXPert Nail 04.013.047ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES3 reports
- EXPert Nail 04.013.452SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES3 reports
- EXPert Nail 04.013.752SScrew, fixation, bone3 reports
- EXPert Nail 04.034.346SNAIL, FIXATION, BONE3 reports
- EXPert Nail 04.034.446SNAIL, FIXATION, BONE3 reports
- EXPert Nail 04.034.558SNAIL, FIXATION, BONE3 reports
- EXPert Nail 04.001.002NAIL, FIXATION, BONE2 reports
- EXPert Nail 04.001.428SNAIL, FIXATION, BONE2 reports
- EXPert Nail 04.003.000Screw, fixation, bone2 reports
- EXPert Nail 04.003.357SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- EXPert Nail 04.003.360SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- EXPert Nail 04.003.364SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- EXPert Nail 04.003.460SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- EXPert Nail 04.003.465SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- EXPert Nail 04.004.002SNAIL, FIXATION, BONE2 reports
- EXPert Nail 04.004.010NAIL, FIXATION, BONE2 reports
- EXPert Nail 04.004.249SNAIL, FIXATION, BONE2 reports
- EXPert Nail 04.004.343SNAIL, FIXATION, BONE2 reports
- EXPert Nail 04.004.352SNAIL, FIXATION, BONE2 reports
- EXPert Nail 04.004.355SNAIL, FIXATION, BONE2 reports
- EXPert Nail 04.004.458SNAIL, FIXATION, BONE2 reports
- EXPert Nail 04.004.652SNAIL, FIXATION, BONE2 reports
- EXPert Nail 04.008.000ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- EXPert Nail 04.008.078SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- EXPert Nail 04.008.216SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- EXPert Nail 04.008.266SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- EXPert Nail 04.013.344SScrew, fixation, bone2 reports
- EXPert Nail 04.013.552SScrew, fixation, bone2 reports
- EXPert Nail 04.013.656SScrew, fixation, bone2 reports
- EXPert Nail 04.013.660SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- EXPert Nail 04.013.756SScrew, fixation, bone2 reports
- EXPert Nail 04.013.764SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- EXPert Nail 04.013.864SScrew, fixation, bone2 reports
- EXPert Nail 04.013.956SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- EXPert Nail 04.031.938SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES2 reports
- EXPert Nail 04.034.234SNAIL, FIXATION, BONE2 reports
- EXPert Nail 04.034.249SNAIL, FIXATION, BONE2 reports
- EXPert Nail 04.034.352SNAIL, FIXATION, BONE2 reports
- EXPert Nail 04.034.458SNAIL, FIXATION, BONE2 reports
- EXPert Nail 04.034.555SNAIL, FIXATION, BONE2 reports
- EXPert Nail 04.034.649SNAIL, FIXATION, BONE2 reports
- EXPert Nail 04.001.000NAIL, FIXATION, BONE1 report
- EXPert Nail 04.001.224SNAIL, FIXATION, BONE1 report
- EXPert Nail 04.001.234SNAIL, FIXATION, BONE1 report
- EXPert Nail 04.001.236SNAIL, FIXATION, BONE1 report
- EXPert Nail 04.001.410SNAIL, FIXATION, BONE1 report
- EXPert Nail 04.001.440SNAIL, FIXATION, BONE1 report
- EXPert Nail 04.003.003ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- EXPert Nail 04.003.252SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- EXPert Nail 04.003.257SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- EXPert Nail 04.003.348SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- EXPert Nail 04.003.352SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- EXPert Nail 04.003.353SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- EXPert Nail 04.003.356SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- EXPert Nail 04.003.456SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- EXPert Nail 04.003.461SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- EXPert Nail 04.003.464SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- EXPert Nail 04.003.469SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- EXPert Nail 04.003.561SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- EXPert Nail 04.003.565SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- EXPert Nail 04.003.664SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- EXPert Nail 04.003.752SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- EXPert Nail 04.003.860SROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES1 report
- EXPert Nail 04.004.000SNAIL, FIXATION, BONE1 report
- EXPert Nail 04.004.003NAIL, FIXATION, BONE1 report
- EXPert Nail 04.004.009NAIL, FIXATION, BONE1 report
- EXPert Nail 04.004.009SNAIL, FIXATION, BONE1 report
- EXPert Nail 04.004.252SNAIL, FIXATION, BONE1 report
Recent EXPert Nail adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 9, 2026Break; Crack; Device-Device Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50697325 ↗MalfunctionJan 28, 2026Break; Crack; Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE IT WAS IDENTIFIED THAT THE DEVICE IS UNABLE TO STERILIZE/ASSEMBLE. IT IS CHIPPING AND CRACKING AND UNABLE TO BE USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24202327 ↗MalfunctionJan 28, 2026Break; Crack; Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE IT WAS IDENTIFIED THAT THE DEVICE IS UNABLE TO STERILIZE/ASSEMBLE. IT IS CHIPPING AND CRACKING AND UNABLE TO BE USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24202325 ↗MalfunctionJan 28, 2026Break; Crack; Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE IT WAS IDENTIFIED THAT THE DEVICE IS UNABLE TO STERILIZE/ASSEMBLE. IT IS CHIPPING AND CRACKING AND UNABLE TO BE USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24202320 ↗MalfunctionJan 28, 2026Break; Crack; Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE IT WAS IDENTIFIED THAT THE DEVICE IS UNABLE TO STERILIZE/ASSEMBLE. IT IS CHIPPING AND CRACKING AND UNABLE TO BE USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24202318 ↗MalfunctionJan 28, 2026Break; Crack; Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE IT WAS IDENTIFIED THAT THE DEVICE IS UNABLE TO STERILIZE/ASSEMBLE. IT IS CHIPPING AND CRACKING AND UNABLE TO BE USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24202317 ↗MalfunctionJan 28, 2026Break; Crack; Device-Device Incompatibility
IT WAS REPORTED THAT ON AN UNKNOWN DATE IT WAS IDENTIFIED THAT THE DEVICE IS UNABLE TO STERILIZE/ASSEMBLE. IT IS CHIPPING AND CRACKING AND UNABLE TO BE USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24202315 ↗MalfunctionAug 28, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED THE IMPLANT BOX WAS LABELLED ACCORDING TO THE INTENDED SPECIFICATION, AND THE STERILE PACKAGING WAS INTACT AND PROPERLY SEALED. HOWEVER, UPON OPENING, THE CONTENTS DID NOT MATCH THE PRODUCT LABEL, RESULTING IN AN INCORRECT IMPLANT BEING SUPPLIED. THIS FORCED THE SURGEON TO USE A LONGER NAIL THAN INTENDED. NO SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22912613 ↗MalfunctionJul 15, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT ON (B)(6) 2025, THE INSTRUMENT NEEDED TO BE REPLACED, IT DOES NOT FIT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22506076 ↗InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT HARDWARE REMOVAL OF NAIL, FOUR SCREWS, AND END CAP. IT WAS A STAGE 2 PROCEDURE FOR NON-UNION. NO FRAGMENTS WERE RETAINED.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 21952817 ↗InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT HARDWARE REMOVAL OF NAIL, FOUR SCREWS, AND END CAP. IT WAS A STAGE 2 PROCEDURE FOR NON-UNION. NO FRAGMENTS WERE RETAINED.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 21952804 ↗InjuryJan 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2025, HARDWARE REMOVAL DUE TO NON-UNION, REVISION NAILING. LATERALITY = RIGHT, BONE = TIBIA, PROCEDURE = HWR TIBIA NAIL, DIAGNOSIS = NON-UNION.
Patient problems: Nonunion/Delayed-union Bone Fracture
MAUDE report 21182127 ↗MalfunctionSep 12, 2024Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT THIS IS A NEW EVENT WHICH HAPPENED YESTERDAY AT HOSPITAL. PART: 03.010.486. THE IMPACTOR SNAPPED OFF AND STUCK AT THE INSERTION HANDLE.
Patient problems: Insufficient Information
MAUDE report 20202153 ↗MalfunctionSep 3, 2024Break; Break
ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY REPORTED AND THERE WAS NO FRAGMENTS GENERATED.
Patient problems: Insufficient Information
MAUDE report 20127169 ↗InjuryAug 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT PATIENT UNDERWENT REVISION SURGERY OF AN EXPERT TIBIAL NAIL ON (B)(6) 2024, AFTER THE FRACTURE HAD HEALED. THE PATIENT RECENTLY SUFFERED AN ACL RE-RUPTURE. AT THE SAME TIME, RELEVANT LATERAL ARTHROSIS WAS DIAGNOSED. THERE WAS NO INFECTION IDENTIFIED. THE NAIL WAS NOT ABLE TO BE REMOVED. PROCEDURE WAS COMPLETED WITH AN UNKNOWN DELAY. THIS REPORT IS FOR A 9MM TI CANNULATED TIBIAL NAIL-EX/330MM-STERILE. THIS IS REPORT 1 OF 1 FOR (B)(4).
Patient problems: Unspecified Tissue Injury
MAUDE report 19964305 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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