Arthrex® AR-1934PF-24Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867024120), received between Jan 30, 2019 and Dec 10, 2025 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 11/21/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT FIVE AR-1934PF-24 PEEK SUTURETAK SUTURE ANCHORS PULLED OUT IN A SURGICAL CASE. THIS INCIDENT OCCURRED DURING A PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON 11/25/2025: THIS OCCURRED ON (B)(6) 2025, DURING A ROTATOR CUFF REPAIR WITH BICEPS TENODESIS PROCEDURE. THE CASE WAS COMPLETED USING AN AR-3632SP 2.6 FIBERTAK SP SOFT ANCHOR. THE SURGERY WAS DELAYED BY APPROXIMATELY 20 MINUTES, BUT NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. BONE QUALITY WAS REPORTED AS POOR. A PERCUTANEOUS 3.0 INSERTION KIT WAS USED TO PREPARE THE BONE SOCKET. NO ADVERSE PATIENT EFFECTS WERE REPORTED, AND NO PHOTOS OR VIDEOS OF THE COMPLAINT DEVICE WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23767193 ↗
• MalfunctionDec 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 11/21/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT FIVE AR-1934PF-24 PEEK SUTURETAK SUTURE ANCHORS PULLED OUT IN A SURGICAL CASE. THIS INCIDENT OCCURRED DURING A PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON 11/25/2025: THIS OCCURRED ON (B)(6) 2025, DURING A ROTATOR CUFF REPAIR WITH BICEPS TENODESIS PROCEDURE. THE CASE WAS COMPLETED USING AN AR-3632SP 2.6 FIBERTAK SP SOFT ANCHOR. THE SURGERY WAS DELAYED BY APPROXIMATELY 20 MINUTES, BUT NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. BONE QUALITY WAS REPORTED AS POOR. A PERCUTANEOUS 3.0 INSERTION KIT WAS USED TO PREPARE THE BONE SOCKET. NO ADVERSE PATIENT EFFECTS WERE REPORTED, AND NO PHOTOS OR VIDEOS OF THE COMPLAINT DEVICE WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23767135 ↗
• MalfunctionDec 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 11/21/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT FIVE AR-1934PF-24 PEEK SUTURETAK SUTURE ANCHORS PULLED OUT IN A SURGICAL CASE. THIS INCIDENT OCCURRED DURING A PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON 11/25/2025: THIS OCCURRED ON (B)(6) 2025, DURING A ROTATOR CUFF REPAIR WITH BICEPS TENODESIS PROCEDURE. THE CASE WAS COMPLETED USING AN AR-3632SP 2.6 FIBERTAK SP SOFT ANCHOR. THE SURGERY WAS DELAYED BY APPROXIMATELY 20 MINUTES, BUT NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. BONE QUALITY WAS REPORTED AS POOR. A PERCUTANEOUS 3.0 INSERTION KIT WAS USED TO PREPARE THE BONE SOCKET. NO ADVERSE PATIENT EFFECTS WERE REPORTED, AND NO PHOTOS OR VIDEOS OF THE COMPLAINT DEVICE WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23759975 ↗
• MalfunctionDec 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 11/21/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT FIVE AR-1934PF-24 PEEK SUTURETAK SUTURE ANCHORS PULLED OUT IN A SURGICAL CASE. THIS INCIDENT OCCURRED DURING A PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON 11/25/2025: THIS OCCURRED ON (B)(6) 2025, DURING A ROTATOR CUFF REPAIR WITH BICEPS TENODESIS PROCEDURE. THE CASE WAS COMPLETED USING AN AR-3632SP 2.6 FIBERTAK SP SOFT ANCHOR. THE SURGERY WAS DELAYED BY APPROXIMATELY 20 MINUTES, BUT NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. BONE QUALITY WAS REPORTED AS POOR. A PERCUTANEOUS 3.0 INSERTION KIT WAS USED TO PREPARE THE BONE SOCKET. NO ADVERSE PATIENT EFFECTS WERE REPORTED, AND NO PHOTOS OR VIDEOS OF THE COMPLAINT DEVICE WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23759877 ↗
• MalfunctionDec 9, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 11/21/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT FIVE AR-1934PF-24 PEEK SUTURETAK SUTURE ANCHORS PULLED OUT IN A SURGICAL CASE. THIS INCIDENT OCCURRED DURING A PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON 11/25/2025: THIS OCCURRED ON (B)(6) 2025, DURING A ROTATOR CUFF REPAIR WITH BICEPS TENODESIS PROCEDURE. THE CASE WAS COMPLETED USING AN AR-3632SP 2.6 FIBERTAK SP SOFT ANCHOR. THE SURGERY WAS DELAYED BY APPROXIMATELY 20 MINUTES, BUT NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. BONE QUALITY WAS REPORTED AS POOR. A PERCUTANEOUS 3.0 INSERTION KIT WAS USED TO PREPARE THE BONE SOCKET. NO ADVERSE PATIENT EFFECTS WERE REPORTED, AND NO PHOTOS OR VIDEOS OF THE COMPLAINT DEVICE WERE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23759809 ↗
• InjuryApr 10, 2019Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A CASE, THE IMPLANTS PULLED OUT. REPORTER HAS NO FURTHER DETAILS; ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION RECEIVED 3/28/2019: DURING A MODIFIED BROSTRÖM PROCEDURE, THE SURGEON PREPPED TWO PILOT HOLES IN THE PATIENT'S SOFT BONE FIBULA WITH A 2.4 SUTURETAK DRILL BIT. HE INSERTED A PEEK SUTURETAK SUTURE ANCHOR AND THE ANCHOR PULLED OUT. HE REMOVED THE ANCHOR AND OPENED A SECOND FROM THE SAME LOT AND ATTEMPTED TO INSERT THIS ANCHOR INTO THE SECOND HOLE. AGAIN, THE ANCHOR PULLED OUT. UNPLANNED BONE TUNNELS WERE DRILLED TO FINISH THE PROCEDURE VS. USING A DIFFERENT ANCHOR.

  Patient problems: Failure of Implant

  MAUDE report 8500038 ↗
• InjuryJan 30, 2019Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT AFTER HAVING AN AR-1938PS, SUTURE ANCHOR PEEK SUTURE TAK (LOT: UNKNOWN) AND AR-AR-1934PF-24, 2.4 MM PEEK SUTURETAK (LOT: UNKNOWN) IMPLANTED ON (B)(6) 2017 THE PATIENT STARTED TO EXPERIENCE AN ADVERSE REACTION APPROXIMATELY TWO TO THREE WEEKS POST-OP. THE PATENT WAS EXPERIENCING AN ITCHY RASH WITH SMALL RED DOTS ON THEIR BACK, ARMS, HANDS, THIGHS, "CALFS", TOP OF FEET, CHEST AND STOMACH. THE PATIENT INFORMED THEIR SURGEON OF THEIR SYMPTOMS AT THEIR SIX WEEK POST-OP APPOINTMENT. ALLERGY SCRATCH AND PATCH TESTING WAS PERFORMED, AND THE RESULTS REVEALED A SULFITE SENSITIVITY. THE PATIENT WENT ON A SULFITE FREE DIET FOR TWO MONTHS, BUT THE SYMPTOMS WERE STILL PRESENT. THE PATIENT HAS BEEN SEEING DERMATOLOGISTS AND ALLERGISTS TO TRY AND RESOLVE THE ISSUE. THE PATIENT HAS BEEN PRESCRIBED PREDNISONE TO TREAT SYMPTOMS.

  Patient problems: Erythema; Hypersensitivity/Allergic reaction; Itching Sensation; Rash; Reaction

  MAUDE report 8288730 ↗