Arthrex® AR-1938PSRecalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00888867024229), received between Feb 7, 2018 and Sep 21, 2026 — classified as 2 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Break” (12 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 25 most recent of 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Break

  On 7th September 2026, it was reported by a Distributor via an Email that for 1 unit of AR-1938PS, Suture Anchor, PEEK Suture Tak®, Knotless 3.0 mm x 12.7 mm, its suture was broken during suture passing step.This was detected during a SCR procedure on (b)(6) 2026. The procedure was completed successfully by using additional anchor. There was no patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50843997 ↗
• MalfunctionSep 21, 2026Device Dislodged or Dislocated

  On 7th September 2026, it was reported by a Distributor via an Email that for 1 unit of AR-1938PS, Suture Anchor, PEEK Suture Tak®, Knotless 3.0 mm x 12.7 mm, its anchor was pulled out during suture passing step.This was detected during a Remplissage procedure on (b)(6) 2026. The procedure was completed successfully by using additional SutureTak. There was no patient harm.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50842761 ↗
• MalfunctionJul 27, 2026Material Split, Cut or Torn

  Patient problems: Foreign Body In Patient

  MAUDE report 50011679 ↗
• MalfunctionMay 7, 2026Break

  IT WAS REPORTED THAT DURING A HIP SURGERY THREE ANCHORS BROKE ONE AFTER THE OTHER. FINALLY, THE DOCTOR TIED THE THREAD BY HAND AND SUCCEEDED AFTER TIGHTENING THE THIRD ONE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE THIRD 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 25113356 ↗
• MalfunctionMay 7, 2026Break

  IT WAS REPORTED THAT DURING A HIP SURGERY THREE ANCHORS BROKE ONE AFTER THE OTHER. FINALLY, THE DOCTER TIED THE THREAD BY HAND AND SUCCEEDED AFTER TIGHTENING THE THIRD ONE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE THIRD 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 25113238 ↗
• MalfunctionMay 7, 2026Break

  IT WAS REPORTED THAT DURING A HIP SURGERY THREE ANCHORS BROKE ONE AFTER THE OTHER. FINALLY, THE DOCTER TIED THE THREAD BY HAND AND SUCCEEDED AFTER TIGHTENING THE THIRD ONE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE THIRD 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 25113228 ↗
• MalfunctionMay 27, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT DURING A HIP LABRUM SURGERY, WHEN THE ANCHOR WAS ENTERED (THE 4TH) AND THE SPEAR WAS REMOVED THERE WERE FOUR SUTURES INSTEAD OF THREE. 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 22087855 ↗
• MalfunctionNov 5, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE SUTURE TORE DURING INSERTION. 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 20612373 ↗
• MalfunctionAug 26, 2024Positioning Failure; Material Twisted/Bent; Positioning Failure; Material Twisted/Bent

  ON 08/01/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1938PS KNOTLESS SUTURETAC PULL STITCH WAS BUNCHED UP. THE SUTURE STITCH WAS PASSED THROUGH THE LABRUM. THERE WAS NO LOOP TO PASS THE IMPLANT STITCH THROUGH TO ACHIEVE FINAL FIXATION. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT. CASE COMPLETED BY DRILLING FOR ANOTHER ANCHOR REINSERTING. DELAY IN CASE 8 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20065491 ↗
• MalfunctionJun 25, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROSCOPY THE ANCHOR BROKE OFF IN TWO PARTS OUTSIDE THE JOINT. 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 19603825 ↗
• MalfunctionJun 19, 2024Component Misassembled; Component Misassembled

  ON 1/4/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1938PS SUTURETAK KNOTLESS SPLICE APPEARED TO BE ON THE OUTSIDE OF THE ANCHOR AND THE REPAIR SUTURES COULD NOT PASS THROUGH THE ANCHOR. THIS WAS DISCOVERED DURING A LABRUM REPAIR PROCEDURE ON (B)(6) 2021. SURGEON CUT THE SUTURES OUT AND LEFT THE ANCHOR INSIDE THE PATIENT. THE REPAIR WAS COMPLETED USING AN AR-1923PS PEEK PUSHLOCK WITHOUT FURTHER ISSUES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19567593 ↗
• MalfunctionMay 23, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED ON 8/24/2021 BY A DISTRIBUTOR REP THAT ON (B)(6) 2021 TWO PEEK KNOTLESS SUTURETAK SUTURE ANCHORS WERE BEING USED IN A CASE. DURING USE, BOTH ANCHORS FAILED AND DID NOT WORK. NO FURTHER INFORMATION, ADDITIONAL DETAILS REQUESTED. ADDITIONAL INFORMATION PROVIDED 8/27/2021: PROCEDURE BEING PERFORMED WAS AN ANKLE INSTABILITY REPAIR. THE TUNNEL WAS NOT MADE CORRECTLY PRIOR TO THE INSERTION OF THE ANCHORS SO WHEN PULLING THE SUTURES, THE PLACEMENT OF THE ANCHORS WAS LOOSE. THE TUNNELS WERE PREPARED WITH A SHAVER DRILL FOR 3.0 MM KNOTLESS SUTURETAK, HARD BONE AR 1938DSR. THE PROCEDURE WAS COMPLETED WITH AN AR-1915SNF.

  Patient problems: Insufficient Information

  MAUDE report 19381990 ↗
• MalfunctionMay 21, 2024Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT DURING A HIP SURGERY WHEN THE SURGEON WAS SHUTTELING THE SUTURES, THE ANCHOR CAME OUT OF THE BONE. NO PART OF THE DEVICE BROKE OFF. THE SURGEON DECIDED TO NOT PLACE ANY OTHER ANCHORS AFTER THAT ONE. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19362701 ↗
• MalfunctionMay 14, 2024Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT DURING A SHOULDER RECONSTRUCTION SURGERY NO LOOP OBTAINED WHEN PULLING THE MAIN THREAD OF THE DEVICE. 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 19312504 ↗
• MalfunctionMay 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 12/14/2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-1938PS ANCHOR PULLED OUT DURING A SLAP LABRUM REPAIR. IT WAS REPLACED AND THE SECOND PULLED OUT. A THIRD ONE WAS USED AND THE SAME EVENT OCCURRED. ALL WAS RETRIEVED. THE DOCTOR DRILLED ANOTHER HOLE AND TRIED ANOTHER AR-1938PS WITH A DIFFERENT LOT NUMBER AND THE CASE COMPLETED WITH NO FURTHER ISSUES. THE PATIENT IS FINE TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19281935 ↗
• MalfunctionApr 18, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 1/4/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1938PS SUTURETAK KNOTLESS SPLICE APPEARED TO BE ON THE OUTSIDE OF THE ANCHOR AND THE REPAIR SUTURES COULD NOT PASS THROUGH THE ANCHOR. THIS WAS DISCOVERED DURING A LABRUM REPAIR PROCEDURE ON (B)(6) 2021. SURGEON CUT THE SUTURES OUT AND LEFT THE ANCHOR IN, DRILLED A NEW BONE HOLE AND IMPLANTED ANOTHER AR-1938PS SUTURETAK. HOWEVER, THE SAME OCCURRED WHERE THE KNOTLESS SPLICE WAS ON THE OUTSIDE OF THE ANCHOR AND THE REPAIR SUTURES WERE UNABLE TO PASS THROUGH. AGAIN, SURGEON CUT THE SUTURES AND LEFT ANCHOR IN. A NEW BONE HOLE WAS DRILLED AND ANOTHER AR-1938PS WAS IMPLANTED BUT THE SAME ISSUE OCCURRED. FINALLY, SURGEON USED AN AR-1923PS PEEK PUSHLOCK TO COMPLETE THE REPAIR WITHOUT FURTHER ISSUES.

  Patient problems: Foreign Body In Patient

  MAUDE report 19138281 ↗
• MalfunctionApr 11, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED ON 8/24/2021 BY A DISTRIBUTOR REP THAT ON (B)(6) 2021 TWO PEEK KNOTLESS SUTURE-TAK SUTURE ANCHORS WERE BEING USED IN A CASE. DURING USE, BOTH ANCHORS FAILED AND DID NOT WORK. NO FURTHER INFORMATION, ADDITIONAL DETAILS REQUESTED. ADDITIONAL INFORMATION PROVIDED 8/27/2021: PROCEDURE BEING PERFORMED WAS AN ANKLE INSTABILITY REPAIR. THE TUNNEL WAS NOT MADE CORRECTLY PRIOR TO THE INSERTION OF THE ANCHORS SO WHEN PULLING THE SUTURES, THE PLACEMENT OF THE ANCHORS WAS LOOSE. THE TUNNELS WERE PREPARED WITH A SHAVERDRILL FOR 3.0 MM KNOTLESS SUTURETAK, HARD BONE AR 1938DSR. THE PROCEDURE WAS COMPLETED WITH AN AR-1915SNF.

  Patient problems: Insufficient Information

  MAUDE report 19088838 ↗
• MalfunctionApr 1, 2024Break; Break

  ON 5/27/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1938PS PEEK SUTURE TAK WAS IMPLANTED INTO THE PATIENT AND WHILE TENSIONING, THE SUTURES BROKE. THE SUTURES WERE CUT AND THE ANCHOR PORTION REMAINS IN THE PATIENT. SURGEON OPENED AN AR-2923BC BIOCOMPOSITE PUSHLOCK TO CONTINUE WITH THE REPAIR; HOWEVER, ANCHOR BROKE INSIDE THE PATIENT DURING INSERTION. SURGEON WAS ABLE TO RETRIEVED ALL THE BROKEN FRAGMENTS. ANOTHER AR-2923BC BIOCOMPOSITE PUSHLOCK WAS OPENED AND CASE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING A LABRAL REPAIR ON (B)(6)2022.

  Patient problems: Foreign Body In Patient

  MAUDE report 19012509 ↗
• MalfunctionMar 29, 2024Break; Break

  ON 2/25/2022, IT WAS REPORTED BY AN A SALES REPRESENTATIVE VIA EMAIL THAT A PILOT HOLE WAS DRILLED INTO THE GLENOID USING AN AR-1934DS-2 FROM THE DISPOSABLE KIT. THE ANCHOR WAS PUT IN THROUGH THE DRILL GUIDE AND THE SUTURE WERE PASSED AROUND THE ANTERIOR LABRUM AND THEN SHUTTLED INTO THE ANCHOR. DURING THE SHUTTLING PROCESS THE SHUTTLE SUTURE SNAPPED BEFORE THE REPAIR SUTURE MADE IT INTO THE ANCHOR. SURGEON WAS ABLE TO DRILL THROUGH THE ANCHOR WITH AN AR-1926DS DRILL BIT AND SHUTTLE SUTURETAPE AROUND THE LABRUM AND USE AN AR-1926PS PUSHLOCK ANCHOR TO COMPLETE THE REPAIR. NOTHING WAS LEFT IN THE PATIENT AND THE SURGERY WAS COMPLETED WITHOUT ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 19004260 ↗
• MalfunctionMar 29, 2024Break; Break

  IT WAS REPORTED THAT DURING A SHOULDER STABILISATION SURGERY THE SUTURE SNAPPED ON TENSIONING. 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. UPDATE SWIT 22-FEB-2022: THEY DIDN'T USE ANOTHER ANCHOR IN THAT POSITION AS THE SPACE WAS LIMITED, THEY RELIED ON THE OTHERS. THE ANCHOR REMAINS THERE IN PLACE, BUT WITH NO SUTURES. NO SWITCH IN TECH, JUST RELIED ON OTHER ANCHORS.

  Patient problems: Foreign Body In Patient

  MAUDE report 19003699 ↗
• MalfunctionJan 26, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 1/04/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1938PS KNOTLESS ANCHOR WOULD NOT SEAT INTO THE PATIENT AND THE ANCHOR PULLED OUT. THIS OCCURRED DURING USE IN A CASE AND DELAY IN THE CASE WAS OVER 15 MINUTES. CASE WAS COMPLETED USING ANOTHER COMPANY ANCHOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18589036 ↗
• MalfunctionJan 22, 2024Break; Break

  ON 01/02/2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-1938PS SUTURE ANCHOR WAS BROKEN DURING INSERTION. THE CASE WAS COMPLETED USING ANOTHER AR-1938PS WITH UNKNOWN LOT NUMBERS.

  Patient problems: Insufficient Information

  MAUDE report 18553244 ↗
• MalfunctionOct 24, 2022Break

  IT WAS REPORTED THAT DURING A SHOULDER STABILIZATION 360° SURGERY THE SUTURE OF THE DEVICE SNAPPED AT KNOTLESS SPLICE DURING FINAL TENSIONING, BEFORE DESIRED TENSION WAS ACHIEVED. SHUTTLING WAS PERFORMED GENTLY USING TWO CANNULAS. THE DAMAGED SUTURE WAS RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY. UPDATE (B)(6) 2022. IT WAS CONFIRMED THAT THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME 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 15657691 ↗
• MalfunctionJan 11, 2022Break; Entrapment of Device

  ON (B)(6) 2021, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-1938PS SUTURETAK PEEK ANCHOR BROKE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2021. WHEN SURGEON IMPACTED THE INSERTER UP TO THE LAST LASER MARK, ANCHOR BROKE. AFTER RECEIVING ADDITIONAL INFORMATION ON 12/22/2021, DISTRIBUTOR HAS CONFIRMED THAT THIS OCCURRED DURING AN ANKLE INSTABILITY PROCEDURE AND THE BROKEN ANCHOR WAS NOT RETRIEVED FROM INSIDE THE PATIENT. CASE WAS COMPLETED USING A PRODUCT FROM ANOTHER MANUFACTURER.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 13225383 ↗
• MalfunctionOct 12, 2021Break

  ON (B)(6) 2021 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT DURING A HIP SCOPE PROCEDURE THAT TWO AR-1938PS SUTURE ANCHORS BROKE IN HALF DURING THE INSERTION. ALL WAS RETRIEVED. THEY WERE REPLACED WITH A NON-ARTHREX PRODUCT AND THE CASE WAS COMPLETED WITH NO FURTHER ISSUES. THE PATIENT IS FINE TO DATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12615368 ↗