Arthrex® AR-1928SF-45Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00888867023741), received between Jan 2, 2019 and Feb 25, 2025 — classified as 1 injury, 7 malfunctions.

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

• MalfunctionFeb 25, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE TIP OF THE CORKSCREW BROKE OFF WHEN TURNING THE CORKSCREW INTO THE BONE. ALL BROKEN PARTS WERE RETRIEVED FROM THE PATIENTS. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT 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 21458332 ↗
• MalfunctionFeb 25, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE TIP OF THE CORKSCREW BROKE OFF WHEN TURNING THE CORKSCREW INTO THE BONE. ALL BROKEN PARTS WERE RETRIEVED FROM THE PATIENTS. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT 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 21458168 ↗
• MalfunctionOct 4, 2021Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY SURGERY THE TITANIUM TIP OF THE DEVICE BROKE WHEN ATTACHING THE ANCHOR TO THE BONE. ALL FRAGMENTS WERE REMOVED 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 12569245 ↗
• MalfunctionJul 13, 2021Break

  IT WAS REPORTED THAT WITH THE FIRST TWO ATTEMPTS, THE TIPS OF THE ANCHORS BROKE AT INSERTION. THE TIPS WERE RETRIEVED FROM THE PATIENT AND ANOTHER ANCHOR WAS USED TO COMPLETE THE RCR CASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12163260 ↗
• MalfunctionJul 13, 2021Break

  IT WAS REPORTED THAT WITH THE FIRST TWO ATTEMPTS, THE TIPS OF THE ANCHORS BROKE AT INSERTION. THE TIPS WERE RETRIEVED FROM THE PATIENT AND ANOTHER ANCHOR WAS USED TO COMPLETE THE RCR CASE.

  Patient problems: Insufficient Information

  MAUDE report 12163251 ↗
• MalfunctionJun 1, 2021Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE LITTLE PIN IN THE CENTER OF THE SCREEN HOLDING THE FIBER WIRE CAME OFF, RESULTING IN THE FIBER WIRE PULLING OUT. THERE WAS NO HARM FOR PATIENT, USER OR THIRD-PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY. UPDATE (B)(6) 2021: A PIECE BROKE OFF INSIDE THE PATIENT. IT WAS RECOVERED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11912001 ↗
• MalfunctionMar 31, 2021Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A SHOULDER CUFF REPAIR SURGERY THE LITTLE PIN IN THE CENTER OF THE SCREEN, HOLDING THE FIBER WIRE, CAME OFF. DUE TO THIS FAILURE THE FIBER WIRE PULLED OUT. THE SURGEON WAS ABLE TO RETRIEVE THE PIECE OUT OF 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. UPDATE 12-MAR-2021: FURTHER INFORMATION WAS PROVIDED THAT THE PIN IN THE CENTER OF THE SCREW THAT HOLDS THE SUTURES OF THE 4.5MM CORKSCREW ANCHOR CAME OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11599212 ↗
• InjuryJan 2, 2019Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPIC PROCEDURE, THE SUTURE ANCHOR, AR-1928SF-45, BROKE UPON INSERTION. THE CASE WAS COMPLETED BY USING ANOTHER SUTURE ANCHOR. FURTHER INFORMATION REQUESTED.

  Patient problems: No Code Available

  MAUDE report 8208823 ↗