Arthrex® AR-1923PSRecalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00888867023147), received between May 30, 2019 and Sep 17, 2026 — classified as 9 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Break” (21 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 17, 2026Device Dislodged or Dislocated

  Patient problems: Insufficient Information

  MAUDE report 50801563 ↗
• MalfunctionSep 17, 2026Break

  On 08-Sep-2026, an Arthrex subsidiary employee reported via email that an AR-1923PS Suture Anchor, PEEK PushLock (2.9 mm x 15.5 mm), experienced an issue during an ankle procedure performed on 02-Sep-2026. A #2 FiberWire was passed using a SutureLasso and secured with a PushLock anchor. During fixation assessment, the anchor appeared secure; however, the sutures did not provide the expected fixation. Further evaluation revealed that the tip of the anchor had broken off while the sutures remained within the anchor hole.A second anchor was implanted; however, adequate suture fixation was again not achieved. The sutures were re-passed using a SutureLasso, and during fixation it was observed that the anchor had shifted out of position. The anchor was completely removed with the suture intact.The anchor site was re-prepared, and another anchor was implanted. The sutures were again passed using a SutureLasso, and adequate final fixation was confirmed. The procedure was completed successfully. Due to the complication encountered during the procedure, an additional dose of anesthesia was administered.

  Patient problems: Insufficient Information

  MAUDE report 50801389 ↗
• MalfunctionMar 19, 2026Break

  IT WAS REPORTED THAT DURING A LABRUM REFIXATION SURGERY THE PUSHLOCK BROKE DURING SUTURE LOADING. THE BROKEN PART WAS RETRIEVED FROM THE PATIENT. 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 24638482 ↗
• MalfunctionSep 3, 2025Break; Break

  ON 14TH AUGUST 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA EMAIL THAT FOR 1 UNIT OF AR-1923PS, SUTURE ANCHOR, PEEK PUSHLOCK® 2.9 X 15.5 MM, ITS ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A REPAIR OF THE LATERAL LIGAMENT OF THE ANKLE JOINT SURGERY ON (B)(6) 2025. THE CASE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1923PS. THERE WAS NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22952858 ↗
• MalfunctionJun 20, 2025Break; Break

  ON 02 JUN 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1923PS SUTURE ANCHOR, PEEK PUSHLOCK® 2.9 X 15.5 MM, BROKE DURING USE. THERE ARE 5 UNITS OF THE SAME PRODUCT IN THE PACK. THE DOCTOR USED A NEW UNIT FROM THE SAME PACK AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS WAS DISCOVERED DURING RIGHT SHOULDER ARTHROSCOPIC LABRAL REPAIR AND CAPSULAR RELEASE, MANIPULATION UNDER ANESTHESIA PROCEDURE.

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

  MAUDE report 22298521 ↗
• MalfunctionMar 27, 2025Break; Break

  ON 11TH MARCH 2025, IT WAS REPORTED BY A SALES REP VIA EMAIL THAT FOR 3 UNITS OF AR-1923PS, SUTURE ANCHOR, PEEK PUSHLOCK® 2.9 X 15.5 MM, ON INSERTION OF PUSHLOCK, THE ANCHOR CRUMBLED UP THE INSERTER. THIS HAPPENED FOR ALL THREE UNITS IN THE SAME BATCH. THIS WAS DETECTED DURING USE IN A SHOULDER STABILIZATION PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THEY USED A DIFFERENT BATCH OF PUSHLOCK. 13TH MARCH 2025 - FURTHER INFORMATION PROVIDED FROM THE SALES REP, AFTER TALKING TO THE SURGEON THAT ONE ANCHOR BROKE WHILE INSERTING INTO THE DRILLED HOLE AND PIECES WERE RETRIEVED BY THE SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21707793 ↗
• MalfunctionMar 20, 2025Break; Break

  ON 11TH MARCH 2025, IT WAS REPORTED BY A SALES REP VIA EMAIL THAT FOR 3 UNITS OF AR-1923PS, SUTURE ANCHOR, PEEK PUSHLOCK® 2.9 X 15.5 MM, ON INSERTION OF PUSHLOCK, THE ANCHOR CRUMBLED UP THE INSERTER. THIS HAPPENED FOR ALL THREE UNITS IN THE SAME BATCH. THIS WAS DETECTED DURING USE IN A SHOULDER STABILIZATION PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THEY USED A DIFFERENT BATCH OF PUSHLOCK. ON 13TH MARCH 2025 - FURTHER INFORMATION PROVIDED FROM THE SALES REP, AFTER TALKING TO THE SURGEON THAT ONE ANCHOR BROKE WHILE INSERTING INTO THE DRILLED HOLE AND PIECES WERE RETRIEVED BY THE SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21651690 ↗
• MalfunctionMar 20, 2025Break; Break

  ON 11TH MARCH 2025, IT WAS REPORTED BY A SALES REP VIA EMAIL THAT FOR 3 UNITS OF AR-1923PS, SUTURE ANCHOR, PEEK PUSHLOCK® 2.9 X 15.5 MM, ON INSERTION OF PUSHLOCK, THE ANCHOR CRUMBLED UP THE INSERTER. THIS HAPPENED FOR ALL THREE UNITS IN THE SAME BATCH. THIS WAS DETECTED DURING USE IN A SHOULDER STABILIZATION PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THEY USED A DIFFERENT BATCH OF PUSHLOCK. 13TH MARCH 2025: FURTHER INFORMATION PROVIDED FROM THE SALES REP, AFTER TALKING TO THE SURGEON THAT ONE ANCHOR BROKE WHILE INSERTING INTO THE DRILLED HOLE AND PIECES WERE RETRIEVED BY THE SURGEON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21651631 ↗
• MalfunctionFeb 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 16TH JANUARY 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-1923PS, SUTURE ANCHOR, PEEK PUSHLOCK® 2.9 X 15.5 MM, THE ANCHOR FELL OFF DURING INSERTION. THIS WAS DETECTED DURING AN ANKLE LIGAMENT REPAIR SURGERY ON (B)(6) 2025. AN AR-1923D AND AR-1949 WAS USED TO PREPARE BONE SOCKET AND THE ANCHOR FELL OFF DURING INSERTION. THE PATIENT BONE QUALITY WAS OBSERVED TO BE NORMAL AND NO FRAGMENTS WERE LEFT IN THE PATIENT. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED BY USING ANOTHER NEW AR-1923PS INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21313647 ↗
• MalfunctionDec 31, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC LABRAL RECONSTRUCTION SURGERY ONE OF THE TIP'S OF THE PUSHLOCKER ANCHORS AR-2324PSLC (LOT: 15136825) AND AR-1923PS (LOT: 15236451 & 15151614) BROKE AND BECAME EMBEDDED IN PATIENTS SHOULDER. SURGEON CHECKED FROM ANOTHER PORTAL AND ATTEMPTED TO RETRIEVE THE BROKEN OFF PART USING A GRASPER WHICH WAS NOT POSSIBLE AND THERE WAS A GREATER RISK TO REMOVE THE TIP. THE FRAGMENT REMAINED IN SIDE THE PATIENT. NO FURTHER IN FORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient; Foreign Body Reaction

  MAUDE report 21048550 ↗
• MalfunctionDec 31, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC LABRAL RECONSTRUCTION SURGERY ONE OF THE TIP'S OF THE PUSHLOCKER ANCHORS AR-2324PSLC (LOT: 15136825) AND AR-1923PS (LOT: 15236451 & 15151614) BROKE AND BECAME EMBEDDED IN PATIENTS SHOULDER. SURGEON CHECKED FROM ANOTHER PORTAL AND ATTEMPTED TO RETRIEVE THE BROKEN OFF PART USING A GRASPER WHICH WAS NOT POSSIBLE AND THERE WAS A GREATER RISK TO REMOVE THE TIP. THE FRAGMENT REMAINED IN SIDE THE PATIENT. NO FURTHER IN FORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21048526 ↗
• MalfunctionSep 17, 2024Break; Break

  IT WAS REPORTED THAT DURING A LABRAL REPAIR SURGERY THE ANCHOR WAS INSERTED INTO THE PATIENT WITH A LABRAL TAPE IN THE EYELET. THE EYELET AND THE SCREW CAME LOOSE FROM THE ANCHOR BEFORE DEPLOYMENT. THE SURGEON COULD NOT FIND THE EYELET AND THE SCREW. THE DEVICE REMAINED IN THE PATIENT. 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 20241637 ↗
• MalfunctionMay 10, 2024Difficult to Remove; Difficult to Remove

  ON (B)(6) 2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT TWO AR-1923PS PEEK PUSHLOCK HANDLES COULD NOT BE PULLED OUT BY ROTATING THEM. THE SURGEON HAD TO PULL THEM OUT WITH A HARD HAMMER FORCIBLY. BOTH ANCHORS' BODIES FELL OFF INSIDE THE GLENOHUMERAL JOINT AND WERE RECOVERED USING A DOUBLE-TOOTH PLANER KNIFE. THE CASE WAS COMPLETED USING TWO ADDITIONAL AR-1923PS PEEK PUSHLOCK. THIS WAS DISCOVERED DURING A SHOULDER DISLOCATION PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 4/22/2023: NO ADDITIONAL INCISION WAS MADE TO REMOVE THE BROKEN FRAGMENTS. THE CASE WAS NO DELAYED AND ADDITIONAL ANESTHESIA WAS UNNECESSARY.

  Patient problems: Foreign Body In Patient

  MAUDE report 19294034 ↗
• MalfunctionMay 10, 2024Difficult to Remove; Difficult to Remove

  ON 04/15/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT TWO AR-1923PS PEEK PUSHLOCK HANDLES COULD NOT BE PULLED OUT BY ROTATING THEM. THE SURGEON HAD TO PULL THEM OUT WITH A HARD HAMMER FORCIBLY. BOTH ANCHORS' BODIES FELL OFF INSIDE THE GLENOHUMERAL JOINT AND WERE RECOVERED USING A DOUBLE-TOOTH PLANER KNIFE. THE CASE WAS COMPLETED USING TWO ADDITIONAL AR-1923PS PEEK PUSHLOCK. THIS WAS DISCOVERED DURING A SHOULDER DISLOCATION PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 4/22/2023: NO ADDITIONAL INCISION WAS MADE TO REMOVE THE BROKEN FRAGMENTS. THE CASE WAS NO DELAYED AND ADDITIONAL ANESTHESIA WAS UNNECESSARY.

  Patient problems: Foreign Body In Patient

  MAUDE report 19294004 ↗
• MalfunctionMay 9, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A LABRUM REFIXATION SHOULDER SURGERY THE THREAD LOST CONTACT WITH THE ANCHOR AND MOVED DEEPER INTO THE ANCHOR ALTHOUGH THE APPLIED IMPACT FORCE WAS CONTROLLED. THIS CAUSED THE THICKER PART OF THE ROD TO MOVE INTO THE ANCHOR AND SPREAD IT OPEN. THE ROUND METALLIC IMPACT PLATE WITH APPROX. 1 CM DIAMETER HAD NO STABLE CONNECTION TO THE ROD OR TUBE. NO PART OF THE DEVICE BROKE. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE TWO AFFECTED DEVICES, ALTHOUGH THESE WERE DAMAGED. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19276929 ↗
• MalfunctionDec 18, 2023Break; Break

  ON 11/20/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1923PS PUSHLOCK TIP BROKE OFF WHEN THE SUTURE WAS LOADED. THIS WAS DISCOVERED DURING USE IN A CASE WITH NO PATIENT EFFECT. BROKE OUTSIDE THE PATIENT. CASE COMPLETED USING NEW PUSHLOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18351998 ↗
• MalfunctionNov 20, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 10/27/2023, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT (2) AR-1923PS PEEK PUSHLOCK EYELET AND SUTURES CAME OFF. THE ANCHOR IS IMPACTED THROUGH IT TO THE FIRST LASER LINE WITH ITS PROTECTOR AND THEN ITS ORANGE PROTECTOR IS REMOVED TO BE IMPACTED TO THE SECOND LASER LINE. IT IS REMOVED COUNTERCLOCKWISE TO CUT THE SUTURES SUBSEQUENTLY. THEY WERE PLACED WELL, BUT WHEN THE SUTURES WERE CUT, THE PEEK EYELET WITH THE SUTURES CAME AWAY, LEAVING THE IMPLANT BEHIND. THIS WAS DISCOVERED DURING A SHOULDER INSTABILITY PROCEDURE ON 10/27/2023. THE CASE WAS COMPLETED USING TWO ADDITIONAL AR-1923PS PEEK PUSHLOCK.

  Patient problems: Insufficient Information

  MAUDE report 18172549 ↗
• MalfunctionOct 10, 2023Break; Break

  ON 9/12/2023, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT AN AR-1923PS PEEK PUSHLOCK ANCHOR BROKE INSIDE THE PATIENT. THE SURGEON WAS UNABLE TO RETRIEVE ALL THE BROKEN FRAGMENTS. THIS WAS DISCOVERED DURING A SURGICAL REPAIR PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 17908389 ↗
• MalfunctionSep 19, 2023Break; Break

  ON 08/24/2023, AN FDA MAUDE NOTIFICATION WAS RECEIVED VIA EMAIL. AN UNKNOWN FACILITY REPRESENTATIVE REPORTED THAT AN AR-1923PS PEEK PUSHLOCK ANCHOR BROKE INSIDE THE PATIENT; THE BROKEN FRAGMENTS WERE NOT RETRIEVED. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023.

  Patient problems: Foreign Body In Patient

  MAUDE report 17775403 ↗
• InjuryFeb 16, 2023Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE TIP OF MULTIPLE ANCHORS KEPT BREAKING WHERE THE TAPE WAS INSERTED. DUE TO THIS FAILURE THE PLANNED SURGERY HAD TO BE ABORTED AND AN ADDITIONAL SURGERY WILL BE SCHEDULED.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16385408 ↗
• InjuryFeb 16, 2023Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE TIP OF MULTIPLE ANCHORS KEPT BREAKING WHERE THE TAPE WAS INSERTED. DUE TO THIS FAILURE THE PLANNED SURGERY HAD TO BE ABORTED AND AN ADDITIONAL SURGERY WILL BE SCHEDULED.

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

  MAUDE report 16385385 ↗
• InjuryFeb 16, 2023Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE TIP OF MULTIPLE ANCHORS KEPT BREAKING WHERE THE TAPE WAS INSERTED. DUE TO THIS FAILURE THE PLANNED SURGERY HAD TO BE ABORTED AND AN ADDITIONAL SURGERY WILL BE SCHEDULED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 16385199 ↗
• MalfunctionSep 6, 2022Break; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A STABILIZATION SURGERY 2 DEVICES (AR- 1923PS) WITH SAME LOT NUMBER: (14604052) WERE USED. WHEN PUTTING LABRAL TAPE THROUGH THE EYELET, IT WAS BENDING THE METAL TIP AND THE EYELETS SNAPPED OFF. ALL BROKEN PARTS WERE RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICES WITH THE SAME PART NUMBER BUT DIFFERENT LOT NUMBERS. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15362382 ↗
• MalfunctionJul 11, 2022Contamination; Packaging Problem

  IT WAS REPORTED THAT THE PACKAGING WAS COVERED WITH BLOODSTAINS. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THIS WAS NOTICED DURING INSPECTION. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14976783 ↗
• MalfunctionMay 23, 2022Break

  ON 5/3/2022, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-1923PS PEEK PUSHLOCK ANCHOR TIP BROKE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 14468650 ↗