Arthrex® AR-1318FT-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00888867282322), received between Apr 27, 2021 and Aug 19, 2026 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Break” (7 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.

• MalfunctionAug 19, 2026Loose or Intermittent Connection; Component Misassembled

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50325265 ↗
• MalfunctionJun 2, 2025Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING A HAND SURGERY THE ANCHOR DID NOT HOLD, TWISTED IN THE BONE AND COULDN'T BE FIXATED. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22124120 ↗
• MalfunctionOct 16, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ULNAR COLATERAL LIGAMENT REPAIR SURGERY THE SUTURE TORE AFTER INSERTING INTO THE PHALANX. THE SURGEON REPORTED THAT THE SUTURE LOADED INTO THE ANCHOR WAS ALREADY WEAKENED BEFORE THE ANCHOR INSERTION. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE PART NUMBER: AR-1317FT-1. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE KPILZ 10-OCT-2024: THE TWO DEVICES AR-1318FT-1 REMAINED INSIDE THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 20461524 ↗
• MalfunctionOct 16, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN ULNAR COLLATERAL LIGAMENT REPAIR SURGERY THE SUTURE TORE AFTER INSERTING INTO THE PHALANX. THE SURGEON REPORTED THAT THE SUTURE LOADED INTO THE ANCHOR WAS ALREADY WEAKENED BEFORE THE ANCHOR INSERTION. PER COMPLAINT REPORTER 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. UPDATE (B)(6) 10-OCT-2024: THE TWO DEVICES AR-1318FT-1 REMAINED INSIDE THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 20461499 ↗
• MalfunctionJun 13, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A TFCC (TRIANGULAR FIBROCARTILAGE COMPLEX) SURGERY AFTER IMPLANTATION OF THE MICRO CORKSCREW IN THE PATIENT'S BONE, ONLY ONE SUTURE WAS RELEASED. THE OTHER SUTURE WAS STUCK IN THE SCREWDRIVER. AN ATTEMPT WAS MADE TO FREE IT BY PIVOTING THE TITANIUM WINGS OF THE SCREWDRIVER, BUT THIS DISRUPTED THE STRUCTURE OF THE SUTURE. IT WAS NECESSARY TO CUT THE THREAD AND EXTRACT THE IMPLANT FROM THE PATIENT'S BONE. 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 19533936 ↗
• MalfunctionMar 18, 2024Break; Break

  IT WAS REPORTED THAT DURING A SLIL RECONSTRUCTION SURGERY THE IMPLANT BROKE WHILE BEING SCREWED INTO A PRE-DRILLED HOLE, CAUSING THE SUTURE BREAKAGE. THE BROKEN SUTURE WAS REMOVED FROM PATIENT AND THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY. UPDATE SWIT (B)(6) 2024: FIRST THE ANCHOR BROKE AND THIS CAUSED THE SUTURE BREAKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18923960 ↗
• MalfunctionJan 3, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A WRIST LIGAMENT RECONSTRUCTION THE ANCHOR SLIPPED OUT OF THE BONE AND WAS UNUSABLE. 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 18437109 ↗
• MalfunctionMar 7, 2022Break

  IT WAS REPORTED THAT DURING A HAND ARTHROSCOPY THE ANCHOR BROKE OFF WHEN IT WAS IMPLANTED. THE BROKEN PART WAS RETRIEVED OUT OF THE PATIENT. 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 13684470 ↗
• MalfunctionJul 27, 2021Break

  IT WAS REPORTED THAT DURING A LATERAL ANKLE LIGAMENT RECONSTRUCTION SURGERY THE TIP OF THE CORKSCREW OF THE DEVICE WAS DAMAGED DURING INSERTION. 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 12231652 ↗
• MalfunctionJul 27, 2021Break; Device Slipped

  IT WAS REPORTED THAT DURING A LATERAL ANKLE LIGAMENT RECONSTRUCTION SURGERY THE IMPLANT OF THE DEVICE FELL OFF THE CORKSCREW DURING INSERTION. THE BROKEN OFF 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 12231628 ↗
• MalfunctionMay 10, 2021Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING A HAND SURGERY THE ANCHOR CUT THE SUTURE DURING SCREWING IN. THE BROKEN OFF 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: Insufficient Information

  MAUDE report 11798580 ↗
• MalfunctionApr 27, 2021Break

  IT WAS REPORTED THAT DURING A SURGERY THE SURGEON HAD A PROBLEM WITH THE ITEMS AS TWO ANCHORS BROKE. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 11730831 ↗
• MalfunctionApr 27, 2021Break

  IT WAS REPORTED THAT DURING A SURGERY THE SURGEON HAD A PROBLEM WITH THE ITEMS AS TWO ANCHORS BROKE. NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 11730826 ↗