Elite EL-2020S2Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00810633021699), received between Aug 1, 2018 and Apr 9, 2025 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionApr 27, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE ON APRIL 13, 2023. THE IMPLANT WAS OPENED AND WAS PARTIALLY COMPRESSED AND WOULDN¿T INSERT. ANOTHER IMPLANT WAS OPENED AND SURGERY CONTINUED. PROCEDURE WAS COMPLETED WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A ELITE 20 X 20 X 20 MM (2 LEGS) STRAIGHT IMPLANT. THIS IS REPORT 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16827052 ↗
• InjurySep 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT A REMOVAL SURGERY OF THE 20/20 ELITE COMPRESSION IMPLANT DUE TO IMPLANT FAILURE AFTER A GYNECOLOGY PROCEDURE. WHEN THE PATIENT WAS MOVED INTO STIRRUPS, THE OPEN-BOOK PELVIC REDUCTION WAS LOST. THE INITIAL SURGERY WAS DONE ON (B)(6) 2021. THE REVISION SURGERY WAS COMPLETED WITH A 6.5 MM CANNULATED SCREW AND A 145 MM DRILL BIT. THE OUTCOME OF THE PROCEDURE WAS GOOD. THIS REPORT IS FOR AN ELITE COMPRESSION IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12413471 ↗
• MalfunctionDec 9, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2020,DURING AN UNKNOWN PROCEDURE, A DRILL BIT FOR BIOMEDICAL (BME) ELITE IMPLANT DRILL KIT WITH DRILL BIT WAS NOT SHARP ENOUGH ON OSCILLATING DRILL MODE AND JUMPING AROUND INTO THE BONE. AFTER THAT SURGEON USED THE DRILL BIT IN A FORWARD DRILL POSITION AND THE DRILL BIT DRILLED THE HOLE TO THE APPROPRIATE DEPTH. AFTER THAT SURGEON ATTEMPTED TO IMPLANT A BIOMEDICAL (BME) ELITE IMPLANT AND TRIED TO RELEASE THE STAPLE OR CCI FROM THE INSERTER, BUT HE COULD NOT RELEASE IT FROM THE INSERTER SO ANOTHER IMPLANT WAS OPENED AND INSERTED WITH NO ISSUES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A TWENTY TO THIRTY (20-30) SECONDS OF SURGICAL DELAY. THE PATIENT STATUS IS UNKNOWN.THIS REPORT IS FOR ONE (1) BME ELITE(TM) IMPLANT KIT 20 X 20 MM, 2 LEGS.THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10979734 ↗
• MalfunctionNov 26, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN USA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE ELITE COMPRESSION IMPLANT KIT STAPLE INSERTER DID NOT FULLY RELEASE THE STAPLE, PULLING THE STAPLE OUT OF THE BONE WHEN BEING REMOVED. IT IS UNKNOWN IF FRAGMENTS WERE GENERATED. NO SURGICAL DELAY. IT IS UNKNOWN IF THE PROCEDURE SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR 1 ELITE COMPRESSION IMPLANT KIT 20X20X20MM 2 LEGS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9375931 ↗
• MalfunctionMay 3, 2019Activation Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING A FOOT SURGERY THE ELITE COMPRESSION IMPLANT KIT DID NOT DEPLOY FROM THE INSERTER. THEY USED ANOTHER ONE TO COMPLETE THE PROCEDURE. IT WAS UNKNOWN IF THERE A SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN INSERTION INSTRUMENT (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY #: 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8579079 ↗
• MalfunctionAug 1, 2018Mechanical Jam; Mechanical Jam

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A TRIPLE FOOT ARTHRODESIS SURGERY PERFORMED ON (B)(6) 2018 THERE WERE SEVERAL ISSUES. TWO (2) OF THE DRILLING TEMPLATES FROM THE SAME PACKAGE BROKE DURING THE PROCEDURE. ALL THE FRAGMENTS OF THE BROKEN DRILLING TEMPLATES WERE REMOVED FROM THE PATIENT. THEN THERE WAS A DEFECT ON THE PACKAGING OF THE IMPLANT (IMPLANT WAS NOT HOLDING PROPERLY ON THE STERILE PART THAT THE NURSE TOOK ON THE TABLE. IT WAS "FALLING" IN THE STERILE PART OF THE PACKAGING THAT IS HOLD BY THE NON-STERILE PERSON). IT WAS ALSO REPORTED THAT IT WAS IMPOSSIBLE TO RELEASE THE IMPLANT FROM THE INSERTION TOOL. THERE WERE NO PATIENT CONSEQUENCES. THE FAULTY DEVICES WERE REPLACED DURING SURGERY AND NO DELAY WAS CAUSED. THE SURGERY WAS SUCCESSFUL. THIS REPORT IS FOR ONE (1) ELITE COMPRESSION IMPLANT KIT 20X20X20MM 2 LEGS. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7740609 ↗