Arthrex® AR-1923DSRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867023079), received between Oct 23, 2019 and Oct 20, 2025 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Component Missing” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 20, 2025Dull, Blunt; Dull, Blunt

  ON 10/14/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-1923DS DISPOSABLES KIT DRILL WAS NOT AS SHARP AS USUAL, SO THE DOCTOR STOPPED USING IT AND OPENED ANOTHER ONE OF THE SAME PRODUCTS, WHICH ALLOWED HIM TO COMPLETE THE PROCEDURE WITHOUT ANY PROBLEMS. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23335642 ↗
• MalfunctionNov 7, 2023Component Missing; Component Missing

  ON 10/13/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1923DS DISPOSABLE KIT WAS PACKAGED WRONG AND HAD NO DRILL BIT INSIDE. THIS WAS DISCOVERED OUT OF THE BOX IN A CASE.

  Patient problems: Insufficient Information

  MAUDE report 18085878 ↗
• MalfunctionNov 6, 2023Component Missing; Component Missing

  ON 10/10/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT (QTY. 3) OF AN AR-1923DS DISPOSABLE KIT FOR 2.9 MM PUSHLOCK WAS MISSING THE 2.9 DRILL BIT AND HAD AN UNKNOWN COMPONENT IN THE PACKAGE. THE CASE WAS COMPLETED OPENING A DIFFERENT KIT. THIS WAS DISCOVERED UPON OPENING THE PACKAGE DURING A UNSPECIFIED PROCEDURE ON (B)(6) 2023 WITH NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18073929 ↗
• MalfunctionNov 2, 2023Component Missing; Component Missing

  ON (B)(6) 2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1923DS DISPOSABLE KIT CONTAINED AN INCORRECT COMPONENT. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION IS REQUESTED. ADDITIONAL INFORMATION PROVIDED BY THE SALES REPRESENTATIVE: THE DEVICE WAS USED DURING A SHOULDER LABRAL REPAIR. THE CASE WAS COMPLETED BY USING A CONMED ANCHOR DRILL WITH NO PATIENT HARM. DEVICE WILL BE RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18055583 ↗
• InjuryOct 23, 2019Overheating of Device

  IT WAS REPORTED DURING A BANKART PROCEDURE, AS THE SURGEON WAS USING THE AR-1923DS DISPOSABLE KIT FOR 2.9 MM PUSHLOCK TO DRILL FOR THE SECOND PUSHLOCK, THE DRILL WELDED TO THE DRILL GUIDE. WHEN THE SURGEON TRIED TO SEPARATE THE TWO, THE DRILL HEATED UP SO MUCH THAT IT MELTED THE HANDLE, AND SLID DOWN THE SHAFT OF THE GUIDE. THE SURGICAL ASSISTANT GRABBED THE DRILL, AND THE DRILL ENDED UP BURNING THEIR HAND. A SECOND DRILL GUIDE WAS NOT AVAILABLE. A 2.5 GUIDE WIRE WAS USED TO CREATE A HOLE FOR THE INSERTION OF THE PUSHLOCK. TWO ADDITIONAL PUSHLOCKS WERE IMPLANTED USING THIS METHOD. THE REP REPORTED THE PROCEDURE WAS COMPLETED AND THE PATIENT OUTCOME WAS GOOD. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED ON 10/08/2019: THE REP STATED THAT THE BURN WAS MINOR, AND THERE ARE NO AVAILABLE PICTURES OF THE BURN. THE DOCTOR RAN THE BURN UNDER COLD WATER. THE REP REPORTED THE DRILL DID NOT COME INTO CONTACT WITH THE PATIENT, AND NO OTHER INDIVIDUAL WAS BURNED. NO ADDITIONAL INCISIONS WERE NECESSARY. THE DEVICE WILL BE RETURNING FOR EVALUATION.

  Patient problems: Burn, Thermal

  MAUDE report 9225969 ↗