EliteRecalls & reported problems across all models
Synthes GmbH · 10 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 117
- Deaths reported
- 0
- Injuries reported
- 30
- Recalls
- 0
We found 10 models of Elite by Synthes GmbH in the FDA's device registry (GUDID). Together they are named in 117 adverse event reports in the FDA's MAUDE database, received between Dec 29, 2017 and Jan 15, 2026 — classified as 30 injuries, 87 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (41 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 Elite problems
Device problems
- Detachment of Device or Device Component41
- Break30
- Adverse Event Without Identified Device or Use Problem16
- Device-Device Incompatibility13
- Manufacturing, Packaging or Shipping Problem5
- Activation Problem4
- Migration3
- Mechanical Jam2
Patient problems
- No Clinical Signs, Symptoms or Conditions58
- No Consequences Or Impact To Patient20
- No Code Available7
- Pain7
- Discomfort6
- No Known Impact Or Consequence To Patient5
- Tissue Damage4
- Cellulitis3
Elite models
10 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Elite EL-1818S2Staple, Fixation, Bone48 reports
- Elite EL-1515S2Staple, Fixation, Bone24 reports
- Elite EL-DTSKit, Surgical Instrument, Disposable15 reports
- Elite EL-2520S4Staple, Fixation, Bone10 reports
- Elite EL-2020S2Staple, Fixation, Bone8 reports
- Elite EL-252007Y4Staple, Fixation, Bone4 reports
- Elite EL-1815S2Staple, fixation, bone3 reports
- Elite EL-3020S4Staple, Fixation, Bone2 reports
- Elite DK-300Kit, Surgical Instrument, Disposable2 reports
- Elite EL-251507Y4Staple, Fixation, Bone1 report
Recent Elite adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionJan 15, 2026Difficult to Advance
IT WAS REPORTED ON (B)(6) 2026, THAT THE BME STAPLE FAILED TO DEPLOY FROM INSERTION HANDLE. THE SURGEON DRILLED FOR THE STAPLE AND USED THE GUIDE. SHE INSERTED THE LEGS INTO HOLES, AND WHEN SHE WENT TO DEPLOY THE STAPLE, SHE COULD NOT GET THE STAPLE TO DISENGAGE FROM THE HANDLE. ANOTHER STAPLE WAS OPENED, AND THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS A FIVE (5) MINUTE DELAY IN THE SURGERY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24081202 ↗MalfunctionAug 4, 2025Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE STAPLES PRE DEPLOYED BEFORE PULLING / PUSHING BUTTON, SURGEON DID NOT WANT ANYTHING TO BE CHARGED. THE MULTIFUNCTION TOOL DID NOT THREAD, SD 2.5 HEX WAS WARPED (SD314.001).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22709842 ↗MalfunctionAug 4, 2025Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE STAPLES PRE DEPLOYED BEFORE PULLING / PUSHING BUTTON, SURGEON DID NOT WANT ANYTHING TO BE CHARGED. THE MULTIFUNCTION TOOL DID NOT THREAD, SD 2.5 HEX WAS WARPED (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22709761 ↗InjuryJul 28, 2025Break; Break
IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH THE BME ELITE WHICH BROKE AND CAUSED PAIN REQUIRING REMOVAL SURGERY. THE PATIENT ALSO HAD TWO SCREWS IMPLANTED, HOWEVER THERE IS NO REPORTED DEFICIENCY AT THIS TIME. THE INITIAL SURGERY WAS DONE TO REPAIR DAMAGE FROM GOUT AND ARTHRITIS.
Patient problems: Pain
MAUDE report 22637708 ↗MalfunctionApr 9, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE STAPLE PREMATURELY DEPLOYED. THERE WAS NO OPERATION INVOLVED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21806911 ↗MalfunctionMar 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE STAPLE CAME OUT OF THE BOX DISENGAGED FROM INSERTION HANDLE. SURGEON DECIDED TO USE A PLATE INSTEAD. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF UNKNOWN LENGTH.
Patient problems: Insufficient Information
MAUDE report 21631299 ↗MalfunctionMar 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE STAPLE CAME OUT OF THE BOX DISENGAGED FROM INSERTION HANDLE. SURGEON DECIDED TO USE A PLATE INSTEAD. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF UNKNOWN LENGTH.
Patient problems: Insufficient Information
MAUDE report 21631179 ↗MalfunctionMar 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT THE STAPLE CAME OUT OF THE BOX DISENGAGED FROM INSERTION HANDLE. SURGEON DECIDED TO USE A PLATE INSTEAD. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A SURGICAL DELAY OF UNKNOWN LENGTH.
Patient problems: Insufficient Information
MAUDE report 21631146 ↗MalfunctionMar 12, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2025, THE STAPLES DID NOT PROPERLY DISENGAGE FROM THE INSERTER, CAUSING THEM TO NOT BE ABLE TO BE INSERTED IN THE BONE. A NEW IMPLANT WAS OPENED. PROCEDURE SUCCESSFULLY COMPLETED WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21586823 ↗MalfunctionMar 12, 2025Device-Device Incompatibility; Device-Device Incompatibility
IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2025, THE STAPLES DID NOT PROPERLY DISENGAGE FROM THE INSERTER, CAUSING THEM TO NOT BE ABLE TO BE INSERTED IN THE BONE. A NEW IMPLANT WAS OPENED. PROCEDURE SUCCESSFULLY COMPLETED WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21586822 ↗MalfunctionNov 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED, THAT ON NOVEMBER 12, 2024. WHEN THE BME STAPLE WAS RELEASED FROM THE INSERTER, THE STAPLE WENT FLYING ON THE FLOOR. THE SURGEON USED A DIFFERENT STAPLE. THERE WAS NO SURGERY DELAYED, DUE TO THE REPORTED EVENT. THE PROCEDURE SUCCESSFULLY COMPLETED WITH NO FRAGMENTS GENERATED. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20773277 ↗MalfunctionNov 20, 2024Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING THE INSERTION OF A 20 X 20 ELITE STAPLE IN A LAPIS BUNIONECTOMY CASE, THE INSERTION HANDLE EXPLODED INTO MULTIPLE PIECES. THERE WAS A SURGICAL DELAY OF 10 MINUTES. THE PROCEDURE COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20736275 ↗MalfunctionNov 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2024, THE STAPLE CAME OFF OF INSERTER, NOT ALLOWING IT TO BE DEPLOYED IN THE PATIENT PROPERLY. THERE WAS NO SURGERY DELAYED DUE TO THE REPORTED EVENT. THERE WAS NO PATIENT CONSEQUENCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20666612 ↗MalfunctionNov 6, 2023Break; Break
IT WAS REPORTED THAT ON AN UNKNOWN DATE THE REAMER SHAFTS WERE BENT AT THE TIP AFTER REAMING. THE REAMER HEADS WOULD NOT SNAP ON. THE STAPLE WAS USED AND RELEASED EARLY. WHEN GENTLY MALLETTING THE STAPLE, AND DRILLING LINE TO LINE, THE 7.5 X 95 X 2 SCREWS HAD NO PURCHASE AND THE TIP SEEMED TO BREAK OFF DURING INSERTION. THERE WAS NO PREDRILL. STAPLE, AND SCREWS WERE NOT CHARGED TO PATIENT AND STILL IMPLANTED. THERE WERE 3 MINS OF SURGICAL DELAY. THERE WAS NO PATIENT OUTCOME. THIS REPORT INVOLVES ONE (1) ELITE 18X18X18MM, STRAIGHT BRIDGE, 2 LEGS. THIS IS REPORT 2 OF 3 FOR (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18074686 ↗InjuryJun 21, 2023Adverse 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 AN UNKNOWN PROCEDURE WITH THE PRODUCTS IN QUESTION. AFTER THE PROCEDURE THE PATIENT PRESENTED WITH A SUPERFICIAL CELLULITIS INFECTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN UNK - BONE STAPLE: ELITE. THIS IS REPORT 2 OF 3 FOR (B)(4).
Patient problems: Osteolysis
MAUDE report 17174327 ↗
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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