Arthrex® AR-1778P-CPRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867318120), received between Sep 27, 2023 and Feb 10, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN INITIAL SURGERY IN WHICH AN AR-8991 WAS USED, THE KNOTLESS FIBERTAK SUTURE WAS PULLED OUT OF AN OPEN WOUND THAT WOULD NOT HEAL. PART OF THE DEVICE REMAINED INSIDE THE PATIENT. NO FURTHER INFORMATION RECEIVED. ***UPDATE 14-JAN-2026. IT WAS FURTHER REPORTED THAT THE ORIGINAL SURGERY WAS PERFORMED ON THE 10TH OF NOVEMBER 2025 AND THE REVISION SURGERY WAS PERFORMED ON THE (B)(6) 2026. NOTHING WAS REMOVED UNTIL THE FIRST CHECK-UP, WHERE THE SURGEON PULLED SOME SUTURE OUT OF THE WOUND WHICH WASN'T HEALING. THE PATIENT WAS THEN SCHEDULED FOR THE SECOND SURGERY TO REMOVE THE ANCHORS AND TAPE/SUTURES PROPERLY. THE PATIENT WAS YOUNG AND, IN THIS PERIOD, HAD HEALED ENOUGH TO BE STABLE AND DIDN'T NEED ANY FURTHER IMPLANTS. ***UPDATE 22-JAN-2026. IT WAS FURTHER REPORTED THAT THE SURGEON ALSO USED THE DEVICE AR-1778P-CP ON THE PATIENT, WHICH WAS REMOVED FROM THE PATIENT ON THE (B)(6) 2026.

  Patient problems: Impaired Healing

  MAUDE report 24307293 ↗
• MalfunctionMay 6, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANKLE INSTABILITY SURGERY THETIP OF THE 2.7MM CANNULATED DRILL BROKE OFF. ALL BROKEN PARTS WERE RETRIEVED. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH ANOTHER DRILL FROM THE KIT. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21968763 ↗
• MalfunctionMay 6, 2024Break; Break

  ON 11/3/2021, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1778P-CP INTERNALBRACE IMPLANT SYSTEM 4.75MM SWIVELOCK IMPLANT HANDLE DISLODGE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2021 ADDITIONAL INFORMATION RECEIVED 11/5/2021: AR-1778P-CP SWIVELOCK HANDLE CAME OFF THE METAL SHAFT WHEN SURGEON ATTEMPTED TO INSERT IMPLANT; HOWEVER, SURGEON WAS STILL ABLE TO IMPLANT SWIVELOCK PEEK SUCCESSFULLY DURING INTERNAL BRACE PROCEDURE ON THE ANKLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19248075 ↗
• MalfunctionApr 25, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE IMPLANT LABELS ARE MISSING. THE PROBLEM WAS NOTICED AFTER THE SURGERY/ TREATMENT. THERE WAS NO HARM OR ADVERSE EVENT FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19186119 ↗
• MalfunctionJan 23, 2024Break; Break

  IT WAS REPORTED THAT DURING AN INTERNALBRACE LIGAMENT RECONSTRUCTION SURGERY A DRILL BIT OF THE AR-1778P-CP KIT BROKE OFF INSIDE THE PATIENT. THE BROKEN PIECES WERE RETRIEVED FROM PATIENT. 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 18564741 ↗
• MalfunctionSep 27, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A SURGERY THE 2, 7MM ANCHOR BENT WHEN PLACED IN THE DRILL CHANNEL. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED. UPDATE AVOE 31-AUG-2023 IT WAS CONFIRMED THAT THE ERROR OCCURRED DURING A SG-BANDAUGMENTATION SURGERY. AFTER CONSULTATION WITH THE SURGEON IN CHARGE, THE METAL DEVICE ON THE 3.5 MM SWIVELOCK ANCHOR (WHICH IS INCLUDED IN THE KIT) WAS BENT BY LEVERING IT TOO HARD. THE SWIVELOCK ANCHOR ITSELF WAS NOT DAMAGED. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH THE SAME DEVICE. 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 17825248 ↗