Arthrex® AR-1322BCNFRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00888867010147), received between Jun 14, 2019 and Jul 30, 2026 — classified as 6 injuries, 8 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2026Device Dislodged or Dislocated

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50084685 ↗
• MalfunctionJan 26, 2026Detachment of Device or Device Component

  ON 11TH DEC 2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT FOR AR-1322BCNF LOT/SERIAL NO 15394127 SUTURES PULLED OUT OF ANCHOR DURING USE. THIS WAS DETECTED DURING USE A RIGHT ACETABULUM SURGICAL FIXATION KIV RIGHT GREATER TROCHANTER OSTEOTOMY; LEFT ANKLE RELOOKS DEBRIDEMENT KIV CONVERSION TO CIRCULAR FIXATION PROCEDURE ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER ANCHOR, AND NO PIECE BREAK OFF INSIDE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 24180932 ↗
• MalfunctionDec 24, 2025Break; Break

  ON 4TH DEC 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA AN EMAIL THAT FOR 1 UNIT OF AR-1322BCNF, SUTURE ANCHOR, MINI BIOCOMPOSITE SUTURETAK® 2.4 X 8.5 MM WITH 2-0 FIBERWIRE® WITH TWO TAPER POINT NEEDLES, ITS ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER NEW AR-1322BCNF. THERE WERE NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23888096 ↗
• MalfunctionJul 14, 2025Break; Break

  ON 6/17/2025, A DISTRIBUTOR REPORTED VIA EMAIL THAT AN AR-1322BCNF MINI BIOCOMPOSITE SUTURETAK ANCHOR BROKE. THE CASE WAS COMPLETED BY USING A NEW ONE. THIS WAS DISCOVERED DURING AN ANKLE INSTABILITY PROCEDURE ON (B)(6) 2025.

  Patient problems: Insufficient Information

  MAUDE report 22500482 ↗
• MalfunctionNov 11, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY A DISTRIBUTOR VIA EMAIL THAT AN AR-1322BCNF MINI BIOCOMPOSITE SUTURETAK SUTURE BROKE WHEN REMOVING THE HANDLE. THE CASE WAS COMPLETED USING A NEW ANCHOR. THIS WAS DISCOVERED DURING AN ANKLE INSTABILITY PROCEDURE ON (B)(6) 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20652243 ↗
• MalfunctionAug 29, 2022Break

  IT WAS REPORTED THAT DURING A HAND SURGERY THE ANCHOR BROKE OFF DURING INSERTION. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15310894 ↗
• MalfunctionMay 23, 2022Break

  ON (B)(6) 2022, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1322BCNF MINI BIO-COMPOSITE SUTURETAK ANCHOR BROKE. THIS WAS DISCOVERED DURING FOOT AND ANKLE PROCEDURE ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 14469694 ↗
• MalfunctionDec 2, 2021Break

  ON (B)(6) 2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(6) THAT A AR-1322BCNF SUTURE ANCHOR BROKE. THIS OCCURRED DURING USE, UPON INSERTION THE SUTURES IMMEDIATELY BROKE THROUGH THE INNER RIG OF THE ANCHOR. THE CASE WAS COMPLETED SUCCESSFULLY USING A NEW ANCHOR OF THE SAME PART NUMBER AND DIFFERENT LOT NUMBER. THERE WAS NO PATIENT EFFECT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12915370 ↗
• InjuryOct 12, 2020Patient-Device Incompatibility

  IT WAS REPORTED THAT A PATIENT WHO UNDERWENT A SCAPHO-LUNATE LIGAMENT REPAIR SURGERY IN THE WRIST ON (B)(6) 2018 DEVELOPED IN (B)(6) 2019 PAIN IN THE LEFT WRIST. A BIOPSY WAS PERFORMED AND A FOREIGN BODY REACTION, PROBABLY CAUSED BY THE SUTURE WHICH IS ATTACHED TO THE ANCHOR, WAS IDENTIFIED. IT WAS FURTHER REPORTED THAT LYTIC AREAS (HOLES) HAVE BEEN FORMED AT THE SITE OF THE INSERTED ANCHOR WHICH MAY LEAD TO AN ARTHRITIS IN THE FUTURE. UPDATE 07-OCT-2020: FURTHER INFORMATION WAS PROVIDED THAT THE PAIN WAS FOUND ON (B)(6) 2019 AND THAT THE INITIAL SURGERY WAS ALSO PERFORMED BY THE SAME SURGEON. A FOLLOW UP SURGERY WAS PERFORMED ON (B)(6) 2019. THE SURGEON REMOVED THE SUTURE MATERIAL AND THE REMAINING FRAGMENTS OF THE ANCHOR. AN BIOPSY WAS DONE AND THE SAMPLES WERE SENT TO HISTOLOGY AND SHOWED THAT THE PATIENT HAD A TISSUE REACTION TO SOME FOREIGN MATERIAL. THE REACTION WAS MOST LIKELY CAUSED BY THE FIBERWIRE SUTURE AS TRACES OF THE SUTURE MATERIAL WERE FOUND IN THE MACROPHAGES. THE PATIENT HAD TO VISIT THE HOSPITAL AND SOME STIFFNESS IN THE WRIST ON FLEXION/EXTENSION REMAINED BUT PAIN WAS GONE AND THE PATIENT HAS BEEN DISCHARGED.

  Patient problems: Reaction

  MAUDE report 10666754 ↗
• InjuryOct 6, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 30 MONTHS AFTER A INITIAL SUCCESSFUL SCAPHOLUNATE LIGAMENT REPAIR FOR THE SCAPHOID AN LUNATE SIGNIFICANT LYSIS WAS FOUND AROUND BOTH SUTURETAKS, ESPECIALLY AROUND THE LUNATE ONE. THE SURGEON REPORTED IN ADDITION THAT AN OEDEMA IN THE CAPITATE BONE AND SIGNS OF OSTEOARTHRITIS IN THE MIDCARPAL BONES WERE IDENTIFIED WHICH WERE NOT EXPECTED FOLLOWING A SCAPHOLUNATE LIGAMENT REPAIR. THE SURGEON STATED THE ASSUMPTION THAT THE LYSIS AROUND THE SUTURETAKS IN THE SCAPHOID AND LUNATE HAS HAD A KNOCK-ON EFFECT WITH THE ADJACENT BONES. IT WAS FURTHER REPORTED THAT THE LIGAMENT REPAIR ITSELF LOOKED WELL. CURRENTLY IT IS UNKNOWN IF A REVISION SURGERY IS NECESSARY.

  Patient problems: No Code Available

  MAUDE report 10634180 ↗
• InjurySep 2, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ARTHREX MEXICO HAS BEEN NOTIFIED OF THE FOLLOWING INCIDENT: A PATIENT UNDERWENT AN ARTHROSCOPIC BROSTROM AND INTERNAL BRACE ANKLE PROCEDURE (B)(6) 2019. THE PATIENT PROGRESSED ERRONEOUSLY IN WOUND HEALING, SECONDARY TO REJECTION OF INTERNAL SUTURE MATERIAL, CAUSING INFECTION AND DESISTANCE ON (B)(6) 2020. PATIENT HAS BEEN UNDER ANTIBIOTIC TREATMENT SINCE WITH BIOMICS 400MG AND DANZEN 10MG. ON (B)(6) 2020 A FISTULECTOMY WAS PERFORMED IN THE SURGEON¿S OFFICE UNDER LOCAL ANESTHESIA, AS WELL AS WOUND REMODELING AND CLOSURE WITH DERMALON 3/0, WHICH WAS REJECTED AND (B)(6) 2020 A VACUUM THERAPY PEAK WOUND PATCH WAS PLACED TO PREVENT THE FORMATION OF SEROMA WHICH PREVENTS PROPER WOUND CLOSURE IN AN ATTEMPT TO AVOID A MAJOR SURGICAL PROCEDURE. AFTER 10 DAYS THE PATCH WAS REMOVED (B)(6) 2020 FINDING GRANULATION OF THE TISSUE, WITH BLEEDING EDGES AND PACACITY OF WOUND REMODELING WITH LITTLE EXUDATE. A CULTURE WAS PERFORMED OF THE SECRETION. LABORATORY SAMPLE RESULTS REPORTED STAPHYLOCOCCUS AUREUS. PATIENT IS SENSITIVE TO TRIMETHOPRIM WITH SULFAMETHOXAZOLE SO AN ORAL ADMINISTRATION WAS ADMINISTERED FOR 15 DAYS TO REMIT INFECTION SYMPTOMS. DUE TO WOUND CLOSURE NOT OCCURRIN

  Patient problems: Foreign Body Reaction; Impaired Healing; Purulent Discharge; Staphylococcus Aureus; Unspecified Infection

  MAUDE report 10484014 ↗
• InjurySep 2, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ARTHREX (B)(4) HAS BEEN NOTIFIED OF THE FOLLOWING INCIDENT: A PATIENT UNDERWENT AN ARTHROSCOPIC BROSTROM AND INTERNAL BRACE ANKLE PROCEDURE (B)(6) 2019. THE PATIENT PROGRESSED ERRONEOUSLY IN WOUND HEALING, SECONDARY TO REJECTION OF INTERNAL SUTURE MATERIAL, CAUSING INFECTION AND DESISTANCE ON (B)(6) 2020. PATIENT HAS BEEN UNDER ANTIBIOTIC TREATMENT SINCE WITH BIOMICS 400MG AND DANZEN 10MG. ON (B)(6) 2020 A FISTULECTOMY WAS PERFORMED IN THE SURGEON¿S OFFICE UNDER LOCAL ANESTHESIA, AS WELL AS WOUND REMODELING AND CLOSURE WITH DERMALON 3/0, WHICH WAS REJECTED AND (B)(6) 2020 A VACUUM THERAPY PEAK WOUND PATCH WAS PLACED TO PREVENT THE FORMATION OF SEROMA WHICH PREVENTS PROPER WOUND CLOSURE IN AN ATTEMPT TO AVOID A MAJOR SURGICAL PROCEDURE. AFTER 10 DAYS THE PATCH WAS REMOVED (B)(6) 2020 FINDING GRANULATION OF THE TISSUE, WITH BLEEDING EDGES AND PACACITY OF WOUND REMODELING WITH LITTLE EXUDATE. A CULTURE WAS PERFORMED OF THE SECRETION. LABORATORY SAMPLE RESULTS REPORTED STAPHYLOCOCCUS AUREUS. PATIENT IS SENSITIVE TO TRIMETHOPIN WITH SULFAMETHOXAZOLE SO AN ORAL ADMINISTRATION WAS ADMINISTERED FOR 15 DAYS TO REMIT INFECTION SYMPTOMS. DUE TO WOUND CLOSURE NOT OCCURRING

  Patient problems: Foreign Body Reaction; Impaired Healing; Purulent Discharge; Staphylococcus Aureus; Unspecified Infection

  MAUDE report 10483945 ↗
• InjurySep 2, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ARTHREX (B)(4) HAS BEEN NOTIFIED OF THE FOLLOWING INCIDENT:A PATIENT UNDERWENT AN ARTHROSCOPIC BROSTROM AND INTERNAL BRACE ANKLE PROCEDURE (B)(6) 2019. THE PATIENT PROGRESSED ERRONEOUSLY IN WOUND HEALING, SECONDARY TO REJECTION OF INTERNAL SUTURE MATERIAL, CAUSING INFECTION AND DESISTANCE ON (B)(6) 2020. PATIENT HAS BEEN UNDER ANTIBIOTIC TREATMENT SINCE WITH BIOMICS 400MG AND DANZEN 10MG. 7/13/2020 A FISTULECTOMY WAS PERFORMED IN THE SURGEON¿S OFFICE UNDER LOCAL ANESTHESIA, AS WELL AS WOUND REMODELING AND CLOSURE WITH DERMALON 3/0, WHICH WAS REJECTED AND (B)(6) 2020 A VACUUM THERAPY PEAK WOUND PATCH WAS PLACED TO PREVENT THE FORMATION OF SEROMA WHICH PREVENTS PROPER WOUND CLOSURE IN AN ATTEMPT TO AVOID A MAJOR SURGICAL PROCEDURE. AFTER 10 DAYS THE PATCH WAS REMOVED (B)(6) 2020 FINDING GRANULATION OF THE TISSUE, WITH BLEEDING EDGES AND PACACITY OF WOUND REMODELING WITH LITTLE EXUDATE. A CULTURE WAS PERFORMED OF THE SECRETION. LABORATORY SAMPLE RESULTS REPORTED STAPHYLOCOCCUS AUREUS. PATIENT IS SENSITIVE TO TRIMETHOPIN WITH SULFAMETHOXAZOLE SO AN ORAL ADMINISTRATION WAS ADMINISTERED FOR 15 DAYS TO REMIT INFECTION SYMPTOMS. DUE TO WOUND CLOSURE NOT OCCURRING

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Staphylococcus Aureus; Unspecified Infection

  MAUDE report 10483921 ↗
• InjuryJun 14, 2019Break

  IT WAS REPORTED DURING A BROSTROM PROCEDURE, AFTER DRILLING WITH A 1.8MM DRILL AND UPON INSERTING THE AR-1322BCNF SUTURE ANCHOR MINI BIOCOMPOSITE SUTURETAK, THE TIP OF THE ANCHOR BROKE. A SECOND AR-1322BCNF WAS BROUGHT IN AND BROKE UPON INSERTION AS WELL. THE THIRD AR-1322BCNF USED SEATED CORRECTLY. A SECOND LOCATION WAS THEN DRILLED WITH A 2.0MM DRILL AND THE FOURTH AR-1322BCNF WAS INSERTED, AND PULLED OUT. THE REP STATED A BONE TUNNEL WAS USED TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED ON 05/28/2019: THE REP REPORTED A TOTAL OF FOUR AR-1322BCNF FROM LOT 10216048 BROKE ABOUT HALFWAY DOWN THE ANCHOR BODY DURING INSERTION. THE REP CONFIRMED ALL IMPLANTS WERE REMOVED, AS THEY CAME OUT WHEN THE INSERTER WAS REMOVED. THE 5TH ANCHOR THAT WAS USED WAS SEATED CORRECTLY. THE IMPLANTS WERE BEING PUT INTO THE FIBULA. NO UNPLANNED INCISIONS WERE MADE. THE REP STATED BONE TUNNELS WERE USED TO COMPLETE THE REPAIR. THE FOUR COMPLAINT DEVICES WERE DISCARDED AFTER THE PROCEDURE, AND WILL NOT BE RETURNING FOR EVALUATION. ADDITIONAL INFORMATION RECEIVED ON 05/29/2019: THE REP CONFIRMED THERE WERE A TOTAL OF FIVE IMPLANTS USED AND FOUR MALFUNCTIONED. THE BONE QUALITY WAS HARD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8699403 ↗