Arthrex® AR-1934PSRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867024168), received between Jan 19, 2018 and Dec 31, 2025 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 31, 2025Positioning Failure; Use of Device Problem; Positioning Failure; Use of Device Problem

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-1934PS PEEK SUTURE TAK SUTURE ANCHOR WAS WEAK. IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE, THE PEEK SUTURETAK ANCHOR WAS PRESENTED WHEN OPENING THE TIP OF THE DISSECTOR THAT PROTRUDED FROM THE SHAFT AND AN ATTEMPT WAS MADE TO INSERT IT, BUT IT WAS NOT POSSIBLE. THE CASE WAS COMPLETED WITH ANOTHER ANCHOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 23933288 ↗
• MalfunctionApr 21, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 04/03/2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(6) THAT AN AR-1934PS SUTURE ANCHORS SUTURES BECAME LOOSE. THIS OCCURRED DURING USE WHEN FIXING THE SUTURETAK ANCHOR, THE PEEK SCREW REMAINED IN PLACE AND THE SUTURES COME LOOSE.

  Patient problems: Insufficient Information

  MAUDE report 21874498 ↗
• MalfunctionMar 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA (B)(4) THAT AN AR-1934PS SUTURE ANCHOR RELEASED FROM ITS EYELET. THIS OCCURRED DURING USE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Insufficient Information

  MAUDE report 21619232 ↗
• MalfunctionJun 3, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE AR-1934PS IMPLANT WAS WELL PLACED. A BONE HAMMER WAS USED TO HAMMER THE END OF THE PRODUCT GENTLY TO SECURE THE IMPLANT INTO THE BONE SOCKET. THE LIGAMENT WAS SEWN. THE IMPLANT WAS OUT OF THE SOCKET WHILE THE TYING THE SUTURE INTO A KNOT. FINALLY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A PRODUCT OF OTHER MANUFACTURER.

  Patient problems: Insufficient Information

  MAUDE report 19449317 ↗
• MalfunctionAug 16, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1934PS PEEK SUTURE TAK PULLED OUT OF THE IMPLANTATION SITE. THE SURGEON USED AN AR-1949 SPEAR AND AN AR-1250LT STEP DRILL TO PREPARE THE BONE SOCKET, BUT THE ANCHOR PULLED OUT DURING TENSIONING. EVERYTHING WAS REMOVED FROM INSIDE THE PATIENT AND THE CASE WAS COMPLETED USING ANOTHER AR-1934PS PEEK SUTURE TAK FROM A DIFFERENT LOT NUMBER. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2023: THIS WAS DISCOVERED DURING AN ANKLE STABILIZATION PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 17559682 ↗
• InjuryJul 11, 2022Loosening of Implant Not Related to Bone-Ingrowth

  ON (B)(6) 2022, IT WAS REPORTED BY A PATIENT THAT HE UNDERWENT AN INTERNAL BRACE PROCEDURE FOR A LIGAMENT REPAIR IN THE ANKLE, IN WHICH THE SURGEON REMOVED THE ENTIRE LIGAMENT. AN ANCHOR WAS IMPLANTED IN THE PATIENT AND IT LOOSENED POST OPERATIVE. PATIENT HAS SOUGHT OUT RECOMMENDATIONS FROM OTHER SURGEONS, HOWEVER, THE SURGEON WHO PERFORMED THE ORIGINAL PROCEDURE WANTS TO DO A REVISION SURGERY AND IMPLANT A BIGGER ANCHOR AND CEMENT IT IN. ADDITIONAL INFORMATION RECEIVED ON 6/3/2022: PER PATIENT, HE HAS UNDERGONE A REVISION SURGERY WITH A DIFFERENT SURGEON THAN THE ONE WHO PERFORMED ORIGINAL PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON 6/23/2022: ORIGINAL PROCEDURE WAS AN RIGHT ANKLE INSTABILITY WITH INTERNAL BRACE, PERFORMED ON (B)(6) 2020. BY (B)(6) OF 2021, PATIENT REPORTED BEING ABLE TO WALK AND EXERCISE. HOWEVER, IN LATE (B)(6) OF 2021, PATIENT STARTED TO EXPERIENCE HIP PAIN BY (B)(6), COULD NOT LONGER WALK. AROUND LATE (B)(6) OR EARLY (B)(6), PATIENT WOKE UP ONE DAY WITH A VERY SWOLLEN ANKLE AND WAS UNABLE TO WALK TO THREE DAYS. OVER THE COURSE OF THREE WEEKS, THE SWOLLENNESS WENT DOWN AND DURING THAT TIME, PATIENT HAD AN X-RAY PERFORMED AS WELL AS AN MRI. THE X-RAY DID NOT S

  Patient problems: Ambulation or Postural Difficulties; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 14976772 ↗
• InjuryJan 19, 2018Break; Entrapment of Device

  IT WAS REPORTED THAT DURING A SHOULDER PROCEDURE THE AR-1934PS ANCHOR BROKE. THE BROKEN PART REMAINS IN THE PATIENT FLUSH WITH THE BONE AND NOT PROTRUDING. THE SURGEON IMPLANTED ANOTHER ONE NEXT TO IT AND IT WORKED FINE. DURING THE SAME PROCEDURE SURGEON WAS IMPLANTING ANOTHER AR-1934PS ON ANOTHER SPOT AND THE SAME EVENT OCCURRED, THE ANCHOR BROKE. HE DRILLED AGAIN NEXT TO IT AND ONCE AGAIN THE SECOND IMPLANT HELD. THE CASE WAS COMPLETED WITH NO FURTHER ISSUES. ADDITIONAL INFORMATION OBTAINED 1/8/2018: THE PROCEDURE WAS A ROTATOR CUFF/LABRUM REPAIR. THE INCIDENT OCCURRED ON THE LABRUM. AS THE SURGEON AS PUSHING DOWN HIS KNOT, A POP WAS HEARD, AND THE SUTURE APPEARED TO RIP OUT OF THE ANCHOR. THE SUTURE WAS INTACT AND THERE WERE NO VISIBLE FRAGMENTS OF THE ANCHOR IN THE JOINT SPACE OR IN THE LABRUM. THE PULLED OUT SUTURE WAS THEN CUT BEFORE INSERTING DIFFERENT ANCHORS. NO PARTS ARE AVAILABLE TO RETURN TO ARTHREX EXCEPT REMAINING UNOPENED ANCHORS FROM THE SAME LOT WHICH WILL BE RETURNED.

  Patient problems: Failure of Implant

  MAUDE report 7205649 ↗