Elite EL-DTSRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00810633021965), received between Dec 29, 2017 and Mar 18, 2025 — classified as 3 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Break” (14 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• 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 6, 2019Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE, THE ELITE COMPRESSION IMPLANT DRILLING TEMPLATE WAS BROKEN. THERE WAS A LITTLE BIT OF SURGICAL DELAY IMPLANTING THE IMPLANT BECAUSE IT DID NOT DRILL AS DESIRED AND IT WAS BROKEN. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR AN ELITE DRILL KIT - S SHAPED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8394150 ↗
• MalfunctionFeb 1, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, A DRILL BIT BROKE DURING AN UNKNOWN PROCEDURE. ANOTHER DRILL BIT WAS OPENED. THERE WAS NO SURGICAL DELAY. PROCEDURE OUTCOME WAS SUCCESSFUL. PATIENT STATUS WAS STABLE. THIS REPORT IS FOR ONE (1) ELITE COMPRESSION IMPLANT DRILLING TEMPLATES. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8297705 ↗
• MalfunctionJan 24, 2019Break; Break

  IT WAS FURTHER REPORTED THAT NO FRAGMENTS REMAINED IN THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8274057 ↗
• InjuryJan 15, 2019Break; Break

  SURGEON STATED THAT THEY ARE USED TO HAVING SCREWS BOUNCE OFF AND AROUND EACH OTHER; IT CAN¿T BE DONE WITH STAPLES.

  Patient problems: No Code Available

  MAUDE report 8250674 ↗
• MalfunctionDec 31, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, DURING THE MIDFOOT FUSION PROCEDURE, ONE OF THE ELITE COMPRESSION IMPLANT DRILLING TEMPLATES IN THE SET BROKE IN THE MIDDLE OF THE PROCEDURE. THE SURGEON WAS ABLE TO USE AN ALTERNATIVE, THE SECOND ELITE COMPRESSION IMPLANT DRILLING TEMPLATES IN THE SET. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE EVENT DID NOT AFFECT THE PATIENT. THIS REPORT IS FOR ONE (1) ELITE COMPRESSION IMPLANT DRILLING TEMPLATES. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8205703 ↗
• MalfunctionNov 20, 2018Break; Break

  IT WAS REPORTED THAT DURING A LAPIDUS PROCEDURE ON (B)(6) 2018, THE PLASTIC DRILL GUIDE BROKE WHILE THE SURGEON WAS ATTEMPTING TO DRILL HOLES FOR A STAPLE. THERE WAS A SURGICAL DELAY OF TWO (2) MINUTES. THE SURGERY WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) ELITE COMPRESSION IMPLANT DRILLING TEMPLATES. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8090927 ↗
• MalfunctionAug 1, 2018Break; Break

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

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7740579 ↗
• MalfunctionAug 1, 2018Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A TALONAVICULAR REVISION SURGERY ON (B)(6) 2018, TO REMOVE TWO (2) NON-SYNTHES SCREWS. THE SURGEON USED THE ELITE COMPRESSION IMPLANT DRILLING TEMPLATES TO REVISE THE PATIENT TO STAPLES. THE SURGEON DRILLED ONE PART AND PLACED A STAPLE ON THE MEDIAL SIDE SUCCESSFULLY. THE SURGEON DRILLED AND PLACED ANOTHER STAPLE ON THE DORSAL SIDE. THE SURGEON WAS NOT SATISFIED WITH THE PLACEMENT OF THE STAPLE ON THE DORSAL SIDE AND REMOVED THE STAPLE. THE ELITE COMPRESSION IMPLANT DRILLING TEMPLATE WAS USED TO DRILL ANOTHER PART WHEN IT TWISTED AND BROKE. THE BROKEN PIECES WERE RETRIEVED AND DID NOT ENTER THE PATIENT. THE SURGEON WAS ABLE TO SUCCESSFULLY IMPLANT A WIDER STAPLE ON THE DORSAL SIDE. A NON-SYNTHES SCREW AND VIVIGEN WERE ADDED. ROUTINE INTRAOPERATIVE X-RAYS WERE TAKEN. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH A TWO MINUTE SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE: ELITE 30X20X20X20X20MM (4 LEGS) STRAIGHT IMPLANT (PART: EL-3020S4, LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR AN ELITE DRILL KIT - S SHAPED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7740071 ↗
• MalfunctionJul 11, 2018Break; Break

  IT WAS REPORTED THAT DURING A FOOT SURGERY PROCEDURE ON (B)(6) 2018, THE 25MM DRILL GUIDE FROM ELITE COMPRESSION IMPLANT DRILLING TEMPLATES (EL-DTS) BROKE DURING DRILLING. IT WAS NOTED THAT THE BROKEN PIECES WERE RECOVERED AND NEW DRILL KIT WAS USED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. IT WAS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME WAS UNKNOWN. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7679306 ↗
• MalfunctionApr 25, 2018Break; Break

  IT WAS REPORTED THAT DURING A FOOT FUSION PROCEDURE ON (B)(6) 2018, ONE (1) ELITE COMPRESSION IMPLANT DRILLING TEMPLATE BROKE INTO FRAGMENTS. ANOTHER DRILLING TEMPLATE WAS AVAILABLE AT THE TIME AND WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY WITH NO DELAY. ALL FRAGMENTS WERE REPORTED TO HAVE BEEN REMOVED. THE PATIENT WAS REPORTED IN STABLE CONDITION AFTER THE PROCEDURE. CONCOMITANT DEVICES REPORTED: ELITE COMPRESSION IMPLANT DRILL KIT WITH 3.0 MM DRILL BIT (PART DK-300, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) ELITE COMPRESSION IMPLANT DRILLING TEMPLATE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7462517 ↗
• InjuryApr 4, 2018Break; Break

  IT WAS REPORTED THAT THE 20MM DRILL GUIDE FOR THE 2-LEG ELITE STAPLE SIZING GUIDES BROKE WHEN THE DOCTOR PUT THE DRILL BIT INTO IT DURING A PROCEDURE ON (B)(6) 2018. THIS WAS THE 4TH USE OF THE GUIDE DURING THE SURGERY. THE DOCTOR DID NOT DRILL THROUGH THE 20MM GUIDE AFTER IT BROKE. HE SWITCHED TO AN 18MM GUIDE AND USED AND 18X18 ELITE STAPLE. THERE WAS NO DELAY IN SURGERY TIME AND NO PATIENT ISSUES. THERE IS NO ADDITIONAL INFORMATION. CONCOMITANT DEVICE(S): DRILL BIT (PART #: UNKNOWN, LOT #: UNKNOWN, QTY: 1). THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7397109 ↗
• MalfunctionJan 16, 2018Break; Break

  CONCOMITANT DEVICES REPORTED: 3.0 MM DRILL BIT ELITE DRILL KIT (PART# DK-300, LOT# BDK170687, QUANTITY# 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7195877 ↗
• MalfunctionJan 12, 2018Break; Break

  IT WAS REPORTED THAT THE DRILL GUIDE FOR A BME STAPLE IMPLANT BROKE INTO TWO (2) PIECES DURING A MIDFOOT FUSION ON (B)(6) 2017. THE SURGEON CONTINUED TO USE THE DRILL GUIDE TO COMPLETE THE PROCEDURE. THE FRAGMENTS WERE EASILY RETRIEVED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH GOOD PATIENT OUTCOME. CONCOMITANT DEVICE REPORTED: ELITE COMPRESSION IMPLANT KIT 18X18X18MM 2 LEGS (PART EL-1818S2, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) ELITE COMPRESSION IMPLANT DRILLING TEMPLATE (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7186079 ↗
• InjuryDec 29, 2017Break; Break

  IT WAS REPORTED THAT A DRILL GUIDE FOR THE 25MM ELITE 4 LEG STAPLE BROKE WHILE DRILLING INTO THE BONE. THE SURGERY WAS COMPLETED BY USING A SCREW TO FUSE THE JOINT. NO FURTHER INFORMATION IS AVAILABLE. (B)(4).

  Patient problems: No Code Available

  MAUDE report 7154952 ↗