Arthrex® AR-1934BCF-2-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888867097018), received between Oct 3, 2022 and Apr 8, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Break

  IT WAS REPORTED THAT DURING A MEDIAL PATELLOFEMORAL LIGAMENT (MPFL) SURGERY THE ANCHOR BROKE. NO PART REMAINED INSIDE 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 24820557 ↗
• MalfunctionMar 19, 2026Material Twisted/Bent

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY WHILE INSERTING THE IMPLANT THE PEEK IMPLANT BECAME BENT AND COULD THEREFORE NOT BE INSERTED. 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 24638075 ↗
• MalfunctionFeb 18, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE MEDIAL PATELLOFEMORAL LIGAMENT RECONSTRUCTION, THE ANCHOR FAILED TO HOLD AND WAS PULLED OUT. 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 24376081 ↗
• MalfunctionJan 15, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A SURGERY AFTER BROSTRÖM THE IMPLANT PULLED OUT AFTER INSERTING THE DEVICE INTO THE DRILL CHANNEL. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH JUST ONE DEVICE (IN THIS SURGERY THEY NORMALLY USE TWO DEVICES). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21157048 ↗
• MalfunctionMay 21, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-1934BCF-2-1 BIOCOMPOSITE SUTURETAK ANCHOR BROKE DURING INSERTION. ALL BROKEN FRAGMENTS WERE REMOVED. THE CASE WAS COMPLETED USING ANOTHER AR-1934BCF-2-1 BIOCOMPOSITE SUTURETAK. THIS WAS DISCOVERED DURING AN ANKLE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2024. THE CASE WAS DELAYED BETWEEN TEN TO FIFTEEN MINUTES; HOWEVER, ADDITIONAL ANESTHESIA WAS UNNECESSARY.

  Patient problems: Insufficient Information

  MAUDE report 19359299 ↗
• MalfunctionJan 5, 2024Material Fragmentation; Material Fragmentation

  ON 12/11/2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE THAT AN AR-1934BCF-2-1 BIOCOMPOSITE SUTURETAK ANCHOR BROKE DURING INSERTION. THE CASE WAS COMPLETED BY REMOVING ALL THE BROKEN FRAGMENTS AND USING ANOTHER AR-1934BCF-2-1 BIOCOMPOSITE SUTURETAK. THIS WAS DISCOVERED DURING A LIGAMENT TALUS REINFORCED FIXED SUTURE PROCEDURE ON (B)(6) 2023. THE PROCEDURE WAS DELAYED TWENTY MINUTES; HOWEVER, NO ADDITIONAL ANESTHESIA WAS NEEDED, AND THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18452510 ↗
• MalfunctionNov 28, 2022Break

  IT WAS REPORTED THAT DURING A BANKART AND SUPERIOR LABRUM ANTERIOR-TO-POSTERIOR (SLAP) REPAIR SURGERY THE THREADS OF THE ANCHORS AR-1934BCF-2-1 (LOT: 14894159) BROKE. ALL BROKEN PARTS WERE RETRIEVED FROM THE PATIENT. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15871191 ↗
• MalfunctionOct 3, 2022Break; Unstable

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY SURGERY DURING SCREWING IN, THE UPPER PART OF THE DEVICE BROKE AND THE THREADS BECAME UNSTABLE. THE DEVICE REMAINED IN THE PATIENT AND WAS USED TO FINISH THE PROCEDURE. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15534277 ↗