Arthrex® AR-8980P-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867319912), received between Jun 27, 2022 and Dec 24, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 24, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR TALOFIBULAR LIGAMENT INTERNALBRACE SURGERY THE ANCHOR BROKE ON THE LAST TURN, BUT THE SURGEON COULD PULL OUT THE ANCHOR ON THE HOLDING SUTURES. NO BROKEN PART REMAINED INSIDE THE PATIENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (AR-2323BCC). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888572 ↗
• MalfunctionJun 26, 2025Positioning Failure; Positioning Failure

  ON 20TH JUNE 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AN AR-2323BCC, SUTURE ANCHOR, BIOCOMPOSITE SWIVELOCK® C, 5.5 MM X 19.1 MM, CLOSED EYELET, INITIALLY AR-8980P-1, DX SWIVELOCK®, 4.75 MM X 16.1 MM, PEEK, WAS INSERTED, THE SURGEON EXPRESSED CONCERN ABOUT INADEQUATE FIXATION AND REMOVED THE IMPLANT. THE 5.5 SWIVELOCK WAS DISCUSSED AND ACCEPTED AS AN ALTERNATIVE. (HOSPITAL SHELF STOCK). DUE TO THE ABSENCE OF A SCOUT NURSE, THE IMPLANT WAS RETRIEVED AND OPENED WITHOUT CHECKING THE EXPIRY DATE BY THE ARTHREX SALES REP. THE IMPLANT WAS PARTIALLY INSERTED BEFORE THE EXPIRY DATE WAS NOTICED. (SUTURE LOADED AND EYELET AT HOLE). THE SURGEON WAS IMMEDIATELY INFORMED AND CHOSE TO PROCEED WITH THE EXPIRED IMPLANT, ACKNOWLEDGING THE EXPIRY FOR DOCUMENTATION PURPOSES. THE SALES REP INFORMED THE REGIONAL SALES MANAER POST OP AND SPORTS REP ONSITE WHO DISCUSSED THE EVENT WITH THE HOSPITAL STAFF AND SURGEON. THIS WAS DETECTED DURING USE IN AN ANKLE RECONSTRUCTION ATFL IB PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AS THE EXPIRED IMPLANT WAS IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 22336808 ↗
• InjuryOct 25, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT EXPERIENCED AN ALLERGIC REACTION DUE TO THE PEEK MATERIAL WHICH RESULTED IN WOUND HEALING DISORDER AND REACTION TO THE MATERIAL. NO FURTHER INFORMATION RECEIVED. UPDATE (B)(6) 18-OCT-2024: FURTHER INFORMATION WAS PROVIDED THAT THE INITIAL SURGERY WAS PERFORMED (B)(6) MONTHS AGO IN (B)(6) 2024. THE ANCHOR IS STILL IMPLANTED IN THE PATIENT. THE PATIENT SUFFERS DIFFUSE PAIN BUT THERE IS NO CLEAR INDICATION THAT IT COMES FROM THE ANCHOR, AND THEREFORE THE ANCHOR WAS NOT REMOVED BY NOW. THE SURGEON NOW PLANS SOME ADDITIONAL ALLERGIC TESTS. NO FURTHER INFORMATION WAS MADE AVAILABLE BY THE CUSTOMER.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 20537550 ↗
• MalfunctionMar 28, 2024Break; Break

  IT WAS REPORTED THAT DURING A RIGHT ARM TRICEP REPAIR SURGERY THE SWIVELOCK BROKE WHEN IT WAS INSERTED. ACCORDING TO THE SURGEON NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY OCCURRED. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A DIFFERENT DEVICE (AR-9879P). IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18990983 ↗
• MalfunctionOct 24, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPIC SUTURING OF THE MENISCUS THE SCREW OF THE DEVICE BROKE WHILE TIGHTENING INTO THE PRE-DRILLED CHANNEL. 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. UPDATE AVOE 09-OCT-2023: IT WAS CONFIRMED THAT ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17997187 ↗
• MalfunctionSep 12, 2022Break

  IT WAS REPORTED THAT DURING AN INTERNAL BRACE LIGAMENT AUGMENTATION THE BOLT BROKE DURING SCREWING IN. 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 15401811 ↗
• MalfunctionJun 27, 2022Break

  IT WAS REPORTED THAT DURING AN ANKLE ARTHROSCOPY THERE WAS A BREAK OF THE BOLT WHILE SCREWING THE IMPLANT. 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) 2022: THE SCREW WAS BROKEN WHILE INSERTING THE IMPLANT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14828600 ↗