Arthrex® AR-1926BC-1Recalls & reported problems
Arthrex, Inc. · SUTURE ANCHOR, BIO- COMPOSITE PUSHLOCK · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00888867023246), received between Dec 21, 2021 and Mar 31, 2026 — classified as 11 malfunctions.
The most frequently reported specific device problem is “Break” (10 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
- Break10
- Material Twisted/Bent1
Patient problems
- No Clinical Signs, Symptoms or Conditions9
- Foreign Body In Patient2
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 31, 2026Break
IT WAS REPORTED THAT DURING THE ROTATOR CUFF REPAIR, THE TIP OF THE IMPLANT GOT DAMAGED DURING INSERTION. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24742122 ↗MalfunctionFeb 13, 2026Break
IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY THE PLASTIC TIP BROKE DURING IMPLANT INSERTION. ALL BROKEN PARTS WERE RETRIEVED FROM THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24337501 ↗MalfunctionAug 29, 2025Break; Break
IT WAS REPORTED DURING THE KNEE ARTHROSCOPY THAT THE ANCHOR BROKE. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22921108 ↗MalfunctionAug 27, 2025Break; Break
IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY THE EYELET BROKE DURING IMPLANTATION. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22902973 ↗MalfunctionMar 7, 2025Break; Break
IT WAS REPORTED THAT DURING A TROCHLEOPLASTY THE TIP OF THE DEVICE BROKE AT THE THREAD. ALL BROKEN PIECES WERE RETRIEVED OUT OF THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21549537 ↗MalfunctionDec 6, 2024Break; Break
IT WAS REPORTED THAT DURING A LABRUM SURGERY THE ANCHOR BROKE INSIDE THE PATIENT. ALL BROKEN OFF PARTS HAVE BEEN RETRIEVED FROM THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20869671 ↗MalfunctionJul 22, 2024Break; Break
IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR SURGERY THE IMPLANT BROKE WHILE BEING SCREWED INTO A PRE-DRILLED HOLE. IT CAUSED THE SUTURE BREAKAGE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19793960 ↗MalfunctionMay 3, 2024Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT DURING A LABRUM-REFIX SURGERY THE TIP OF THE ANCHOR BECAME BENT AND COULD NOT BE INSERTED. 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.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19239590 ↗MalfunctionNov 6, 2023Break; Break
IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE ANCHOR BROKE WHILE INSERTING INTO THE PREPARED CHANNEL. IT WAS ONLY POSSIBLE TO RETRIEVE THE BROKEN PARTS PARTIALLY. 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.
Patient problems: Foreign Body In Patient
MAUDE report 18073385 ↗MalfunctionNov 6, 2023Break; Break
IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE ANCHOR BROKE WHILE INSERTING INTO THE PREPARED CHANNEL. IT WAS ONLY POSSIBLE TO RETRIEVE THE BROKEN PARTS PARTIALLY. 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.
Patient problems: Foreign Body In Patient
MAUDE report 18073186 ↗MalfunctionDec 21, 2021Break
IT WAS REPORTED THAT DURING A STABILIZATION SURGERY THE DEVICE BROKE DURING IMPLANTATION. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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. UPDATE AVOE 07-DEZ-2021: IT WAS CONFIRMED THAT THE INTERFERENCE SCREW OF THE DEVICE BROKE DURING IMPLANTATION OF THE DEVICE AND ALL FRAGMENTS WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13054598 ↗
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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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