Arthrex® AR-1938PS-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00888867282421), received between Oct 5, 2021 and Mar 30, 2026 — classified as 11 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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2026Positioning Failure

  IT WAS REPORTED THAT DURING A SURGERY THE ANCHOR DID NOT HOLD AND CAME LOOSE DURING TIGHTENING. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24713226 ↗
• MalfunctionApr 21, 2025Positioning Failure; Fitting Problem; Positioning Failure; Fitting Problem

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY THE DEVICE COULD NOT BE ANCHORED. 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 21873442 ↗
• MalfunctionApr 18, 2025Break; Device Damaged by Another Device; Break; Device Damaged by Another Device

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY THE SIGHT GOT DISINTEGRATED AND THE ANCHOR BECAME DAMAGED. 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 21865795 ↗
• MalfunctionApr 18, 2025Break; Device Damaged by Another Device; Break; Device Damaged by Another Device

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY THE SIGHT GOT DISINTEGRATED AND THE ANCHOR BECAME DAMAGED. 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 21865577 ↗
• MalfunctionFeb 20, 2025Use of Device Problem; Failure to Advance; Use of Device Problem; Failure to Advance

  IT WAS REPORTED THAT DURING A KNEE CAPSULE REPAIR SURGERY THE SUTURE DID NOT TIGHTEN. 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 21425184 ↗
• MalfunctionFeb 20, 2025Use of Device Problem; Failure to Advance; Use of Device Problem; Failure to Advance

  IT WAS REPORTED THAT DURING A KNEE CAPSULE REPAIR SURGERY THE SUTURE DID NOT TIGHTEN. 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 21424979 ↗
• MalfunctionMay 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LABRUM REFIXATION SURGERY WITH KNOTLESS SUTURETAK WHEN INSERTING THE ANCHOR, THE PEEKHART BODY HELD UNDER TENSION, BUT WHEN SHUTTLING AND INSERTING THE TENSION AND MAIN SUTURE, THE ANCHORS CAME LOOSE AND WERE DISCARDED AND REPLACED BY 2 NEW ANCHORS. 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 19329625 ↗
• MalfunctionMay 16, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LABRUM REFIXATION SURGERY WITH KNOTLESS SUTURETAK WHEN INSERTING THE ANCHOR, THE PEEKHART BODY HELD UNDER TENSION, BUT WHEN SHUTTLING AND INSERTING THE TENSION AND MAIN SUTURE, THE ANCHORS CAME LOOSE AND WERE DISCARDED AND REPLACED BY 2 NEW ANCHORS. 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 19329518 ↗
• MalfunctionApr 25, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A BANKART AND SLAP REPAIR SURGERY WHEN DRIVING THE ANCHOR IN, IT WAS DAMAGED AND NO STABILITY WAS OBTAINED. THE BONE WAS PROPERLY PREPARED. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE, AR-2325BSS-1. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19180389 ↗
• MalfunctionApr 10, 2024Material Rupture; Material Rupture

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY SURGERY THERE WAS A RUPTURE OF THE BINDING SUTURE OF THE DEVICE DURING COLLARBONE STABILISATION. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. 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 19080855 ↗
• MalfunctionOct 5, 2021Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A SURGERY IT WAS NOT POSSIBLE TO IMPLANT THE DEVICES COMPLETELY. THE DEVICES GOT STUCK AND NO FURTHER TIGHTENING OF THE SUTURES WAS POSSIBLE. NO PART OF THE DEVICES BROKE OFF. THE TWO DEVICES WITH THE SAME ERROR REMAINED INSIDE THE PATIENT AND THE SURGEON SWITCHED THE PROCEDURE FROM A KNOTLESS TO A KNOTTED PROCEDURE. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (1934BC). IT WAS NOT NECESSARY TO DO A SECOND SURGERY. UPDATE 22-SEP-2021: IT WAS CONFIRMED THAT IT WAS NOT POSSIBLE TO PERFORM THE FINAL TIGHTENING OF THE AFFECTED DEVICES AND THESE WERE NOT REMOVED BECAUSE DRILLING OVER THEM WOULD ONLY HAVE CAUSED MORE DAMAGE TO THE PATIENT. NEW TUNNELS HAD TO BE DRILLED FOR THE KNOTTED ANCHORS. UPDATE 27-SEP-2021: IT WAS CONFIRMED THAT THE ERROR OCCURRED DURING A SHOULDER (LABRUM) SURGERY. AFTER THE SUTURES GOT STUCK, THEY WERE CUT FROM THE ANCHORS AND REMOVED. THE ANCHOR BODIES REMAINED FULLY IMPLANTED INSIDE THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 12576867 ↗