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

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00888867237872), received between Mar 29, 2018 and Mar 4, 2025 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 4, 2025Break; Break

  ON 2/19/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1927PST-475 PEEK CORKSCREW FT BROKE DURING INSERTION. THE ANCHOR BROKE WITH THREE THREADS REMAINING, NOT IN THE BONE. THE REST OF THE ANCHOR REMAINED INTACT AND WAS INSERTER UNTIL THE LOOP HOLDING THE 1.3 MM SUTURES WAS BURIED BELOW THE LEVEL OF THE BONE. THE THREADS WERE THEN REMOVED BUT HAD BROKEN INTO SMALLER PIECES. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION REQUESTED ON 2/26/2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21517599 ↗
• MalfunctionJun 7, 2024Difficult to Insert; Difficult to Insert

  IT WAS REPORTED DURING A ROTATOR CUFF REPAIR PROCEDURE, THE SURGEON INSERTED THE AR-1927PST-475 LOT: 10272121 INTO THE HUMERUS, THE SURGEON DOUBLE TAPPED AND THE SUTURE ANCHOR WOULD NOT SEAT. THE CASE WAS COMPLETED USING A DIFFERENT AR-1927PST-475 LOT: 12649025.

  Patient problems: Insufficient Information

  MAUDE report 19484047 ↗
• MalfunctionMay 3, 2024Break; Break

  ON 04/11/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT TWO AR-1927PST-475 PEEK CORKSCREW FT ANCHORS BROKE DURING INSERTION. THE SURGEON DID NOT TAP. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 19240135 ↗
• MalfunctionMay 3, 2024Break; Break

  ON 04/11/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT TWO AR-1927PST-475 PEEK CORKSCREW FT ANCHORS BROKE DURING INSERTION. THE SURGEON DID NOT TAP. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 19239967 ↗
• MalfunctionApr 17, 2024Defective Device; Defective Device

  ON 03/30/2022, IT WAS REPORTED BY A DISTRIBUTOR VIA PHONE THAT A AR-1927PST-475 SUTURE ANCHOR APPEARED TO BE ABNORMAL. THIS WAS DISCOVERED ON (B)(6) 2022 DURING A ROTATOR CUFF REPAIR WHEN THE SURGEON FELT AN AREA OF THE DEVICE LOOKED ABNORMAL AND WANTED TO BE SURE THERE WAS NO ISSUE WITH THE SUTURES THAT WERE USED. THE DISTRIBUTOR OPENED UP ANOTHER AR-1927PST-475 SUTURE ANCHOR TO DEMONSTRATE TO THE SURGEON THAT EVERYTHING WAS NORMAL WITH THE DEVICE. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19127164 ↗
• MalfunctionJan 22, 2024Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1927PST-475 PEEK CORKSCREW FT ANCHOR BROKE DURING INSERTION. THE CASE WAS COMPLETED USING ANOTHER AR-1927PST-475 PEEK CORKSCREW FT. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2023. THE PATIENT WAS NOT HARMED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18551997 ↗
• MalfunctionSep 1, 2023Break; Break

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1927PST-475 PEEK CORKSCREW FT BROKE UPON INSERTING INTO THE BONE SOCKET. THE BROKEN FRAGMENTS WERE RETRIEVED, AND THE CASE WAS COMPLETED USING ANOTHER AR-1927PST-475 PEEK CORKSCREW FT. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 8/8/2023: THIS WAS DISCOVERED DURING AN RCR PROCEDURE, AND THERE WAS ONLY A BRIEF DELAY; THE PATIENT WAS NOT HARMED.

  Patient problems: Failure of Implant

  MAUDE report 17669925 ↗
• MalfunctionJul 6, 2023Material Fragmentation; Material Fragmentation

  ON (B)(6) 2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (3) AR-1927PST-475 PEEK CORKSCREW FT ANCHORS BROKE AND SHRED APART DURING INSERTION. THE ANCHORS WERE ONLY INSERTER ABOUT ONE-FOURTH OF THE WAY BEFORE THEY BEGAN TO BREAK. THIS WAS DISCOVERED DURING A REMPLISSAGE PROCEDURE ON (B)(6)2023. ADDITIONAL INFORMATION REQUESTED.

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

  MAUDE report 17268141 ↗
• MalfunctionNov 21, 2022Break

  ON 11/1/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1927PST-475 PEEK CORKSCREW ANCHOR BODY DEFORMED UPON INSERTION. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED ON 11/1/2022: SALES REPRESENTATIVE STATED THAT AS THE AR-1927PST-475 PEEK CORKSCREW WAS BEING INSERTED, IT PEELED AND THEN SNAPPED. ALL FRAGMENTS WERE RETRIEVED, AND CASE WAS COMPLETE USING ANOTHER AR-1927PST-475 PEEK CORKSCREW. THIS WAS DISCOVERED DURING AN RCR PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15834785 ↗
• MalfunctionApr 18, 2022Break

  (B)(6) 2022. IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1927PST-475 PEEK CORKSCREW SUTURE ANCHOR BROKE INTO PIECES AS SURGEON WAS THREADING IT INTO THE BONE. ALL THE FRAGMENTS WERE REMOVED FROM INSIDE THE PATIENT AND ANOTHER ANCHOR WAS PLACED IN THE SAME BONE HOLE SUCCESSFULLY. HOWEVER, THIS ANCHOR ALSO CRUMBLED INTO PIECES WHEN THREADED INTO THE BONE. ALL FRAGMENT WERE REMOVED AND ANOTHER ANCHOR WAS USED IN ITS PLACE AND CASE WAS COMPLETED SUCCESSFULLY. BOTH ANCHORS THAT BROKE WERE FROM THE SAME LOT NUMBER. THIS WAS DISCOVERED DURING A RCR (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14135398 ↗
• MalfunctionNov 8, 2021Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF SHOULDER SURGERY THE DEVICE BROKE INSIDE THE PATIENT. THE BREAKAGE OCCURRED AT THE TRANSITION BETWEEN THE FENESTRATED PART AND THE CLOSED PART OF THE ANCHOR. NO BROKEN PARTS REMAINED INSIDE THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12770436 ↗
• MalfunctionOct 13, 2021Break

  ON (B)(6) 2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1927PST-475 SUTURE ANCHOR IS BROKEN AND COULD NOT BE USED. THE SURGEON FOLLOWED THE CORRECT PROCEDURES IN ORDER TO INSERT THE CORKSCREW. IT WAS SAFELY REMOVED AND SAVED TO BE RETURNED BACK TO ARTHREX. THE PATIENT WAS NOT HARMED DURING THE INSERTION OR REMOVAL OF THE DEVICE. THIS WAS DISCOVERED DURING USE. ADDITIONAL INFORMATION PROVIDED ON 09/09/2021 THE PROCEDURE WAS AN ARTHROSCOPIC RTC REPAIR. THE DEVICE BROKE UPON INSERTION, AFTER PREPARING A PROPER BONE SOCKET. THE BROKEN DEVICE WAS RETRIEVED AND THEN ANOTHER DEVICE WAS INSERTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12623351 ↗
• InjuryMar 29, 2018Device Slipped

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR WHILE IMPLANTING THE DEVICE; THE SURGEON TAPPED AND PUNCHED AS HE WAS SUPPOSED TO AND THE ANCHOR BODY COLLAPSED. THE SUTURE EYELET CAME OUT OF THE ANCHOR BODY AND THE DISTAL END COLLAPSED COMPLETELY. THE ANCHOR HELD ON TO THE EYELET BUT THE DISTAL END SHATTERED. SURGEON TESTED TO MAKE SURE IT WAS GOING TO HOLD AND IT DID. SURGEON THEN PASSED THE SUTURE THROUGH THE CUFF AND IT HELD AND THEN PROCEEDED AS NORMAL. THEN PROCEEDED AND IMPLANTED A LATERAL ANCHOR. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE QUALITY OF THE BONE WAS HARD. FOLLOW-UP INVESTIGATION: THE DISTAL END OF THE CORKSCREW ANCHOR HAD COLLAPSED/COMPRESSED. WHEN THIS OCCURRED THE EYELET BECAME SLIGHTLY LOOSE BUT REMAINED ATTACHED TO THE ANCHOR. THE SURGEON CHOSE TO LEAVE THE WHOLE ANCHOR WITH THE COLLAPSED/COMPRESSED DISTAL END IN PLACE SINCE IT WAS HOLDING TIGHT AND CONTINUED TO COMPLETE THE PROCEDURE WITH THIS CORKSCREW ANCHOR. NO ADDITIONAL UNPLANNED INCISIONS OR ANCHORS WERE NEEDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7380853 ↗