Arthrex® AR-1927PSFRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00888867023628), received between Jun 27, 2017 and Dec 27, 2021 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 27, 2021Break

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1927PSF PEEK CORKSCREW SUTURE ANCHOR BROKE PREMATURELY. THIS WAS DISCOVERED DURING AN RCR REPAIR PROCEDURE ON (B)(6) 2021. SURGEON COMPLETED THE CASE USING A 6.5 ANCHOR INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13087870 ↗
• InjuryDec 17, 2019Loose or Intermittent Connection

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RCR PROCEDURE ON (B)(6) 2019 WHERE A PEEK CORKSCREW SUTURE ANCHOR, AR-1927PSF, AND A PUSHLOCK SUTURE ANCHOR, AR-1926PS, WERE IMPLANTED. THE SURGERY WAS COMPLETED WITH NO ISSUES. ABOUT TWO WEEKS LATER, THE PATIENT PRESENTED WITH PAIN IN THEIR SHOULDER IN THE GENERAL JOINT. THE SURGEON DECIDED TO REMOVE THE IMPLANTS AS THE PATIENT MAY HAVE HAD AN INFECTION. DURING THE REVISION, THE MEDIAL IMPLANT WAS FOUND TO BE A LITTLE LOOSE BUT DID NOT APPEAR TO BE INFECTED. BOTH IMPLANTS EXPLANTED AND THE SURGEON DID NOT REPLACE THEM WITH ANY HARDWARE. THE SURGEON SENT THE IMPLANTS TO PATHOLOGY FOR CULTURES AND FLUSHED THE JOINT. RESULTS FROM THE CULTURES WILL BE PROVIDED ONCE AVAILABLE. ANTIBIOTICS WERE PRESCRIBED TO THE PATIENT. PATIENT IS A MALE, (B)(6).

  Patient problems: Pain

  MAUDE report 9482930 ↗
• InjuryJun 27, 2017Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A ROTATOR CUFF REPAIR ON (B)(6) 2017 WHERE A BIO-COMPOSITE SWIVELOCK TENODESIS SUTURE ANCHOR, AR-1662BC-7 (CC116304, LINE 195529) WAS IMPLANTED INTO THE PATIENT'S SHOULDER. APPROXIMATELY FOUR DAYS AFTER THE SURGERY, THE PATIENT BEGAN TO EXPERIENCE TROUBLE BREATHING AND SWELLING IN THE THROAT. THE PATIENT HAS BEEN TREATED AT THE ER FOR SYMPTOMS. NO REDNESS OR SWELLING CAN BE SEEN AT THE SURGERY SITE. THE PATIENT CLAIMS THEY HAVE NEVER HAD ANY ISSUES OF THIS NATURE UNTIL AFTER THEIR PROCEDURE. THE PATIENT'S ONLY KNOWN ALLERGY IS PENICILLIN. THE BELOW PART NUMBERS WERE ALSO IMPLANTED ON (B)(6). AR-1662BC LOT 10110092 1EA (CC116304, LINE 197799), AR-1927PSF LOT 10068319 1EA (CC116304, LINE 197800), AR-1926PS LOT 10064848 1EA (CC116304, LINE 197801) AND AR-1926PS LOT 10053400 1EA (CC116304, LINE 197802).

  Patient problems: Respiratory Distress; Swelling

  MAUDE report 6671321 ↗