Arthrex® AR-1934PI-30Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00888867024151), received between Sep 5, 2018 and Mar 19, 2026 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 19, 2026Break

  ON (B)(6) 2026, IT WAS REPORTED BY ARTHREX LEGAL VIA EMAIL THAT A PATIENT UNDERWENT A PROCEDURE TO CORRECT A GLENOHUMERAL INSTABILITY ON (B)(6) 2022. THE PATIENT COMPLAINED OF NECK AND SHOULDER PAIN FOR A PERIOD FOLLOWING THE SURGERY. A FOLLOW-UP X RAY IN 2023 REVEALED A BROKEN METAL FRAGMENT IN THE SHOULDER SPACE. THE ORIGIN DEVICE OF THE METAL FRAGMENT IS UNKNOWN. THERE WAS A REVISION PROCEDURE IN (B)(6) 2024 TO REMOVE THE FRAGMENT. THE PRODUCTS USED IN THE ORIGINAL PROCEDURE WERE: AR-1934PI-30 PERC INSERT KIT, (3) THREE AR-1938BC SUTURE ANCHOR, (3) THREE AR-3636 FIBERTAK ANCHORS, AND (2) TWO AR-6570F FLEXIBLE CANNULAS.

  Patient problems: Foreign Body In Patient

  MAUDE report 24637949 ↗
• MalfunctionMay 23, 2024Fitting Problem; Fitting Problem

  IT WAS REPORTED ON 07/15/2022 BY A FACILITY REPRESENTATIVE VIA SEMS THAT AN AR-1934PI-30NITINOL WIRE WOULD NOT FIT THROUGH THE DILATOR IN THE PERCUTANEOUS KIT.. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM. PER FACILITY: "DURING A SUPERIOR CAPSULAR RECONSTRUCTION, THE SURGEON WAS TRYING TO INSERT SOME 3.0 SUTURETAKS PERCUTANEOUSLY ON THE GLENOID. WHEN DOING THE SEQUENTIAL STEPS TO INSERT THE ANCHORS PERCUTANEOUSLY WITH THE KIT, THE NITINOL WIRE WOULD NOT FIT THROUGH THE DILATOR IN THE PERCUTANEOUS KIT. THE SIZING WAS VERY OFF IT SEEMS, THEREFORE THE KIT WAS UNABLE TO BE USED DUE TO IT NOT FUNCTIONING PROPERLY. WE HAD TO DISCARD THE KIT AND OPEN A NEW ONE. THE KIT WAS VERY CLEARLY DEFECTIVE"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19387972 ↗
• MalfunctionNov 6, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  ON (B)(6),2023 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1934PI-30 PERCUTANEOUS INSERTION KITS DRILL GOT STUCK IN THE GUIDE AND COULD NOT BE REMOVED. THIS OCCURRED DURING A CASE, AND ANOTHER DRILL WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18074015 ↗
• InjurySep 5, 2018Detachment of Device or Device Component

  IT WAS DISCOVERED DURING MAUDE REVIEW AND WAS RECEIVED VIA FDA MEDWATCH LETTER (MW5078672) THAT A PATIENT HAD UNDERGONE A RIGHT SHOULDER ARTHROSCOPY WITH INFERIOR LABRAL REPAIR. PATIENT WAS DOING WELL AND BEGAN HAVING INCREASING DISCOMFORT TO THIS RIGHT ELBOW OVER A PERIOD OF THREE DAYS WITH SIGNIFICANT PAIN AND LUMP NOTED PROXIMAL TO THE ANTECUBITAL FOSSA NEAR THE DISTAL BICEPS TENDON, WITH NO REPORT OF INJURY, WHICH PROMPTED PATIENT TO GO TO THE CLINIC. X-RAYS OBTAINED IN THE CLINIC INDICATED OBVIOUS METAL FOREIGN BODY LOCATED WITHIN THE RIGHT ELBOW. PATIENT WAS SCHEDULED FOR FOREIGN BODY REMOVAL FROM THE RIGHT ELBOW. OP NOTE INDICATED "THE OBJECT WAS A METAL NITINOL GUIDE-WIRE". SURGEON CONSULTED WITH PATIENT'S PARENTS. THE FOLLOWING WAS ALSO NOTED ON THE FDA MEDWATCH LETTER RECEIVED BY ARTHREX: EVENT WAS REPORTABLE TO THE STATE OF MN (4. RETENTION OF A FOREIGN OBJECT IN A PATIENT AFTER SURGERY OR OTHER INVASIVE PROCEDURE, EXCLUDING OBJECTS INTENTIONALLY IMPLANTED AS PART OF A PLANNED INTERVENTION AND OBJECT PRESENT PRIOR TO SURGERY THAT ARE INTENTIONALLY RETAINED). DEVICE WAS A FRAGMENT FROM A PERCUTANEOUS INSERTION KIT FOR 3 MM SUTURE-TAK LABRAL REPAIR. ADDITIONAL INFORMATION

  Patient problems: Discomfort; Foreign Body In Patient; Pain

  MAUDE report 7845653 ↗