Arthrex® AR-1941PSRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888867270794), received between Jun 27, 2019 and May 24, 2024 — classified as 4 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 24, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT THE ANCHOR FROM THE AR-3638DS AND THE AR-3638 WOULD NOT SEAT. THEY ATTEMPTED WITH AN AR-1941PS WHICH WOULD NOT SEAT. THEY COMPLETED THE CASE (LATERAL EPICONDYLE) WAS ANOTHER AR-1941PS.

  Patient problems: Insufficient Information

  MAUDE report 19392270 ↗
• MalfunctionMay 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 11/23/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (2) AR-1938PSS PEEK KNOTLESS SUTURETAK ANCHOR AND AN AR-1941PS PEEK KNOTLESS CORKSCREW ANCHOR, PULLED OUT FROM IMPLANTATION SITE. THIS WAS DISCOVERED DURING AN MPFL RECONSTRUCTION PROCEDURE ON (B)(6) 2021. WHEN SURGEON IMPLANTED BOTH SUTURETAK, THE ANCHORS PULLED OUT WITHOUT ANY RESISTANCE. THEN, SURGEON REMOVED THE SUTURETAK ANCHORS AND SWAPPED IT FOR THE CORKSCREW ANCHOR BUT IT ALSO PULLED OUT WITHOUT RESISTANCE. FINALLY, THE SURGEON HAD TO DRILL A BONE TUNNEL TO ACHIEVE ADEQUATE FIXATION AND COMPLETE CASE. AFTER RECEIVING ADDITIONAL INFORMATION ON 11/30/2021, SALES REPRESENTATIVE HAS CONFIRMED THAT ALL THREE FAILED ANCHORS WERE REMOVED FROM THE PATIENT AND THERE WAS NOT BROKEN PIECES LEFT TO RETRIEVED. SURGEON COMPLETED PROCEDURE SUCCESSFULLY AND PATIENT WAS NOT AFFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19286067 ↗
• MalfunctionMar 7, 2024Material Deformation; Material Deformation

  ON 02/22/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1941PS KNOTLESS CORKSCREW INSERTER WAS STRIPPING THE INSIDE OF THE ANCHOR AND THE ANCHOR WOULD NOT BITE TO BE INSERTED. CASE COMPLETED USING ANOTHER CORKSCREW. 3-MINUTE DELAY. THIS OCCURRED DURING USE IN A CASE WITH NO PATIENT EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18859034 ↗
• MalfunctionJul 26, 2023Break; Break

  ON (B)(6)2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-1941PS PEEK KNOTLESS CORKSCREW ANCHOR PULLED OUT. THE PEEK KNOTLESS CORKSCREW WAS INSERTED INTO THE LATERAL EPICONDYLE AND THE BONE WAS PREPPED USING AN AR-1941DS INSTRUMENT KIT IN STANDARD FASHION. THE ANCHOR WAS INSERTED WITH NO PROBLEM, BUT IT PULLED OUT WHEN SHUTTLING THE REPAIR STITCH THROUGH THE KNOTLESS MECHANISM. THIS WAS DISCOVERED DURING AN ECRB DEBRIDEMENT AND REPAIR PROCEDURE ON(B)(6)2023. ADDITIONAL INFORMATION RECEIVED ON (B)(6)2023: THE CASE WAS COMPLETED USING AN AR-3636 KNOTLESS FIBERTAK.

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

  MAUDE report 17395395 ↗
• MalfunctionApr 27, 2021Break

  IT WAS REPORTED AFTER THE KNOTLESS SUTURETAK MALFUNCTIONED, THE SURGEON DECIDED TO UPSIZE TO THE AR-1941PS 3.9 KNOTLESS CORKSCREW TO FINISH THAT PORTION OF THE REPAIR. THE SURGEON USED THE AR-1941D TO DILATE THE SOCKET, BUT THE ANCHOR BROKE IMMEDIATELY UPON INSERTION. THE SURGEON WAS ABLE TO PICK OUT THE LOOSE PIECES USING A GRASPER AND A SHAVER. NO PIECE FROM THE UNSUCCESSFUL ANCHOR WAS LEFT IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 11730921 ↗
• InjuryJun 16, 2020Break; Failure to Advance; Positioning Problem

  IT WAS REPORTED THAT THE AR-1941PS, 3.9 CORKSCREW ANCHOR (S704108), WAS UNABLE TO BE FULLY IMPLANTED. THE SCREW DRIVER STRIPPED THE ANCHOR CAUSING IT TO NOT BE ABLE TO BE ADVANCED TO A SEATED POSITION AND WAS NOT ABLE TO BE REMOVED. THE ANCHOR NEEDED TO BE BURRED DOWN AND ANOTHER ANCHOR WAS PUT IN IT'S PLACE. INITIAL REPORT ALSO STATED THAT NO PART OF THE IMPLANT WAS LEFT IN THE PATIENT. SURGEON HAS EXPERIENCE USING THE DEVICE. THERE IS NO DEVICE TO RETURN. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION PROVIDED 6/1/2020: THE PROCEDURE WAS A RWMPLISSAGE. A 3.9 PUNCH WAS USED TO PREPARE THE BONE. THE BONE QUALITY WAS AVERAGE AND ACCEPTABLE FOR USE OF A PUNCH VS. A DRILL. THE ANCHOR WAS PARTIALLY REMOVED. THE BOTTOM HALF WAS LEFT IN THE PATIENT AND NOT ABLE TO BE REMOVED. THE TOP HALF OF THE ANCHOR WAS BURRED OFF. THE SALES REP HAS CONFIRMED THAT THE NEW ANCHOR WAS A 3.9 SUTURETAK WHICH WAS PLACED NEXT TO THE ORIGINAL 3.9 CORKSCREW ANCHOR.

  Patient problems: No Code Available

  MAUDE report 10159959 ↗
• InjuryOct 11, 2019Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A ROTATOR CUFF REPAIR PROCEDURE (DATE OF SURGERY CURRENTLY UNKNOWN). THE PATIENT RE-TORE THEIR ROTATOR CUFF AND HAD A REVISION RCR ON (B)(6) 2019. DURING THE REVISION IT WAS DISCOVERED THAT THE PATIENT'S CUFF WAS IRREPARABLE AND THE SURGEON SWITCHED TO A SUPERIOR CAPSULE RECONSTRUCTION. DUE TO THE SOFT BONE QUALITY THE FOLLOWING ARTHREX PARTS BEING USED WOULD NOT STAY SEATED IN THE BONE: AR-1938BC // LOT: 10265961 // QTY.: 1, AR-1938BC // LOT: F189852 // QTY.: 1. THE REP STATED THE PROCEDURE WAS ARTHROSCOPIC. IT IS UNKNOWN IF ARTHREX PARTS WERE USED DURING THE ORIGINAL RCR; HOWEVER, NO ARTHREX PRODUCTS WERE REMOVED DURING THE REVISION ON (B)(6) 2019. THE REP STATED THERE WERE NO FURTHER ISSUES WITH ANY OTHER ARTHREX PRODUCTS DURING THE CASE. THE HUSBAND OF THE PATIENT CALLED THE SURGEON ON (B)(6) 2019, STATING THE LATERAL PORTAL WOUND WAS DRAINING FLUID AND THEY WERE WORRIED ABOUT INFECTION. THE PATIENT CAME IN FOR A FOLLOW-UP VISIT WITH THE SURGEON ON (B)(6) 2019 TO HAVE THE WOUND LOOKED AT. THE REP STATED THEY CANNOT CONFIRM IF CULTURES WERE TAKEN. AT THE MOMENT NO REVISION PROCEDURE IS SCHEDULED, BUT THE PATIENT HAS BEEN SCHEDULED TO CO

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 9179265 ↗
• InjuryOct 11, 2019Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A ROTATOR CUFF REPAIR PROCEDURE (DATE OF SURGERY CURRENTLY UNKNOWN). THE PATIENT RE-TORE THEIR ROTATOR CUFF AND HAD A REVISION RCR ON (B)(6) 2019. DURING THE REVISION IT WAS DISCOVERED THAT THE PATIENT'S CUFF WAS IRREPARABLE AND THE SURGEON SWITCHED TO A SUPERIOR CAPSULE RECONSTRUCTION. DUE TO THE SOFT BONE QUALITY THE FOLLOWING ARTHREX PARTS BEING USED WOULD NOT STAY SEATED IN THE BONE: AR-1938BC // LOT: 10265961 // QTY.: 1, AR-1938BC // LOT: F189852 // QTY.: 1. THE REP STATED THE PROCEDURE WAS ARTHROSCOPIC. IT IS UNKNOWN IF ARTHREX PARTS WERE USED DURING THE ORIGINAL RCR; HOWEVER, NO ARTHREX PRODUCTS WERE REMOVED DURING THE REVISION ON (B)(6) 2019. THE REP STATED THERE WERE NO FURTHER ISSUES WITH ANY OTHER ARTHREX PRODUCTS DURING THE CASE. THE HUSBAND OF THE PATIENT CALLED THE SURGEON ON (B)(6) 2019, STATING THE LATERAL PORTAL WOUND WAS DRAINING FLUID AND THEY WERE WORRIED ABOUT INFECTION. THE PATIENT CAME IN FOR A FOLLOW-UP VISIT WITH THE SURGEON ON (B)(6) 2019 TO HAVE THE WOUND LOOKED AT. THE REP STATED THEY CANNOT CONFIRM IF CULTURES WERE TAKEN. AT THE MOMENT NO REVISION PROCEDURE IS SCHEDULED, BUT THE PATIENT HAS BEEN SCHEDULED TO CO

  Patient problems: Fluid Discharge

  MAUDE report 9179207 ↗
• InjuryJun 27, 2019Detachment of Device or Device Component; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A SUPERIOR CAPSULE REPAIR (SCR) WITH FOUR ANCHORS THE THREADS TORE OFF. TWO ANCHORS WERE LEFT IN THE PATIENT AND TWO WERE REMOVED FROM THE PATIENT. IN ORDER TO REMOVE THE ANCHORS, THE SURGEON NEEDED TO CHANGE THE SURGICAL TECHNIQUE TO AN OPEN PROCEDURE. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO DO A SECOND SURGERY. UPDATE 21-JUN-2019: THE ANCHORS LEFT IN THE PATIENT ARE REPORTED TO BE FIXED AND CANNOT MOVE. NO FURTHER ANCHORS WERE PUT ON IT. IT WAS ALSO REPORTED THAT NO CONSEQUENCES ARE EXPECTED FOR THE PATIENT. AN ADDITIONAL CUT WAS MADE TO BETTER ACCESS THE SURGICAL AREA.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8739514 ↗