Arthrex® AR-1923PKRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867096745), received between Feb 15, 2019 and Jun 5, 2024 — classified as 1 injury, 5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2024Defective Device; Defective Device

  ON 1/10/2022 , IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1923PK PERCUTANEOUS INSERTION KIT DILATOR DID NOT FIT THE CANNULA BECAUSE IS WAS TOO BIG. THIS WAS DISCOVERED UPON OPENING PACKAGE DURING A LABRAL REPAIR PROCEDURE ON (B)(6) 2022. SURGEON OPENED ANOTHER KIT AND CASE WAS COMPLETED WITHOUT FURTHER ISSUES.

  Patient problems: Insufficient Information

  MAUDE report 19472619 ↗
• MalfunctionMay 10, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A POSTERIOR STABLIZATION THE NITINOL WIRE DOES NOT RUN SMOOTHLY THROUGH THE BIG NEEDLE. THE SURGEON REPORTED THAT 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 19285208 ↗
• MalfunctionApr 30, 2024Device Damaged by Another Device; Device Damaged by Another Device

  IT WAS REPORTED THAT DURING A POSTERIOR STABLIZATION THE NITINOL WIRE DOES NOT RUN SMOOTHLY THROUGH THE BIG NEEDLE. THE SURGEON REPORTED THAT 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 19215397 ↗
• MalfunctionFeb 8, 2024Material Twisted/Bent; Material Twisted/Bent

  ON 01/18/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1923PK PERCUTANEOUS INSERTION KIT HAD A CRIMP THAT CAUSED AN ISSUE WITH INSERTION. THIS OCCURRED DURING A CASE. NO ADDITIONAL INFORMATION WAS PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN ASKED.

  Patient problems: Insufficient Information

  MAUDE report 18669794 ↗
• MalfunctionJun 8, 2021Break

  IT WAS REPORTED VIA A MEDWATCH LETTER THAT A GUIDEWIRE WAS MISSING FROM THE TRAY, SO A SUBSTITUTE WIRE WAS USED FROM THE AR-1923PK DISPOSABLE INSTRUMENT KIT FOR TENODESIS SCREW. THE END OF THE WIRE BROKE OFF INTO PATIENT, BUT WAS RETRIEVED PRIOR TO CLOSURE OF INCISION.

  Patient problems: Insufficient Information

  MAUDE report 11956478 ↗
• InjuryFeb 15, 2019Break

  IT WAS REPORTED THAT THE AR-1923PK WAS BEING USED FOR A SLAP REPAIR ON A (B)(6) MALE PATIENT. THE GUIDE WIRE BROKE AFTER GOING THROUGH THE CUFF. THE BROKEN PIECE WAS REMOVED; IT REQUIRED A SMALL ADDITIONAL INCISION ABOUT AN INCH BELOW THE LATERAL INCISION TO RETRIEVE THE BROKEN PIECE. THE CASE WAS COMPLETED WITH A PUSHLOCK ANCHOR.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8344401 ↗