Arthrex® AR-1927PSF-45Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00888867023666), received between Sep 24, 2018 and Sep 19, 2025 — classified as 4 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2025Break; Break

  ON 2ND SEP 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-1927PSF-45, 4.5 MM PEEK CORKSCREW® FT SUTURE ANCHOR WITH ONE #2 FIBERWIRE® AND ONE # 2 TIGERWIRE®, THE ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2025. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY USING ANOTHER NEW AR-1927PSF-45. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23095816 ↗
• MalfunctionSep 19, 2025Break; Break

  ON 2ND SEP 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-1927PSF-45, 4.5 MM PEEK CORKSCREW® FT SUTURE ANCHOR WITH ONE #2 FIBERWIRE® AND ONE # 2 TIGERWIRE®, ITS ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1927PSF-45. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23095723 ↗
• MalfunctionAug 13, 2025Break; Break

  ADDITIONAL INFORMATION: THERE IS NO PATIENT HARM.

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

  MAUDE report 22794046 ↗
• MalfunctionAug 8, 2025Break; Break

  ON 22ND JULY 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA EMAIL THAT FOR AN AR-1927PSF-45, 4.5 MM PEEK CORKSCREW® FT SUTURE ANCHOR WITH ONE #2 FIBERWIRE® AND ONE # 2 TIGERWIRE®, ITS ANCHOR BROKE DURING INSERTION AND THE SUTURE PULLED OUT. THIS WAS DETECTED DURING AN OPEN REDUCTION AND INTERNAL FIXATION OF FRACTURES SURGERY ON (B)(6) 2025. THE CASE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1927PSF-45. THERE WAS NO PATIENT HARM, AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22749446 ↗
• MalfunctionAug 6, 2024Break; Break

  ON 22ND JULY 2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1927PSF-45, 4.5 MM PEEK CORKSCREW® FT SUTURE ANCHOR WITH ONE #2 FIBERWIRE® AND ONE # 2 TIGERWIRE®, ANCHOR WAS BROKEN DURING INSERTION. THIS WAS DETECTED DURING USE IN A ROTATOR CUFF PROCEDURE ON (B)(6) 2024. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1927PSF-45, NO PATIENT HARM AND NO SECONDARY PROCEDURE WAS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19920029 ↗
• MalfunctionAug 6, 2024Material Deformation; Material Deformation

  ON 22ND JULY 2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1927PSF-45, 4.5 MM PEEK CORKSCREW® FT SUTURE ANCHOR WITH ONE #2 FIBERWIRE® AND ONE # 2 TIGERWIRE®, THE HEAD OF THE ANCHOR WAS DEFORMED DURING INSERTION. THIS WAS DETECTED DURING USE IN A ROTATOR CUFF PROCEDURE ON (B)(6) 2024. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1927PSF-45, NO PATIENT HARM AND NO SECONDARY PROCEDURE WAS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19919607 ↗
• MalfunctionFeb 5, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA E-MAIL THAT AN AR-1927PSF-45 4.5 MM PEEK CORKSCREW BROKE. THIS OCCURRED DURING AN INTERCONDYLAR FRACTURE OF THE TIBIA ON (B)(6) 2024, WHERE THE BONE SOCKET WAS PREPARED USING AN AR-1922P PUNCH AND THE AR-1927PSF-45. UPON INSERTING THE ANCHOR, IT BROKE. THE CASE WAS COMPLETED USING AN AR-1927PSF-45 4.5 MM PEEK CORKSCREW. NO ADDITIONAL INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION HAS BEEN ASKED.

  Patient problems: Insufficient Information

  MAUDE report 18639966 ↗
• MalfunctionJan 22, 2024Break; Break

  ON 01/02/2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1927PSF-45 ANCHOR WAS BROKEN DURING INSERTION. THE PROCEDURE WAS COMPLETED BY USING ANOTHER NEW AR-1927PSF-45, NO PATIENT HARM AND NO SECONDARY PROCEDURE WAS NEEDED. ALL FRAGMENTS WERE RETRIEVED. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18553233 ↗
• MalfunctionJan 22, 2024Break; Break

  ON 01/02/2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1927PSF-45 ANCHOR WAS BROKEN DURING INSERTION. THE PROCEDURE WAS COMPLETED BY USING ANOTHER NEW AR-1927PSF-45, NO PATIENT HARM AND NO SECONDARY PROCEDURE WAS NEEDED. ALL FRAGMENTS WERE RETRIEVED. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18552391 ↗
• MalfunctionJan 19, 2024Break; Break

  ON 12/11/2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-1927PSF-45 PEEK CORKSCREW FT ANCHOR BROKE DURING INSERTION. THE CASE WAS COMPLETED USING ANOTHER AR-1927PSF-45 PEEK CORKSCREW. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2023. ALL THE BROKEN FRAGMENTS WERE REMOVED, AND THE CASE WAS DELAYED FIFTEEN MINUTES; HOWEVER, NO ADDITIONAL ANESTHESIA WAS NEEDED.

  Patient problems: Insufficient Information

  MAUDE report 18547502 ↗
• MalfunctionDec 18, 2023Defective Device; Defective Device

  ON 11/20/2023, IT WAS REPORTED BY A FACILITY REPRESENTATIVE VIA (B)(4) THAT AN AR-1927PSF-45 4.5 MM PEEK CORKSCREW WAS DEFECTIVE WITH NO FURTHER INFORMATION PROVIDED. THIS WAS DISCOVERED DURING AN UNSPECIFIED TIME, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18352125 ↗
• MalfunctionOct 27, 2023Material Twisted/Bent; Material Twisted/Bent

  ON (B)(6) 2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-1927PSF-45 PEEK CORKSCREW FT SUTURES WERE KNOTTED WHEN THE SHAFT WAS REMOVED. THIS WAS DISCOVERED DURING AN RC REPAIR PROCEDURE ON (B)(6) 2023. THE CASE WAS COMPLETED USING ANOTHER AR-1927PSF-45 PEEK CORKSCREW FT. NO DELAY, NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18022372 ↗
• MalfunctionDec 12, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1927PSF-45 PEEK CORKSCREW FT SUTURE ANCHOR BROKE DURING INSERTION. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2022 AND COMPLETED USING ANOTHER AR-1927PSF-45 PEEK CORKSCREW FT SUTURE ANCHOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15961378 ↗
• InjuryFeb 11, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT STARTED EXPERIENCING PAIN AND STIFFNESS IMMEDIATELY (WITHIN DAYS) AFTER HAVING A PRIMARY ROTATOR CUFF REPAIR PERFORMED ON (B)(6) 2019. THE FOLLOWING ARTHREX PARTS WERE IMPLANTED DURING THE PRIMARY PROCEDURE: AR-2324PSLC (LOT: 10280045) / QTY.: 1, AR-1927PSF-45 (LOT: 10272136) / QTY.: 1. CULTURES WERE TAKEN, AND THE RESULTS WERE NEGATIVE FOR INFECTION. THE REP REPORTED THE SURGEON AND THE PATIENT'S ALLERGIST WOULD LIKE TO DO A MATERIAL TEST TO DETERMINE IF THE ALLERGY IS A POSSIBLE SOURCE OF PAIN/ STIFFNESS BEFORE TREATING THE PRIMARY REPAIR THAT WAS DONE. THE PATIENT IS SCHEDULED FOR A CAPSULAR RELEASE DUE TO STIFFNESS. ADDITIONAL INFORMATION RECEIVED ON 12/31/2019: THE REP REPORTED TO THE SURGEON'S KNOWLEDGE THE PATIENT IS NOT EXPERIENCING ANY OTHER SYMPTOMS OTHER THAN PAIN AND STIFFNESS AT THIS TIME. THE SURGEON WOULD LIKE TO PERFORM AN ALLERGY TEST OF THE PRODUCT COMPOSITION PRIOR TO REMOVING ANY IMPLANT. HOWEVER, DEPENDING ON HOW THE REPAIR LOOKS THE SURGEON MAY REMOVE THE IMPLANTED PRODUCT. THE SURGEON STATED THEY WOULD LIKE FOR ALL DUE-DILIGENCE TO BE DONE BEFORE ANY REPAIRS ARE REMOVED AND RE-DONE. THE REP IS FOLLOWING UP WITH THE SURGEON TO OB

  Patient problems: Pain

  MAUDE report 9695168 ↗
• InjuryOct 11, 2019Patient-Device Incompatibility

  IT WAS REPORTED BY A PATIENT THROUGH THE ARTHREX WEBSITE THAT THE PATIENT HAD UNDERGONE TENDON REPAIR GLUTEN MEDIUS SURGERY USING ARTHREX ANCHORS IN (B)(6) 2017 (SPECIFIC (B)(6) 2017 DATE NOT PROVIDED IN THE INITIAL REPORT). THE PATIENT INDICATED THAT THE SURGEON HAD USED SUTURE ANCHOR (4.5 MM 2 FT) AND CORKSCREW FIBER WIRE (14 MM). (SPECIFIC ARTHREX PRODUCT NUMBERS WERE NOT PROVIDED IN THE INITIAL REPORT). THE PATIENT STATES THE SURGEON BELIEVES THAT THE PATIENT IS HAVING AN ALLERGIC REACTION TO THE SUTURE MATERIAL ANCHORED IN THE BONES. PATIENT IS REQUESTING MATERIAL COMPOSITION INFORMATION TO BE USED FOR POSSIBLE TESTING FOR HYPERSENSITIVITY/ALLERGIES. PATIENT ALSO STATES THAT PAIN AND INFLAMMATION HAVE CONTINUED. ADDITIONAL INFORMATION OBTAINED 9/16/19: PATIENT HAS PROVIDED THE OPERATIVE REPORT WHICH CONTAINED THE IMPLANT INFORMATION. THE PATIENT HAD RECEIVED THREE IMPLANTS OF THE SAME PART AND LOT NUMBER DURING THE 2017 PROCEDURE. THE PARTS WERE AR-1927PSF-45, CORKSCREW SUTURE ANCHORS, LOT 10113577. PATIENT STATES SHE HAS BEEN IN POST OPERATIVE PAIN THAT NEVER WENT AWAY. PATIENT PARTICIPATED IN OVER ONE YEAR OF PHYSICAL THERAPY SO THE MOBILITY IS THERE BUT STILL LIMITED AND PA

  Patient problems: Inflammation; Loss of Range of Motion; Pain; Reaction; Swelling

  MAUDE report 9178714 ↗
• InjurySep 24, 2018Patient-Device Incompatibility

  AN INITIAL CONTACT WAS RECEIVED THROUGH THE ARTHREX WEBSITE REQUESTING A CONTACT PERSON REGARDING POST-OPERATIVE INFECTIONS INVOLVING ARTHREX PRODUCTS. UPON FURTHER INVESTIGATION, IT HAS BEEN DISCOVERED THAT A PATIENT HAD LEFT SHOULDER ARTHROSCOPY-ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2018. DURING THE PROCEDURE, THE FOLLOWING ARTHREX PRODUCTS WERE IMPLANTED: ARTHREX SUTURE ANCHOR PEEK CORKSCREW FT 4.5X14MM X2(AR-1927PSF-45, LOT: F200079 AND LOT: F185845) AND SUTURE ANCHOR PUSHLOCK 3.5X19.5MM X3(AR-1926PS, LOT: 10194738). DURING PATIENT OFFICE VISIT ON (B)(6) 2018, PATIENT REPORTED POSSIBLE REACTION TYPE SYMPTOMS. THE SYMPTOMS INCLUDED: ERYTHEMA, PAIN AND TENDERNESS. THE PATIENT HAS BEEN TREATED WITH PO ANTIBIOTICS, AND SURGERY TO DRAIN SHOULDER AND REMOVE ALL IMPLANTS EXCEPT FOR TWO PUSHLOCK ANCHORS. TESTING HAS BEEN PERFORMED HOWEVER TO DATE ALL CULTURES HAVE BEEN REPORTED AS NEGATIVE, INCLUDING P-ACNES. ADDITIONAL INFORMATION OBTAINED 9/11/2018: THE DATE OF THE SECOND SURGERY TO DRAIN SHOULDER AND REMOVE ALL IMPLANTS EXCEPT FOR TWO PUSHLOCK ANCHORS WAS (B)(6) 2018. THE SURGERY WAS PERFORMED AT A DIFFERENT FACILITY THAN THE ORIGINAL PROCEDURE. THE EXPLANTED ANCHORS ARE REPORTED

  Patient problems: Erythema; Pain; Reaction; Unspecified Infection

  MAUDE report 7902493 ↗
• InjurySep 24, 2018Appropriate Device Problem Term/Code Not Available

  AN INITIAL CONTACT WAS RECEIVED THROUGH THE ARTHREX WEBSITE REQUESTING A CONTACT PERSON REGARDING POST-OPERATIVE INFECTIONS INVOLVING ARTHREX PRODUCTS. UPON FURTHER INVESTIGATION IT HAS BEEN DISCOVERED THAT A PATIENT HAD LEFT SHOULDER ARTHROSCOPY-ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2018. DURING THE PROCEDURE THE FOLLOWING ARTHREX PRODUCTS WERE IMPLANTED: ARTHREX SUTURE ANCHOR PEEK CORKSCREW FT 4.5X14MM X2(AR-1927PSF-45, LOT: F200079 AND LOT: F185845) AND SUTURE ANCHOR PUSHLOCK 3.5X19.5MM X3(AR-1926PS, LOT: 10194738). DURING PATIENT OFFICE VISIT ON (B)(6) 2018 PATIENT REPORTED POSSIBLE REACTION TYPE SYMPTOMS. THE SYMPTOMS INCLUDED: ERYTHEMA, PAIN AND TENDERNESS. THE PATIENT HAS BEEN TREATED WITH PO ANTIBIOTICS, AND SURGERY TO DRAIN SHOULDER AND REMOVE ALL IMPLANTS EXCEPT FOR TWO PUSHLOCK ANCHORS. TESTING HAS BEEN PERFORMED HOWEVER TO DATE ALL CULTURES HAVE BEEN REPORTED AS NEGATIVE, INCLUDING P-ACNES. ADDITIONAL INFORMATION OBTAINED 9/11/2018: THE DATE OF THE SECOND SURGERY TO DRAIN SHOULDER AND REMOVE ALL IMPLANTS EXCEPT FOR TWO PUSHLOCK ANCHORS WAS (B)(6) 2018. THE SURGERY WAS PERFORMED AT A DIFFERENT FACILITY THAN THE ORIGINAL PROCEDURE. THE EXPLANTED ANCHORS ARE REPORTED TO

  Patient problems: Erythema; Hypersensitivity/Allergic reaction; Pain; Unspecified Infection

  MAUDE report 7902474 ↗