Arthrex® AR-1927PSF-3Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00888867023642), received between Dec 20, 2019 and Feb 13, 2026 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 13, 2026Break

  ON (B)(6) 2026, AN ARTHREX EMPLOYEE REPORTED VIA EMAIL THAT THE AR-1927PSF-3 SUTR ANCH, PEEK CORKSCREW FT, TRI-PLAY (BATCH 15408230) EXPERIENCED A FIBERWIRE BREAKAGE UPON TENSIONING WHILE THE SURGEON WAS ANCHORING DOWN THE LATERAL ROW IN A ROTATOR CUFF CASE. THE ISSUE OCCURRED DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2026. NO FRAGMENTS BROKE OFF INSIDE THE PATIENT. THE SURGEON CONTINUED WITH THE PROCEDURE, ALTHOUGH THE SUTURES WERE NOT TENSIONED TO THE DESIRED LEVEL.

  Patient problems: Foreign Body In Patient

  MAUDE report 24334299 ↗
• MalfunctionOct 16, 2025Crack; Crack

  IT WAS REPORTED THAT DURING A SHOULDER REPAIR SURGERY THE SCREW BROKE. NO PIECE BROKE OFF; IT WAS MORE A CRACK IN THE SCREW. PER COMPLAINT REPORTER 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 23315906 ↗
• MalfunctionNov 1, 2024Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SURGERY THE METAL PART FROM ANCHOR BROKE DOWN AND WAS LEFT INSIDE THE ANCHOR. ALL PARTS WERE RETRIEVED. PER COMPLAINT REPORTER 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 20589780 ↗
• MalfunctionJun 19, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING ARTHROSCOPY THE SUTURE DID RIP OFF AT THE SUTURE ATTACHMENT WHILE TRYING TO PULL THE ANCHOR. THE BROKEN OFF PIECE HAS BEEN RETRIEVED FROM THE PATIENT. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. 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. NO FURTHER INFORMATION RECEIVED. UPDATE, 11-MAY-2021 -SAC RECEIVED FURTHER INFORMATION THAT THE ANCHOR HAS ALREADY BEEN FULLY INSERTED WHEN THE THREAD DID RIP OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19569823 ↗
• MalfunctionJan 23, 2024Defective Device; Defective Device

  ON 01/04/2024, IT WAS REPORTED BY A ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1927PSF-3 SUTURE ANCHOR SHAFT IS DAMAGED. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18565345 ↗
• MalfunctionOct 10, 2023Break; Break

  IT WAS REPORTED THAT DURING A LABRUM REFIXATION SURGERY THE TIP OF THE DEVICE BROKE OFF. 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. UPDATE AVOE 26-SEP-2023: IT WAS CONFIRMED THAT THE DEVICE BROKE INSIDE THE PATIENT AND ALL FRAGMENTS WERE RETRIEVED.

  Patient problems: Failure of Implant

  MAUDE report 17908368 ↗
• MalfunctionJul 28, 2023Break; Break

  UPDATE AVOE 25-SEP-2023. FURTHER INFORMATION WAS PROVIDED THAT THE ERROR OCCURRED ON THE 17.5.2023 DURING A ROTATOR KNOTTED REPAIR SURGERY. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17413953 ↗
• MalfunctionJul 25, 2022Break; Crack

  ON 7/7/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1927PSF-3 PEEK CORKSCREW ANCHOR CRACKED AFTER ONLY A FEW SPINS. SURGEON OPENED ANOTHER AR-1927PSF-3 PEEK CORKSCREW ANCHOR FROM A DIFFERENT LOT NUMBER AND THE SAME THING HAPPENED. AFTER INSERTING THE ANCHOR AND A COUPLE OF SPINS, IT BROKE. EVERYTHING WAS REMOVED FROM INSIDE THE PATIENT AND SURGEON COMPLETE THE CASE WITH A THIRD AR-1927PSF-3 PEEK CORKSCREW ANCHOR FROM THE SAME LOT NUMBER AS THE FIRST ANCHOR THAT BROKE. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 15093441 ↗
• MalfunctionJul 25, 2022Break; Crack

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1927PSF-3 PEEK CORKSCREW ANCHOR CRACKED AFTER ONLY A FEW SPINS. SURGEON OPENED ANOTHER AR-1927PSF-3 PEEK CORKSCREW ANCHOR FROM A DIFFERENT LOT NUMBER AND THE SAME THING HAPPENED. AFTER INSERTING THE ANCHOR AND A COUPLE OF SPINS, IT BROKE. EVERYTHING WAS REMOVED FROM INSIDE THE PATIENT AND SURGEON COMPLETE THE CASE WITH A THIRD AR-1927PSF-3 PEEK CORKSCREW ANCHOR FROM THE SAME LOT NUMBER AS THE FIRST ANCHOR THAT BROKE. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 15093320 ↗
• MalfunctionMay 24, 2021Break

  IT WAS REPORTED THAT THE SUTURE ANCHOR WITH PEEK TIP COULD NOT BE SCREWED IN, IT BROKE OFF IN THE DRIVER AT THE SUTURE ATTACHMENT. THE BROKEN PIECE WAS RETRIEVED. NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY WAS REPORTED. 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 11872133 ↗
• InjuryDec 20, 2019Break; Difficult to Remove

  IT WAS REPORTED THAT DURING A SHOULDER STABILISATION + REMPLISSAGE PROCEDURE, THE SURGEON INSERTED TWO 5.5 CORKSCREWS, AR-1927PSF-3, IN THE HUMERUS. ON FINAL INSERTION OF THE SECOND ANCHOR, THE ENTIRE LENGTH OF THE METAL TIP OF THE INSERTER SNAPPED OFF IN THE ANCHOR AND WAS UNABLE TO BE RETRIEVED WITHOUT COMPROMISING THE SURROUNDING BONE. THE ANCHOR WAS INSERTED AS PER THE RECOMMENDED TECHNIQUE. THE REMPLISSAGE WAS COMPLETED AS NORMAL WITH THE METAL TIP TO REMAIN IN THE PATIENT. UNABLE TO DETERMINE WHICH BATCH WAS USED. EITHER 10318985 OR 10327444.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9506236 ↗