Elite EL-1818S2Recalls & reported problems
Synthes GmbH · ELITE 18x18x18mm, Straight Bridge, 2 Legs · Class 2 · Implant
All models of Elite (10)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This Synthes ELITE bone staple is used to fix bone during surgery. The 48 reports mostly describe staples coming apart from the inserter or breaking during placement, along with pain and a superficial infection after surgery. Reports mention 17 injuries and no deaths, with 31 malfunctions. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 48
- Deaths reported
- 0
- Injuries reported
- 17
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 00810633021682), received between Apr 8, 2019 and Jul 28, 2025 — classified as 17 injuries, 31 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (21 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.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component21
- Adverse Event Without Identified Device or Use Problem9
- Device-Device Incompatibility9
- Break4
- Activation Problem2
- Migration2
- Device Difficult to Maintain1
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions27
- Pain7
- Discomfort6
- Tissue Damage4
- No Code Available3
- No Consequences Or Impact To Patient3
- Osteolysis3
- No Patient Involvement1
Recent adverse event reports
The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.
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 ↗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 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 ↗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 3 OF 3 FOR (B)(4).
Patient problems: Osteolysis
MAUDE report 17174286 ↗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 1 OF 3 FOR (B)(4).
Patient problems: Osteolysis
MAUDE report 17174247 ↗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 EXPLANTATION SURGERY FOR THE HARDWARE IN QUESTION. THE PATIENT HAD BEEN EXPERIENCING GENERAL PAIN/DISCOMFORT. 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: Discomfort; Pain
MAUDE report 17173818 ↗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 EXPLANTATION SURGERY FOR THE HARDWARE IN QUESTION. THE PATIENT HAD BEEN EXPERIENCING GENERAL PAIN/DISCOMFORT. 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: Discomfort; Pain
MAUDE report 17173809 ↗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 EXPLANTATION SURGERY FOR THE HARDWARE IN QUESTION. THE PATIENT HAD BEEN EXPERIENCING GENERAL PAIN/DISCOMFORT. 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: Discomfort; Pain
MAUDE report 17173804 ↗MalfunctionJun 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THE PROCEDURE AFFECTED WAS A JOINT ARTHRODESIS OF THE FOOT. ADDITIONALLY, A POSTOPERATIVE SUPERFICIAL INFECTION WAS TREATED WITH ANTIBIOTICS. THIS REPORT IS FOR A ELITE COMP IMPL KIT 18X18X18 2 LEGS. THIS REPORT IS RELATED TO (B)(4), WHICH CAPTURES THE REPORTED INFECTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17173342 ↗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. A REPLACEMENT STAPLE WAS OPENED. 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 17173339 ↗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. A REPLACEMENT STAPLE WAS OPENED. 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 17173332 ↗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 17173082 ↗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 17173081 ↗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 17173080 ↗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 EXPLANTATION SURGERY FOR THE HARDWARE IN QUESTION. THE PATIENT HAD BEEN EXPERIENCING GENERAL PAIN/DISCOMFORT. 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: Discomfort; Pain
MAUDE report 17172948 ↗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 EXPLANTATION SURGERY FOR THE HARDWARE IN QUESTION. THE PATIENT HAD BEEN EXPERIENCING GENERAL PAIN/DISCOMFORT. 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: Discomfort; Pain
MAUDE report 17172946 ↗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 EXPLANTATION SURGERY FOR THE HARDWARE IN QUESTION. THE PATIENT HAD BEEN EXPERIENCING GENERAL PAIN/DISCOMFORT. 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: Discomfort; Pain
MAUDE report 17172943 ↗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. A REPLACEMENT STAPLE WAS OPENED AND USED. 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 17172627 ↗MalfunctionJun 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THIS REPORT IS FOR ONE (1) ELITE COMP IMPL KIT 18X18X18 2 LEGS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17172619 ↗MalfunctionJun 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THIS REPORT IS FOR ONE (1) ELITE COMP IMPL KIT 18X18X18 2 LEGS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17172614 ↗MalfunctionJun 21, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
THIS REPORT IS FOR ONE (1) ELITE COMP IMPL KIT 18X18X18 2 LEGS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17172606 ↗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 17172598 ↗
Other Staple, Fixation, Bone devices
- N/A StandardSynthes GmbH · Staple, Fixation, Bone2 recalls16 reports
- GII QUICKANCHOR ETHIBOND 212034Medos International Sàrl · STAPLE, FIXATION, BONE98 reports
- GII QUICKANCHOR ORTHOCORD 222983Medos International Sàrl · STAPLE, FIXATION, BONE94 reports
- Speed SE-0910Synthes GmbH · Staple, Fixation, Bone1 recall24 reports
- Speed Shift SE-2020-10Synthes GmbH · Staple, Fixation, Bone1 recall10 reports
- Lapiplasty SpeedPlate SK50Treace Medical Concepts, Inc. · Staple, Fixation, Bone59 reports
- Speed SE-1512Synthes GmbH · Staple, Fixation, Bone1 recall6 reports
- LUPINE ORTHOCORD 210709Depuy Mitek, LLC · STAPLE, FIXATION, BONE56 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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