Arthrex® AR-5028C-08Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888867035324), received between Apr 25, 2017 and Jun 27, 2024 — classified as 3 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY THE SCREW DID NOT GRIP AND COULD NOT BE INSERTED TIBIALLY. 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 19626401 ↗
• MalfunctionJun 3, 2024Melted; Melted

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY WHILE INSERTING THE IMPLANT MELTED. 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. *** 02-SEP-2021 UPDATE DW FURTHER INFORMATION WAS PROVIDED THAT THE REPORTED SCREW WAS JUST DEFORMED AND DID NOT MELT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19446930 ↗
• MalfunctionAug 15, 2022Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR SURGERY THE DEVICE BROKE. ACCORDING TO THE SURGEON 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15223780 ↗
• MalfunctionApr 25, 2022Material Twisted/Bent

  IT WAS REPORTED THAT DURING ANTERIOR CRUCIATE LIGAMENT SURGERY DURING THE FIRST TURNS OF THE SCREW, WHEN INSERTING, THE SCREW THREAD ON THE SCREW HEAD TWISTED OFF DIRECTLY. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH PART NUMBER 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 14192646 ↗
• MalfunctionJan 4, 2022Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY THE DEVICE DID NOT FIT WELL IN THE SCREW DRIVER. A PIECE OF THE DEVICE BROKE OF INSIDE THE PATIENT, BUT 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 DIFFERENT DEVICE. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 13152518 ↗
• 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 DEVICES. ONLY A VERY SHORT PART OF THE DRIVER GOT INSERTED IN THE DEVICES WHICH LEAD TO A BREAKAGE OF THE DEVICES WHILE PLACING THEM. EACH 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 DIFFERENT DEVICES. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 12897103 ↗
• MalfunctionJun 28, 2021Break; Fitting Problem

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY THE DEVICE DIDN`T FIT IN THE SCREWDRIVER. AFTER THE SCREWDRIVER WAS FORCED INTO THE DEVICE IT WAS NOT POSSIBLE TO IMPLANT THE DEVICE PROPERLY IN THE TIBIAL TUNNEL. THE DEVICE BROKE INSIDE THE PATIENT AND A CLAMP WAS USED TO SECURE THE IMPLANT IN PLACE. THE BROKEN PART 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: Insufficient Information

  MAUDE report 12076284 ↗
• InjuryFeb 15, 2019Break

  IT WAS REPORTED THAT DURING A AN ANTERIOR CRUCIATE LIGAMENT SURGERY WHEN INSERTING THE BIOCOMPOSITE SCREW THE TIP BROKE OFF AND WAS LEFT IN THE JOINT. THE SURGEON WAS NOT ABLE TO RETRIEVE THE BROKEN PIECE. 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 29-JAN-2019: THE BROKEN FRAGMENT IS SCREWED TIGHT IN THE JOINT. IT CANNOT MOVE.

  Patient problems: Foreign Body In Patient

  MAUDE report 8344600 ↗
• InjuryMay 3, 2018Loose or Intermittent Connection

  IT WAS REPORTED THAT THE INITIAL SURGERY WAS ON (B)(6) 2017. PLACE OF THE TUNNEL WAS TIBIALLY SCORED. SCREW LOOSENED AND WAS PULLED OUT BY HAND 3 MONTHS LATER. (NO INFECTION PRESENT) FOLLOW-UP INVESTIGATION: IN (B)(6) 2018 THE PATIENT COMPLAINED ABOUT PAIN. THE SCREW WAS NOTICEABLE UNDER THE SKIN. ACCORDING TO THE SURGEON THE PATIENT WAS COMPLIANT TO THE POST-OP GUIDELINES. THERE WAS AN UNPLANNED SECOND SURGERY WHICH TOOK PLACE ON (B)(6) 2018. THE PATIENT HAD STERILE PUS WHICH WAS TREATED WITH ANTIBIOTICS. ACCORDING TO THE SURGEON THE CULTURES WERE TESTED AND REVEALED NO BACTERIAL INFECTION.

  Patient problems: Pain; Purulent Discharge

  MAUDE report 7483532 ↗
• InjuryApr 25, 2017Break

  IT WAS REPORTED THAT THE SCREW BROKE DURING INSERTION INTO THE TIBIA. ABOUT 1/3 OF THE SCREW WAS INSERTED WHEN IT BROKE. SURGEON DECIDED NOT TO USE A NEW SCREW BUT TO LEAVE THE BROKEN PART OF SCREW IN THE BONE FOR FIXATION OF THE TENDON. IT WAS REPORTED THAT PATIENT MUST NOT PUT LOAD ON THE LEG FOR 6 WEEKS POST-OP IN ORDER TO ENABLE THE IMPLANT TO INCORPORATE TO THE BONE.

  Patient problems: Foreign Body In Patient

  MAUDE report 6520185 ↗