Arthrex® AR-1934-24DSRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867023864), received between Mar 21, 2022 and Jan 20, 2026 — classified as 7 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 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.

• MalfunctionJan 20, 2026Physical Resistance/Sticking

  IT WAS REPORTED THAT THE DRILL BECAME STUCK INSIDE THE GUIDE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THIS WAS NOTICED BEFORE THE SURGERY. THERE WAS NO CASE INVOLVEMENT REPORTED. NO FURTHER INFORMATION RECEIVED. UPDATE 15-JAN-2025: FURTHER INFORMATION WAS RECEIVED, ON 05-JAN-2026, THAT THE CASE OCCURRED DURING A SURGERY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW ANCHOR. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24114343 ↗
• MalfunctionJun 27, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 06/05/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1934-24DS BIO-SUTURETAK DISPOSABLE KIT GUIDES CAME OUT BUT THE OBTURATORS WERE STUCK INSIDE OF THEM AND THE DRILLS DID NOT PASS THROUGH THE GUIDES. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22349482 ↗
• MalfunctionMay 1, 2025Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER INSTABILITY REPAIR SURGERY AN ISSUE WITH THE REPORTED DEVICE HAS OCCURRED. THE SURGEON HAS DRILLED THE HOLE AND WHEN HE TRIED TO REMOVE THE DRILL, IT THAT GOT STUCK. THE TIP OF THE DRILL FUSED WITH PART OF THE SLEEVE, WHILE THE LOWER PART, WHERE THE DRILL IS ATTACHED, BROKE OFF. THE PIECE WAS RECOVERED AND DID NOT REMAIN INSIDE THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW 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 21942701 ↗
• MalfunctionJun 19, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT AFTER USING THE AR-1934-24DS THE DRILL BIT COULD NOT BE REMOVED FROM THE DRILL GUIDE. NO ADVERSE EFFECT TO THE PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19567099 ↗
• MalfunctionMay 21, 2024Break; Break

  IT WAS REPORTED ON (B)(6) 2023 BY AN ARTHREX EMPLOYEE VIA SEMS THAT AN AR-1934-24DS DRILL BIT GOT STUCK IN THE AR-1934BCF-24-2 DRILL SLEEVE. IT WAS USED AT THE ELBOW HEAD. USED A NEW PRODUCT, AND THE CASE WAS COMPLETED. CASE INVOLVEMENT, NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19359468 ↗
• MalfunctionJan 3, 2023Break; Mechanical Jam

  ON (B)(6) 2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT A DRILL FROM AN AR-1934-24DS BIO-SUTURETAK DISPOSABLE KIT, GOT STUCK INSIDE THE GUIDE AND COULD NOT BE REMOVED. WHILE ATTEMPTING TO REMOVE IT, THE DRILL BROKE. A NEW PRODUCT WAS USED, AND CASE WAS COMPLETED. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16086969 ↗
• MalfunctionMar 21, 2022Break

  ON 01/06/2022 IT WAS REPORTED BY A ARTHREX REPRESENTATIVE VIA SEMS THAT AN AR-1934-24DS, THE DRILL BIT BREAKAGE STACKED IN THE DRILL GUIDE, THE TIP OF THE DRILL WAS DAMAGED. THE CASE WAS COMPLETED USING THE NEW PRODUCT IN THE SAME LOT. NO PATIENT HARMS. ADDITIONAL INFORMATION 1/13/2022: ON 01/13/2022 IT WAS REPORTED BY A ARTHREX REPRESENTATIVE VIA SEMS THAT AN AR-1934-24DS, DURING A PROCEDURE THE DRILL BUT WAS STUCK INSIDE THE DRILL GUIDE. THE DRILL TIP WAS DAMAGED DURING DRILLING, NO DEBRIS CAME OFF THE DEVICE. THE CASE WAS COMPETED USING A NEW AR-1934-24DS. DURING RETURNED DEVICE EVALUATION, A REPORTABLE MALFUNCTION WAS DISCOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13839475 ↗