Elite EL-1515S2Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00810633021675), received between May 15, 2018 and Jan 15, 2026 — classified as 7 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (13 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 24 most recent of 24 reports, 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 ↗
• 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 ↗
• 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 STAPLE FELL OFF OF THE INSERTER. HOWEVER, THE STAPLE WAS STILL ABLE TO BE USED. 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 3 OF 3 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 17172603 ↗
• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS FURTHER REPORTED THAT THE STAPLES FELL OFF PRIOR TO IMPLANT. THIS REPORT IS FOR ONE (1) ELITE COMP IMPL KIT 15X15X15 2 LEGS.

  Patient problems: Unspecified Infection

  MAUDE report 17172602 ↗
• 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 STAPLE FELL OFF OF THE INSERTER. HOWEVER, THE STAPLE WAS STILL ABLE TO BE USED. 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: Unspecified Infection

  MAUDE report 17172601 ↗
• 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 STAPLE FELL OFF OF THE INSERTER. HOWEVER, THE STAPLE WAS STILL ABLE TO BE USED. 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: Cellulitis

  MAUDE report 17172584 ↗
• 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 STAPLE FELL OFF OF THE INSERTER. HOWEVER, THE STAPLE WAS STILL ABLE TO BE USED. 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 3 OF 3 FOR (B)(4).

  Patient problems: Cellulitis

  MAUDE report 17172583 ↗
• 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 STAPLE FELL OFF OF THE INSERTER. HOWEVER, THE STAPLE WAS STILL ABLE TO BE USED. 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 1 OF 3 FOR (B)(4).

  Patient problems: Cellulitis

  MAUDE report 17172581 ↗
• MalfunctionJun 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE STAPLE FELL OFF OF THE INSERTER. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN UNK - BONE STAPLE: ELITE. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17172572 ↗
• MalfunctionJun 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE STAPLES FELL OFF PRIOR TO IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17172571 ↗
• MalfunctionJun 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE STAPLE FELL OFF OF THE INSERTER. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17172570 ↗
• MalfunctionJun 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE STAPLE FELL OFF OF THE INSERTER. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN UNK - BONE STAPLE: ELITE. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17172567 ↗
• MalfunctionJun 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE STAPLE FELL OFF OF THE INSERTER. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17172563 ↗
• MalfunctionJun 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE STAPLE FELL OFF OF THE INSERTER. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN UNK - BONE STAPLE: ELITE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17172560 ↗
• MalfunctionJun 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE STAPLE FELL OFF OF THE INSERTER. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN UNK - BONE STAPLE: ELITE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17172559 ↗
• MalfunctionJun 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE STAPLE FELL OFF OF THE INSERTER. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN UNK - BONE STAPLE: ELITE. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17172558 ↗
• MalfunctionApr 4, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT (B)(6) 2023 PATIENT WAS HAVING A TMT FUSION. SURGEON APPROPRIATELY PREPARED SITE FOR INSERTION OF CCI. WHEN THE SURGEON WENT TO PLACE THE CCI INTO THE BONE, THE CCI ABRUPTLY DISENGAGED FROM THE INSERTION HANDLE WHEN THE LEGS WERE ABOUT 2MM INSIDE BONE. A NEW CCI WAS OPENED. THERE WAS 5 MINS OF DELAY IN SURGERY. SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) ELITE COMP IMPL KIT 15X15X15 2 LEGS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16674061 ↗
• MalfunctionNov 17, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CHILE AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, AT THE TIME OF PLACING THE IMPLANT IN THE PATIENT, BEFORE FINISHING PLACING IT, THE IMPLANT CAME LOOSE FROM ITS HANDLE, SO IT COULD NOT BE PLACED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE ELITE 15X15X15MM, STRAIGHT BRIDGE, 2 LEGS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15818451 ↗
• MalfunctionJun 10, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2022, THE HAMMERTOE CCI IMPLANT WAS DISENGAGED FROM THE INSERTER WHEN THE STERILE PACKAGE WAS OPENED. THERE WAS A SURGICAL DELAY OF FIVE (5) MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE (1) ELITE 15X15X15MM, STRAIGHT BRIDGE, 2 LEGS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14653917 ↗
• InjuryApr 4, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT WAS OPERATED ON (B)(6) 2021. THEY HAD A WRIGHT MEDICAL WEDGE AND A SYNTHES CCI STAPLE 15 MM PLACED FOR A LATERAL LENGTHENING OR EVANS OSTEOTOMY. THE PATIENT APPEARED TO NOT HEAL AND BROKE THE CCI. THEY REVISED THE NON UNION SITE WITH PLIAFX, AND NEW 4 LEG CCI. PART NUMBERS INVOLVED IN THE DEFINITIVE SURGERY. SURGERY WAS COMPLETED SUCCESSFULLY. NO FRAGMENTS LEFT IN PATIENT. I MIGHT HAVE THE BROKEN PART FOR RETURN I¿M CHECKING. THIS COMPLAINT INVOLVES ONE(1) DEVICE ELITE COMP IMPL KIT 15X15X15 2 LEGS.

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 13995008 ↗
• MalfunctionNov 17, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A TARSO METATARSAL SECOND DIGIT FUSION PROCEDURE, AN ELITE COMPRESSION IMPLANT WAS DEPLOYED BEFORE IMPLANTING. SURGEON TRIED TO REINSTALL THE ELITE COMPRESSION IMPLANT TO THE HOLDER BUT WILL NOT WORK. TRIED TO IMPLANT ELITE COMPRESSION IMPLANT WITHOUT THE HOLDER, BUT ENDED UP DISTRACTING THE FUSION SITE. ELITE COMPRESSION IMPLANT REMOVED. USED 3.0 MM CANNULATED SCREWS TO FINISH THE PROCEDURE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY REPORTED. NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) ELITE COMP IMPL KIT 15X15X15 2 LEGS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12833092 ↗
• MalfunctionSep 6, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE. IT WAS MENTIONED THAT THE BIOMEDICAL ENTERPRISE (BME) ELITE COMPRESSION IMPLANT WAS MISFIRED AND A NEW ONE HAD TO BE USED. THE CASE WENT FINE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A THREE (3) MINUTES SURGICAL DELAY. THE PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) ELITE COMPRESSION IMPLANT KIT 15 X 15 X 15 MM 2 LEGS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8969986 ↗
• MalfunctionAug 24, 2018Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT THE INSERTER WAS STUCK WHILE INSERTING A BME ELITE IMPLANT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2018. IT WILL NOT RELEASE, SO THE STAPLE CAME OUT AND COULD NOT BE IMPLANTED DUE TO THE ISSUE WITH THE INSERTER. THERE WAS A FIVE (5) MINUTE SURGICAL DELAY AND PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS GOOD. THIS REPORT IS FOR ONE (1) ELITE COMPRESSION IMPLANT KIT 15X15X15MM 2 LEGS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7814925 ↗
• MalfunctionMay 15, 2018Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE SURGEON WAS ATTEMPTING TO IMPLANT ONE OF THE BME ELITE STAPLES IN PROXIMAL TIBIA WHEN THE STAPLE WOULD NOT RELEASE FROM THE HANDLE (THE RELEASE TRIGGER WOULD NOT MOVE). THE SURGEON WAS PULLING WITH TWO HANDS TO RELEASE THE TRIGGER AND IT WOULD NOT RELEASE. THE SALES CONSULTANT OPENED A SECOND IMPLANT AND IT WORKED PERFECTLY. THE SURGERY CONTINUED WITHOUT INCIDENT AND THERE WAS NOT PATIENT CONSEQUENCE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7514889 ↗