Arthrex® AR-5028C-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00888867035331), received between Nov 13, 2018 and Jun 26, 2025 — classified as 3 injuries, 12 malfunctions.

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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 26, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SCREW COULD NOT BE INSERTED INTO THE DRILL HOLE. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22337691 ↗
• MalfunctionMay 7, 2024Damaged Thread; Damaged Thread

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE DEVICE DID NOT OFFER ANY HOLD DURING INSERTION. THE THREAD DID NOT GRIP AND DID CLEARLY STRIP OFF. NO PART OF THE DEVICE BROKE OFF. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (AR-5035TC-09). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19257716 ↗
• MalfunctionMar 6, 2024Break; Break

  IT WAS REPORTED THAT DURING A SURGERY THE SCREW BROKE OFF WHEN THE SURGEON SCREWED IT IN. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH A DIFFERENT PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18846213 ↗
• MalfunctionJun 8, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SURGERY THE TIP OF THREE DIFFERENT IMPLANTS BROKE OFF. THE BROKEN PIECES WERE RETRIEVED OUT OF THE PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH AN AR-5028C-09. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. 17-MAY-2023 UPDATE DW: FURTHER INFORMATION WERE PROVIDED THAT THE SURGEON USED ALL THE REPORTED IMPLANTS DURING ONE SURGERY AND THEREFORE EXTENDED THE DRILL HOLE TO 9MM. IT WAS FURTHER REPORTED THAT A PART OF THE LAST IMPLANT WHICH WAS USED TO FINISH THE SURGERY BROKE OFF AS WELL. HOWEVER THE SURGEON WAS SATISFIED WITH THE FIXATION AND THEREFORE FINISHED THE SURGERY WITH THE DAMAGED IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17086024 ↗
• MalfunctionMay 5, 2023Break; Break

  IT WAS REPORTED THAT THE SCREW HAD A DEFECTIVE THREAD. IT WAS NOTICED BEFORE THE SURGERY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. UPDATE SWIT (B)(6) 2023: THE INCIDENT OCCURRED DURING AN ANTERIOR CRUCIATE LIGAMENT REPLACEMENT PLASTIC SURGERY. THE TIP OF THE SCREW BROKE OFF INSIDE THE PATIENT. THE BROKEN PIECE WAS RETRIEVED FROM PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16875653 ↗
• MalfunctionMay 5, 2023Break; Break

  IT WAS REPORTED THAT THE SCREW HAD A DEFECTIVE THREAD. IT WAS NOTICED BEFORE THE SURGERY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. SWIT (B)(6) 2023: THE INCIDENT OCCURED DURING AN ANTERIOR CRUCIATE LIGAMENT REPLACEMENT PLASTIC SURGERY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16875586 ↗
• MalfunctionFeb 16, 2023Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY TWO SCREWS BROKE INSIDE THE PATIENT. ALL BROKEN PARTS WERE RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16385081 ↗
• MalfunctionAug 15, 2022Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) SURGERY WHILE SCREWING IN THE IMPLANT THE BOLT OF THE DEVICE BROKE OFF INSIDE THE PATIENT. THE BROKEN PIECES WERE RETRIEVED FROM PATIENT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15223869 ↗
• MalfunctionNov 30, 2021Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT, POSTERIOR CRUCIATE LIGAMENT AND POSTEROLATERAL CORNER RECONSTRUCTION SURGERY THE SCREW DRIVER DIDN'T FIT IN THE DEVICE. ONLY A VERY SHORT PART OF THE DRIVER GOT INSERTED IN THE DEVICE WHICH LEAD TO A BREAKAGE OF THE DEVICE WHILE PLACING IT. THE BROKEN SCREW HAD TO BE REPLACED WITH A PEEK INTERFERENCE SCREW OF ONE SIZE LARGER TO ACHIEVE PROPER FIXATION OF EACH GRAFT. THE BROKEN PARTS WERE NOT RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 12897185 ↗
• MalfunctionJul 20, 2021Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY THE DEVICE BROKE INSIDE THE PATIENT WHEN TIGHTENING IT AFTER A FEW TURNS. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12196077 ↗
• MalfunctionJun 28, 2021Break; Fitting Problem

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY THE DEVICES DIDN`T FIT IN THE SCREWDRIVER. AFTER THE SCREWDRIVER WAS FORCED INTO THE DEVICES IT WAS NOT POSSIBLE TO IMPLANT THE DEVICES PROPERLY IN THE TIBIAL TUNNEL. THE DEVICES BROKE INSIDE THE PATIENT AND A CLAMP WAS USED TO SECURE THE IMPLANT IN PLACE. THE BROKEN PARTS REMAINED INSIDE THE PATIENT. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 12076258 ↗
• MalfunctionMar 12, 2021Loose or Intermittent Connection

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY THE SCREW THREAD HAS GIVE WAY AFTER THE FIRST TURN. THEREFORE IT WAS NOT POSSIBLE TO INSERT THE IMPLANT. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE 25-FEB-2021 DW: FURTHER INFORMATION WERE PROVIDED THAT THE SCREW HAD NO GRIP AFTER THE FIRST TURN. AFTER THAT THE THREAD BECAME DETACHED AND BROKE OFF. EVERYTHING WAS RETRIEVED OUT OF THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11475556 ↗
• InjuryOct 30, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFLAMMATION IN THE TIBIA IN THE ARE OF THE IMPLANT SOCKET AFTER AN ACL RE-CONSTRUCTION, AND MENISCUS RE-CONSTRUCTION. NO INFORMATION RECEIVED WHEN DEVICE WAS IMPLANTED.

  Patient problems: Inflammation

  MAUDE report 10764225 ↗
• InjuryFeb 8, 2019Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY WHEN SCREWING INTO THE TIBIAL TUNNEL, THE SCREW BROKE ON THE SCREWDRIVER, AT THE MIDDLE OF THE THREAD. SAME PROBLEM OCCURRED WITH THE SECOND IMPLANT. THE BROKEN PIECES REMAIN IN THE PATIENT. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE WHICH WAS USED ANYWAY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE 01-FEB-2019; NOTHING BROKE OFF THE SCREWDRIVER. ONLY THE SCREW BROKE WHILE IT WAS CORRECTLY MOUNTED ON THE SCREWDRIVER. THE SURGEON TRIED TO PUT A SECOND SCREW NEXT TO THE FEMORAL SCREW IN PLACE WITHOUT SUCCESS, IT BROKE TOO. BUT HE DID NOT WANT TO AGGRAVATE THE STRUCTURE THAT COULD BE FRAGILE, HE GAVE UP. THE BROKEN SCREWS SEEM WELL FIXED IN THE BONE. BUT ACCORDING TO SURGEON THERE IS A POSSIBILITY THAT THE FIXATION WILL BREAK, IF IT´S NOT ENOUGH, BUT HE COULD NOT KNOW.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8321948 ↗
• InjuryNov 13, 2018Break

  IT WAS REPORTED THAT DURING A KNEE SURGERY THE SCREW WAS BROKEN OFF. THE BROKEN PART WAS NOT RETRIEVED FROM THE PATIENT AND REMAINS IN THE BONE. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE 31, OCT, 2018: THE BROKEN FRAGMENT IS TIBIALLY FIXED IN THE BONE AND CAN NOT MOVE. NO X-RAY IS AVAILABLE. THE BROKEN PART REMAINS IN THE BONE, NO FURTHER MEASURES WERE TAKEN.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8065748 ↗