Arthrex® AR-8719MX-1818Recalls & reported problems
Arthrex, Inc. · SuperMX Compression Staple, 18W x 18L · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867300941), received between Jun 28, 2021 and Dec 1, 2023 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (2 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.
Reports received per month
Most reported problems
Device problems
- Break2
- Fracture1
Patient problems
- Insufficient Information2
- Failure of Implant1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 1, 2023Break; Break
IT WAS REPORTED THAT TWO STAPLES BROKE 6 WEEKS POSTOPERATIVELY AFTER A TN ARTHRODESE WHILST DECOMPRESSION WITH A HEEL SHOE. NO FURTHER INFORMATION RECEIVED.
Patient problems: Insufficient Information
MAUDE report 18246874 ↗MalfunctionDec 7, 2022Fracture
IT WAS REPORTED THAT A DYNANITE MX DEVICE BROKE INSIDE THE PATIENT AFTER THE IMPLANTATION. THE DEVICE WAS IMPLANTED 6 MONTHS AGO AND THEN HAD TO BE EXPLANTED DURING A REVISION SURGERY DUE TO THE FRACTURE OF THE COMPRESSION CLAMP. NO FURTHER INFORMATION RECEIVED.
Patient problems: Failure of Implant
MAUDE report 15931169 ↗MalfunctionJun 28, 2021Break
IT WAS REPORTED THAT DURING ARTHROSCOPY SURGERY THE CLIP DID BREAK OFF INTRAOPERATIVE. THE BROKEN OFF PIECE HAS BEEN RETRIEVED FROM THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. NO FURTHER INFORMATION RECEIVED.
Patient problems: Insufficient Information
MAUDE report 12076060 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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