Arthrex® AR-8933-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867049567), received between Jun 30, 2020 and Aug 16, 2023 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryAug 16, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED, THAT THE PATIENT UNDERWENT SURGERY ON (B)(6) 2018. FOR AN OPEN REDUCTION INTERNAL FIXATION OF A LEFT TRIMALLEOLAR ANKLE FRACTURE, WITH FIXATION OF THE DISTAL FIBULA FRACTURE, POSTERIOR MALLEOLUS FRACTURE, AND SYNDESMOTIC FIXATION. DURING THE (B)(6) 2018 SURGERY, THE FOLLOWING PRODUCTS WERE USED AND/OR IMPLANTED: AR-8740-52, PTS QCKFIX SCRW, TI, CANN ST, CANC., 4.0X 52MM, LOT/SERIAL#: (B)(6); AR-8925T K, -LESS T-ROPE W/DRV, SYN REPR, TI, LOT/SERIAL#: (B)(6); AR-8933-20, LO-PRO SCRW, TI, 3.0MMX 20MMCORT, LOT/SERIAL#: (B)(6); AR-8933V-12, 3.0 X 12MM VAL SCREW, TI, LOT/SERIAL#: (B)(6); AR-8933V-14, 3.0 X 14MM VAL SCREW, TI, LOT/SERIAL#: (B)(6); AR-8933V-16, 3.0 X 16MM VAL SCREW, TI, LOT/SERIAL#: (B)(6); AR-8933V-18, 3.0 X 18MM VAL SCREW, TI, LOT/SERIAL#: (B)(6); AR-8933V-20, 3.0 X 20MM VAL SCREW, TI, LOT/SERIAL#: (B)(6); AR-8935-12, LO-PRO SCRW, TI, 3.5MMX 12MM, LOT/SERIAL#: (B)(6); AR-8935-14, LO-PRO SCRW, TI, 3.5MMX 14MM, LOT/SERIAL#: (B)(6); AR-8935-14, LO-PRO SCRW, TI, 3.5MMX 14MM, LOT/SERIAL#: (B)(6); AR-8935-26, LO-PRO SCRW, TI, 3.5MMX 26MM, LOT/SERIAL#: (B)(6); AR-8943-01, GUIDE WIRE, TROCAR TIP, 1.35 MM, LOT/SERIAL#: (B)(6); AR-8943-02, DRILL BIT, CANNULATED, 2

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17561553 ↗
• MalfunctionApr 26, 2021Break

  IT WAS REPORTED THAT THE HEAD OF THE SCREW BROKE OFF, LEAVING THE REMAINDER OF THE SCREW IN THE PATIENT. THIS OCCURRED DURING AN MTP FUSION CASE. THE SURGEON WAS ATTEMPTING TO REMOVE THE SCREW TO USE A SHORTER SCREW WHEN THE HEAD BROKE OFF. PATIENT IS MALE, 40S.

  Patient problems: Foreign Body In Patient

  MAUDE report 11724932 ↗
• MalfunctionFeb 11, 2021Detachment of Device or Device Component

  IT WAS REPORTED THAT WHEN THE SURGEON DID THEIR FINAL TURN OF THE SCREW INTO CORTICAL BONE, THE HEAD OF THE AR-8933-20 SCREW POPPED OFF.

  Patient problems: Insufficient Information

  MAUDE report 11314841 ↗
• InjuryOct 6, 2020Break; Entrapment of Device

  IT WAS REPORTED, THAT DURING A MTC FUSION, UPON INSERTION OF THE AR-8933-20, LO-PROFILE SCREW, AS THE SURGEON REACHED THE PLATE THE HEAD OF THE SCREW BROKE OFF. THE BROKEN FRAGMENT WAS REMOVED. THE SURGEON TRIED TO REMOVE THE BROKEN AR-8933-20 HOWEVER, WAS UNABLE TO REMOVE THE SCREW BODY. THE BODY OF THE SCREW WAS LEFT IN THE PATIENT. THE SURGEON DRILLED A SECOND INSERTION SITE AND THE CASE WAS COMPLETED USING A DIFFERENT AR-8933-20, LO-PROFILE SCREW. ADDITIONAL INFORMATION OBTAINED 09/21/2020: THE SECOND DRILL HOLE WAS NOT PUT INTO THE SAME HOLE AS THE BROKEN SCREW BODY, BUT WAS INSTEAD PUT IN A NEW HOLE IN THE PLATE DISTAL AND PROXIMAL TO THE BROKEN SCREW. THE DISTAL SCREW WAS AN AR-8933-20 AND PROXIMAL TO THE BROKEN SCREW WAS AN AR-8933-18.

  Patient problems: Foreign Body In Patient

  MAUDE report 10634452 ↗
• InjuryJun 30, 2020Material Separation

  IT WAS REPORTED, THAT DURING AN ANKLE PROCEDURE, DURING INSERTION OF THE AR-8933-20, LO-PROFILE SCREW THE HEAD OF THE SCREW BROKE OFF. THE BODY OF THE SCREW WAS LEFT IN THE PATIENT AND IS FLUSH WITH THE FIBULA. THE BROKEN PIECE WAS REMOVED. THE SURGEON DRILLED A SECOND INSERTION SITE AND THE CASE WAS COMPLETED USING A DIFFERENT AR-8933-20, LO-PROFILE SCREW.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10213506 ↗