Arthrex® AR-1927PSF-475Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867238602), received between Oct 30, 2019 and Sep 17, 2024 — classified as 2 injuries, 3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2024Break; Break

  ON 09/4/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1927PSF-475 PEEK CORKSCREW FT BROKE DURING INSERTION. THE CASE WAS COMPLETED USING ANOTHER AR-1927PSF-475 PEEK CORKSCREW FT. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 9/11/2024: ALL THE BROKEN FRAGMENTS WERE SUCCESSFULLY REMOVED. THE CASE WAS NOT DELAYED, AND ADDITIONAL ANESTHESIA WAS NOT NEEDED.

  Patient problems: Insufficient Information

  MAUDE report 20238737 ↗
• InjuryJun 19, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA PHONE THAT AN AR-2324BCC SUTURELOCK AND AR-1927PSF-475 CORKSCREW ANCHOR WERE IMPLANTED ON (B)(6) 2023. PATIENT RETURNED TO THE FACILITY WITH AN INFECTION ON (B)(6) 2023. THIS HAS NOT BEEN A REVISION SCHEDULED AS OF (B)(6) 2023.

  Patient problems: Unspecified Infection

  MAUDE report 17152385 ↗
• MalfunctionOct 26, 2021Break

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (2) AR-1927PSF-475 PEEK CORKSCREW BROKE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2021, WHEN SURGEON PUNCHED IN PREPARATION FOR IMPLANT, BOTH SUTURE ANCHOR PEEK CORKSCREW BROKE DURING INSERTION.

  Patient problems: Insufficient Information

  MAUDE report 12696960 ↗
• MalfunctionOct 26, 2021Break; Activation, Positioning or Separation Problem

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (2) AR-1927PSF-475 PEEK CORKSCREW BROKE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2021, WHEN SURGEON PUNCHED IN PREPARATION FOR IMPLANT, BOTH SUTURE ANCHOR PEEK CORKSCREW BROKE DURING INSERTION.

  Patient problems: Insufficient Information

  MAUDE report 12696947 ↗
• InjuryOct 30, 2019Break; Material Twisted/Bent

  IT WAS REPORTED DURING A ROTATOR CUFF REPAIR PROCEDURE, THE AR-1927PSF-475 SUTURE ANCHOR PEEK CORKSCREW BROKE UPON INSERTION. THE REP STATED THE TIP OF THE CORKSCREW WAS LEFT IN THE BONE, AND THE REMAINDER OF THE IMPLANT WAS RETRIEVED BY USING A GRASPER. A NEW HOLE WAS DRILLED BY USING THE AR-1927PTB-475, PUNCH/TAP (LOT: 011919) AND A SECOND AR-1927PSF-475 FROM THE SAME LOT WAS IMPLANTED WITHOUT ISSUE. HOWEVER, AS THE SURGEON WAS DRILLING THE NEW HOLE THE TIP OF THE AR-1927PTB-475 BENT. THE REP REPORTED NOTHING BROKE OFF FROM THE PUNCH/TAP. THE RETRIEVED BROKEN PORTION OF THE CORKSCREW AND THE BENT PUNCH/TAP WILL BE RETURNING FOR EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9254968 ↗