Arthrex® AR-4157-20Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00888867187825), received between Sep 8, 2016 and Jan 28, 2025 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (11 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 28, 2025Device Damaged by Another Device; Device Damaged by Another Device

  ON (B)(6)2024 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE HEAD OF AN AR-4157-20 RETROFUSION SCREW STRIPPED IMMEDIATELY. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION RECEIVED ON 1/8/2025: THE HAMMERTOE PROCEDURE WAS COMPLETED USING A NEW AR-4157-20 RETROFUSION SCREW WITH THE SAME AR-4157DS DRIVER THAT STRIPPED THE PREVIOUS SCREW. THE CASE WAS NOT DELAYED, AND ADDITIONAL ANESTHESIA WAS NOT NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21252006 ↗
• InjuryJul 1, 2020Break

  IT WAS REPORTED THAT WHEN INSERTING THE RETROFUSION SCREW INTO THE PHALANX, THE SCREW BROKE IN HALF. THE BROKEN HALF REMAINS IN THE PATIENT. THIS WAS A HAMMERTOE / PLANTAR PLATE REPAIR; THEY COMPLETED THE CASE USING SUTURE IN THE JOINT TO PULL THE SOFT TISSUE TOGETHER TO AID IN THE FUSION O F THE JOINT. , NO MORE ANCHORS WERE USED AND NO ADDITIONAL INCISIONS WERE NEEDED. . INSERTING THE SCREW INTO THE PHLANAX, THE SCREW BROKE IN HALF, THE SCREW REMAINS IN THE PATIENT. NO PATIENT INFORMATION WAS AVAILABLE.

  Patient problems: Device Embedded In Tissue or Plaque; Tissue Damage

  MAUDE report 10217901 ↗
• InjuryJan 14, 2020Break

  IT WAS REPORTED THAT DURING A PIP JOINT FIXATION PROCEDURE; AS THE SURGEON WAS COMPLETING THE FDH/FHL EXTENSION AND FIXATION OF 2ND TO 5TH TOE, THE RETROFUSION SCREW, (B)(4), BROKE AT THE MIDDLE OF THE SHAFT; LEAVING BROKEN PIECES INSIDE THE PROXIMAL PHALANX. THE BROKEN PIECES WERE COMPLETELY REMOVED DURING THE SURGERY USING A SCREW EXTRACTION DEVICE MADE BY ANOTHER MANUFACTURER. THE BONE HOLE WAS SUPPLEMENTED WITH BONE FROM THE OTHER TOES, AND THE 3RD TOE ON THE RIGHT FOOT WAS FIXED WITH A C WIRE. THE SURGERY WAS COMPLETED, AND NO ABNORMALITIES WERE FOUND IN POST-OPERATIVE X-RAYS. THE PROCEDURES FOR THE 4TH AND 5TH TOES ON THE RIGHT FOOT AND THE 3RD TO 5TH TOE OF THE LEFT FOOT WERE CHANGED TO A PROCEDURE THAT UTILIZES C WIRES.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9585892 ↗
• InjuryDec 10, 2019Difficult to Remove

  IT WAS REPORTED DURING A HAMMERTOE REPAIR PROCEDURE, THE DISTAL PORTION OF THE AR-4157-20 RETROFUSION SCREW (20 MM) SNAPPED OFF WHILE THE SURGEON WAS USING THE DRIVER TO INSERT THE SCREW INTO THE PROXIMAL PHALANX, LEAVING JUST THE PROXIMAL PART OF THE SCREW INSERTED IN THE PATIENT. THE REP REPORTED THE BROKEN FRAGMENT WAS RETRIEVED AND THE SURGEON HAD TO SWITCH SURGICAL TECHNIQUES AND FIXATE WITH K-WIRES INSTEAD. THE CASE WAS COMPLETED AND A SECOND SURGERY IS NOT NECESSARY. ADDITIONAL INFORMATION RECEIVED ON 11/21/2019: THE REP REPORTED THE FULL SCREW WAS REMOVED FROM THE PATIENT AND WILL BE RETURNING FOR EVALUATION. THE SURGEON REMOVED THE SCREW BY USING A RONGEUR TO TURN THE SCREW COUNTER-CLOCKWISE TO REMOVE. FULL REMOVAL OF THE SCREW CAUSED THE SURGEON TO HAVE TO RESECT MORE BONE THAN THEY HAD INITIALLY WANTED TO. THE BONE WAS PREPPED BY USING THE DRILL IN THE RETROFUSION DISPOSABLE KIT. THE BONE QUALITY WAS HARD.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9443606 ↗
• InjuryJul 23, 2019Break; Entrapment of Device; Difficult to Advance

  IT WAS REPORTED THAT DURING A HAMMERTOE PROCEDURE, THE SURGEON DRILLED AND PREPPED THE BONE PER THE SURGICAL TECHNIQUE. UPON INSERTION OF THE RETROFUSION SCREW, AR-4157-20, THE SURGEON MET RESISTANCE. HE BACKED OUT THE SCREW AND RE-DRILLED TO TRY AGAIN. AGAIN, AS HE WAS ATTEMPTING TO ENGAGE THE SCREW, HE MET RESISTANCE AND WAS HAVING DIFFICULTY GETTING THE SCREW TO ADVANCE. HE AGAIN ATTEMPTED TO BACK THE SCREW OUT BUT THIS TIME, THE SCREW SNAPPED WHERE THE THREADS MEET THE SHAFT OF THE SCREW. THE SURGEON USED A SYNTHES SCREW REMOVAL KIT TO CORE AROUND THE SCREW MAKING A DORSAL CUT IN THE BONE IN ORDER TO REMOVE IT. ALL FRAGMENTS WERE REMOVED FROM THE PATIENT AND DISCARDED. THE SURGEON USED A K-WIRE FOR FIXATION TO COMPLETE THE CASE WITH NO ADVERSE EFFECT TO THE PATIENT. PATIENT IS A FEMALE, (B)(6).

  Patient problems: Failure of Implant; Foreign Body In Patient

  MAUDE report 8817483 ↗
• InjuryFeb 15, 2019Break

  IT WAS REPORTED THAT THE HEAD OF THE SCREW BROKE-OFF DURING INSERTION; IT REMAINS IN THE PATIENT. THIS WAS A HAMMERTOE CASE ON THE SECOND TOE. (B)(6) MALE PATIENT. AT THE FIRST ATTEMPT TO INSERT, THE SURGEON ENCOUNTERED HARD BONE. HE BACKED OUT THE SCREW AND REDRILLED THE SITE. AT THE SECOND ATTEMPT, THE HEAD BROKE OFF. THE BODY OF THE SCREW REMAINS IN THE PATIENT'S TOE; THE SURGEON PUT A PIN IN THE CENTER OF THE TOE NEXT TO THE SCREW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8344520 ↗
• InjuryNov 13, 2018Break

  IT WAS REPORTED THAT DURING A HAMMERTOE PROCEDURE, THE RETROFUSION SCREW, AR-4157-20, BROKE ON INSERTION INTO THE PROXIMAL PHALANX (2ND TOE). BONE WAS PREPPED WITH K-WIRE AND DRILL. THE SCREW BROKE RIGHT AT THE JUNCTION. THE SCREW TIP WAS UNABLE TO BE REMOVED AND A K-WIRE WAS INSERTED ON THE SIDE OF THE BROKEN SCREW TIP AND THE CASE WAS COMPLETED.

  Patient problems: Failure of Implant

  MAUDE report 8065489 ↗
• InjuryJul 24, 2018Break; Material Twisted/Bent

  IT WAS REPORTED THAT DURING SCREWING IN THE RETROFUSION SCREW WITH MODERATE FORCE, THE DEVICE BENT. WHEN THE SURGEON TRIED TO UNSCREW THE DEVICE THE SCREW BROKE ON THE PROXIMAL PART. IT WAS NOT POSSIBLE TO RETRIEVE THE BROKEN FRAGMENT. IT WILL REMAIN INSIDE THE TOE. THE PERFORMED SURGERY WAS AN PROXIMAL INTERPHALANGEAL JOINT ARTHRODESIS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A K-WIRE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7713376 ↗
• InjuryJun 14, 2018Break; Detachment Of Device Component

  IT WAS REPORTED THAT DURING A HAMMERTOE CASE, THE SITE HAD BEEN PRE-DRILLED; WHEN THE SCREW AR-4157-20 WAS BEING INSERTED INTO THE PROXIMAL PHALANX, THE SCREW HEAD BROKE OFF. THE PART OF THE SCREW THAT HAD ALREADY INSERTED REMAINS IN THE PATIENT; THERE WERE NO SCREWS PLACED ON TOP OF IT AND THE CASE WAS COMPLETED WITH K-WIRES. THE PATIENT IS A (B)(6) YEARS OLD FEMALE; THE REP WAS IN THE CASE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7600187 ↗
• InjuryMar 23, 2018Break

  IT WAS REPORTED THAT DURING A HAMMERTOE CORRECTION PROCEDURE, THE SURGEON PREPPED THE PATIENT'S BONE USING PROPER TECHNIQUE USING THE DISPOSABLE KIT. WHEN HE WENT TO INSERT THE 20MM RETROFUSION SCREW, THE SCREW BROKE IN HALF. THE TIP OF THE SCREW WAS RETRIEVED AND A CORING REAMER WAS USED TO EXPOSE ENOUGH SO THAT THE SURGEON COULD GRAB THE SCREW WITH PLIERS AND TWIST THE BODY OF THE SCREW OUT. BONE GRAFTING AND A K-WIRE WERE USED TO COMPLETE THE CASE WITH NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 7365034 ↗
• InjuryJun 6, 2017Break

  IT WAS REPORTED THAT THE SCREW BROKE IN HALF DURING INSERTION INTO THE BONE. THE BROKEN HALF REMAINS IN THE PATIENT. THE CASE WAS COMPLETED WITH K-WIRE. PROCEDURE WAS A HAMMERTOE PROCEDURE AND THE SITE WAS PRE DRILLED PER THE REP PRESENT IN CASE, THE SCREW WAS GETTING TIGHT DURING THE INSERTION PRIOR TO BREAKAGE. PATIENT WAS REPORTED TO HAVE HARD BONE. X-RAY PICTURE WAS PROVIDED TO ARTHREX.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6614560 ↗
• InjuryJan 10, 2017Break; Difficult to Remove; Physical Resistance

  IT WAS REPORTED THAT DURING A 2ND AND 3RD HAMMERTOE CORRECTION PROCEDURE, THE SURGEON WAS ATTEMPTING TO INSERT AN AR-4157-20, LOT 10053198, (B)(4) 20 MM RETROFUSION SCREW INTO THE 2ND TOE. THE SCREW SNAPPED OFF UPON INSERTION INTO THE PROXIMAL PHALANX, THE PORTION OF THE SCREW THAT WAS IN THE BONE WAS REMOVED. THE SURGEON RE-DRILLED UP TO THE FIRST LASER LINE USING THE 2.0 DRILL FROM THE KIT AND ANOTHER AR-4157-20 LOT 10072430 ((B)(4)) 20 MM RETROFUSION SCREW WAS USED. THE SURGEON FELT RESISTANCE WHILE TRYING TO SEAT THE SECOND SCREW SO HE STOPPED AND ATTEMPTED TO REMOVE THE SCREW. THE SCREW SUBSEQUENTLY SNAPPED UPON REMOVAL. THE PORTION OF THE SCREW THAT REMAINED IN THE PATIENT'S BONE WAS UNABLE TO BE RETRIEVED AND WAS CUT FLUSH WITH THE BONE WITH THE A PIN CUTTER. SALES REP STATED THAT THE SURGEON CONCLUDED THAT THE PATIENT'S BONE WAS EXTRAORDINARILY HARD.

  Patient problems: Tissue Damage

  MAUDE report 6236128 ↗
• InjurySep 8, 2016Break

  IT WAS REPORTED THAT DURING A PROCEDURE FOR A HAMMER TOE (2ND TOE), ARTHROCARE RESURFACING AT MPT JOINT (2ND TOE) AND PLANTA PLATE REPAIR (3RD TOE PROCEDURE THE FOLLOWING OCCURRED DURING THE HAMMER TOE (2ND TOE) PORTION OF THE PROCEDURE. THE SURGEON WAS ADVANCING THE AR-4157-20 RETRO FUSION 20 MM SCREW SO THAT THE DISTAL THREADS WOULD BE AGAINST THE PROXIMAL PHALANX WITHOUT ENGAGING THE THREADS INTO THE BONE AND THE SCREW BROKE ON THE PROXIMAL SIDE OF THE SCREW END WHERE THE NON THREADED PORTION OF THE SCREW BEGINS. THE SURGEON HAD NO WAY TO REMOVE THE REMAINING SCREW THAT WAS IN THE BONE AS THERE WAS NO WAY TO GRAB IT. THE BROKEN SCREW WAS FULLY IMPLANTED INTO THE BONE WITH NO PORTIONS EXTRUDING INTO THE JOINT. THE SURGEON APPLIED DBM TO THE PREPPED JOINT AS BEST POSSIBLE AND CLOSED THE SOFT TISSUE WITH THE TOE IN AN EXTENDED POSITION. SURGEON WILL TREAT CONSERVATIVELY TO ALLOW THE BONE TO FUSE STRAIGHT. NO PATIENT INJURY REPORTED.

  Patient problems: No Code Available

  MAUDE report 5935618 ↗