Elite EL-2520S4Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00810633021705), received between Feb 7, 2018 and Feb 23, 2022 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 18, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 23, 2022Device Slipped; Migration; Device Slipped; Migration

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHEN THE RESIDENT WAS ABOUT TO PUT THE ELITE IMPLANT KIT STAPLE INTO THE BONE HE NOTICED IT WAS LOOSE AND PARTIALLY DEPLOYED. WHEN THE RESIDENT PUT THE STAPLE ONTO THE BONE IT DEPLOYED BEFORE HE COULD EVEN INSERT IT. ANOTHER STAPLE WAS OPENED TO FINISH THE CASE. THERE WERE THREE MINUTES SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT INVOLVES ONE (1) ELITE 25X20X20MM, STRAIGHT BRIDGE, 4 LEGS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13586430 ↗
• MalfunctionFeb 11, 2022Activation Problem; Activation Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING AN UNKNOWN PROCEDURE, THERE WAS A MALFUNCTION WITH TWO (2) BME ELITE CONTINUOUS COMPRESSION IMPLANTS. THE CLIP DID NOT RELEASE WHEN THE STAPLE WENT INTO THE BONE. THERE WAS NO PATIENT IMPACT, JUST TIME LOSS, NO ISSUE OR INJURY TO PATIENT. THIS REPORT IS FOR ONE (1) ELTE COMP IMPL KIT 25X20X20X20X20 4 LEGS THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13517934 ↗
• MalfunctionJun 4, 2021Break; Material Deformation; Break; Material Deformation

  THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11938057 ↗
• MalfunctionApr 15, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED 1.1MM DRILL BIT BROKE DURING THE PROCEDURE ON MARCH 19, 2021. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 1.1MM DRILL BIT/MINI QC WITH 12MM STOP/44.5MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11675099 ↗
• MalfunctionJan 13, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT FOR AN UNKNOWN PROCEDURE. DURING THE PROCEDURE, THE DRILL SPLIT. IT WAS UNKNOWN IF THE PROCEDURE COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 1.1MM DRILL BIT/MINI QC WITH 12MM STOP/44.5MM. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11166924 ↗
• MalfunctionNov 12, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN OPEN REDUCTION AND FIXATION OF ORBITAL RIM FRACTURE PROCEDURE, THE DRILL BIT TIP BROKE WHILE THE DRILL WAS BEING USED TO DRILL A HOLE IN THE FRONTAL BONE. A FRAGMENT WAS GENERATED AND EASILY REMOVED FROM THE PATIENT. THERE WAS NO PATIENT CONSEQUENCE. THE PROCEDURE WAS COMPLETED WITH THE USE OF A SHORTER LENGTH DRILL BIT. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) 1.1MM DRILL BIT/MINI QC WITH 12MM STOP/44.5MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10830290 ↗
• MalfunctionOct 6, 2020Break; Break

  UPDATED EVENT DESCRIPTION: THE AFOREMENTIONED FRAGMENT OF THE SCREW THAT HAD BEEN LEFT REFERS TO THE PART OF AN IMPLANT. THIS IS AN INITIAL PROCEDURE. THIS COMPLAINT INVOLVES THREE (3) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10638057 ↗
• MalfunctionAug 3, 2020Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE, TWO DRILL BITS BROKE. A 1.1.MM DRILL BIT WITH 8MM STOP BROKE AND A BROKEN PART REMAINED IN THE PATIENT. A 1.1MM DRILL BIT WITH 12MM STOP BROKE AND THE BROKEN PARTS WERE EASILY REMOVED. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER DRILL BIT. THIS REPORT IS FOR ONE (1) 1.1MM DRILL BIT/MINI QC WITH 12MM STOP/44.5MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10357344 ↗
• InjuryJul 3, 2019Break; Break

  IT WAS REPORTED THAT ON JUNE 06, 2019, TWO (2) LEGS OF THE ELITE COMPRESSION IMPLANT KIT FOUR LEGGED STAPLE HAD BROKEN POSTOPERATIVELY AND IDENTIFIED BY X-RAY. THE OTHER BROKEN HARDWARE WAS FROM ANOTHER MANUFACTURER. THERE IS NO SCHEDULED REVISION YET. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT AND SURGICAL OUTCOME ARE UNKNOWN. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8759615 ↗
• InjuryFeb 7, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN ORTHOPAEDIC PROCEDURE ON (B)(6) 2018 WHILE DRILLING IN THE BONE, THE DRILL BIT BROKE. THE TIP OF THE DRILL BIT REMAINS IN THE PATIENT'S BONE. THERE IS NO REPORT OF PATIENT HARM OR SURGICAL DELAY. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 7249221 ↗