Arthrex® AR-1926BCRecalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00888867023239), received between Nov 21, 2019 and Sep 24, 2026 — classified as 5 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Break

  On (b)(6) 2026, it was reported by a Facility Representative via Phone that an AR-1926BC Suture Anchor, BioComposite PushLock had a tip of the metal inserter break off in the anchor. It was reported that the broken piece appeared stuck in the anchor, and the surgeon deemed it safe and was not able to remove the broken fragment from the patient. This was discovered during a Shoulder Arthroscopy Rotator Cuff Repair procedure with no procedural delay experienced and no additional anesthesia administered.

  Patient problems: Foreign Body In Patient

  MAUDE report 50882037 ↗
• MalfunctionNov 13, 2025Break; Break

  ON 10/22/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN ANCHOR BREAKAGE OCCURRED DURING THE REPAIR PROCEDURE INVOLVING AR-1923BC BIOCOMPOSITE PUSHLOCK SUTURE ANCHORS (2.9 X 15.5 MM). UPON ARRIVAL AT THE FACILITY, IT WAS NOTED THAT ITEMS WERE MISSING IN THE SURGICAL KIT, SPECIFICALLY COMPONENTS REQUIRED FOR THE TRACTION TOWER. ONCE THE ISSUE WAS RESOLVED AND THE SURGERY COMMENCED, THE REPORTING TECHNICIAN ASSISTED WITH INSTRUMENTING THE PROCEDURE. THE PERFORATIONS WERE PERFORMED BY A MEDICAL RESIDENT, WHILE THE SURGEON INSERTED THE ANCHORS. THE FIRST ANCHOR BROKE DUE TO INCORRECT ALIGNMENT DURING INSERTION. A SECOND ANCHOR WAS PLACED CORRECTLY AND REMAINED INTACT. DESPITE CONFIRMING THE MATERIAL WAS APPROPRIATE FOR USE, SUBSEQUENT ANCHORS CONTINUED TO BREAK DURING INSERTION. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT, AND THE CASE WAS COMPLETED WITH ANOTHER PRODUCT. THIS WAS DISCOVERED DURING A LEFT SHOULDER ARTHROSCOPY FOR BANKART AND HILL-SACHS LESIONS, ALONG WITH A BANKART INSTABILITY REPAIR PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 10/28/2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23547088 ↗
• MalfunctionAug 18, 2025Break; Break

  ON 31ST JULY 2025, IT WAS REPORTED BY DISTRIBUTOR THAT FOR 1 UNIT OF AR-1927BCF-45, 4.5 MM BIOCOMPOSITE-CORKSCREW® FT SUTURE ANCHOR WITH ONE #2 FIBERWIRE® A ND ONE TIGERWIRE®, AND 1 UNIT OF AR-1926BC, SUTURE ANCHOR, BIOCOMPOSITE PUSHLOCK® 3.5 X 19,5 MM, BOTH THEIR ANCHOR BROKE WHILE BEING ROTATED BY THE SURGEON. THIS WAS DETECTED DURING A ROTATOR CUFF REPAIR ON (B)(6) 2025. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPLACING TO NEW ANCHOR. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22827883 ↗
• MalfunctionMay 8, 2025Break; Break

  IT WAS REPORTED THAT DURING A TROCHLEOPLASTY SURGERY THE ANCHOR FELL APART WHEN HAMMERING IN. 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) ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED THAT ALL BROKEN PARTS WERE RETRIEVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21986102 ↗
• MalfunctionSep 6, 2024Break; Break

  ON (B)(6) 2024, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-1926BC BIOCOMPOSITE PUSH LOCK SCREW BROKE DURING INSERTION. ALL THE BROKEN FRAGMENTS WERE REMOVED, AND THE CASE WAS COMPLETED USING A NEW AR-1926BC BIOCOMPOSITE PUSHLOCK. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2024. THE CASE AS NOT DELAYED, AND ADDITIONAL ANESTHESIA WAS NOT NEEDED. THE PATIENT SUFFERED NO NEGATIVE EFFECTS ON OR AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20156184 ↗
• MalfunctionApr 26, 2024Defective Device; Defective Device

  ON (B)(6) 2022 IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-19021TT TISSUE TAK TENDON ANCHOR DURING A ROTATOR CUFF SHOULDER PROCEDURE MALFUNCTIONED AND TORE THE GRAFT. THE GRAFT HAD TO BE REMOVED AND REPLACED. ALL OF THE IMPLANTS WERE IMPLANTED PROPERLY AND REMAIN IN THE PATIENT . ANOTHER GRAFT WAS USED AND THE TENDON ANCHOR WAS REPLACED. ADDITIONAL IMPLANTS WERE USED TO COMPLETE THE CASE SUCCESSFULLY. THE PATIENT TO FINE TO DATE WITH NO AFFECT.

  Patient problems: Foreign Body In Patient

  MAUDE report 19194237 ↗
• InjuryFeb 12, 2024Biocompatibility; Biocompatibility

  ADDITIONAL INFORMATION RECEIVED ON 2/2/2024: THIS WAS DISCOVERED AFTER AN ARTHROSCOPIC RCR, SUBACROMIAL DECOMPRESSION, AND LABRUM LIMITED DEBRIDEMENT PROCEDURE ON (B)(6) 2023. THE PATIENT EXPERIENCED RASHES, HIVES, REDNESS, AND ITCHINESS. THE REACTION WAS NOT LOCALIZED AT THE SURGICAL SITE; IT BEGAN UNDER THE ARM, LATER SPREADING TO THE CHEST AND OPPOSITE EXTREMITIES. THE REACTION WAS IDENTIFIED APPROXIMATELY ONE-WEEK POST-OPERATION. THE PATIENT WENT TO URGENT CARE AND WAS GIVEN CLOTRIMAZOLE, WHICH SLIGHTLY WORSENED THE REACTION. THE PATIENT TRIED HYDROCORTISONE OINTMENT AND TOOK PREDNISONE AND ZYRTEC. THE REACTION CONTINUED, AND THE PATIENT MADE SEVERAL TRIPS TO URGENT CARE. THE PATIENT RECEIVED FIFTY MILLIGRAMS OF BENADRYL INJECTIONS AT LEAST THREE TIMES DURING URGENT CARE VISITS. THE PATIENT WAS ALSO TREATED WITH XOLAIR DURING ONE OF THE URGENT CARE VISITS. THE PATIENT CONSULTED WITH A DERMATOLOGIST AND WAS PRESCRIBED ALLEGRA WITH ZYRTEC. THE PATIENT CONTINUES TO TAKE PREDNISONE AND HYDROXYZINE PAMOATE. THE PATIENT WILL BE CONSULTING AN ALLERGIST. ALL THE IMPLANTS REMAIN IN THE PATIENT.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 18686763 ↗
• MalfunctionNov 15, 2023Break; Break

  IT WAS REPORTED THAT DURING A GLENOID LABRUM SURGERY, THE DEVICE BROKE. 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. NO FURTHER INFORMATION WAS PROVIDED. UPDATE JK 17-OCT-2023: DURING A GLENOID LABRUM SURGERY, THE ANCHORS BROKE. UPDATE JK 19-OCT-2023: THE ANCHORS BROKE DURING INSERTION. IT WAS STATED THAT ALL BROKEN PARTS WERE SUCCESFULLY REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18142686 ↗
• MalfunctionNov 15, 2023Break; Break

  IT WAS REPORTED THAT DURING A GLENOID LABRUM SURGERY, THE DEVICE BROKE. 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. NO FURTHER INFORMATION WAS PROVIDED. UPDATE JK 17-OCT-2023: DURING A GLENOID LABRUM SURGERY, THE ANCHORS BROKE. UPDATE JK 19-OCT-2023: THE ANCHORS BROKE DURING INSERTION. IT WAS STATED THAT ALL BROKEN PARTS WERE SUCCESFULLY REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18142605 ↗
• MalfunctionNov 15, 2023Break; Break

  IT WAS REPORTED THAT DURING A GLENOID LABRUM SURGERY THE DEVICE BROKE. 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. NO FURTHER INFORMATION WAS PROVIDED. UPDATE (B)(6) 2023: DURING A GLENOID LABRUM SURGERY, THE ANCHORS BROKE. UPDATE (B)(6) 2023: THE ANCHORS BROKE DURING INSERTION. IT WAS STATED THAT ALL BROKEN PARTS WERE SUCCESSFULLY REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18138935 ↗
• InjuryAug 28, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE HOSPITAL CONTACTED THE SALES REP BECAUSE A PATIENT HAS AN ALLERGIC REACTION TO BIOCOMPOSITE MATERIAL. UPDATE SWIT 10-AUG-2023: THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2022. ON (B)(6) 2022 IT WAS AWARE THAT THE ALLERGY IS CAUSED BY THE DEVICE. THE SYMPTOMS OF THE ALLERGY ARE ITCHING AND SLIGHT REDNESS ON THE SHOULDER. NO SECOND SURGERY IS PLANNED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 17637410 ↗
• MalfunctionJun 23, 2023Break; Break

  ON 6/02/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-1926BC SUTURE ANCHOR BROKE WHEN INSERTED INTO THE TIBIA DURING AN ACL FIBULA SURGERY. THE BROKEN FRAGMENTS WERE RETRIEVED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17189756 ↗
• InjuryAug 24, 2020Material Rupture; Device Fell

  AN ARTHREX EMPLOYEE HAS REPORTED THAT AFTER THE SUCCESSFUL MENISCUS ROOT FIXATION THE SURGEON WANTED TO KNOT THE BUTTON ON THE BONE. THE BUTTON FELL INTO THE DRILL HOLE. THE SURGEON THEN TRIED TO REFIXATE THE SUTURE WITH A PUSH LOCK BUT IT RUPTURED. THE SURGEON WAS THEN ABLE TO FINISH THE SURGERY SUCCESSFULLY WITH A DIFFERENT TECHNIQUE AND AN ADDITIONAL SWIVELOCK. HOWEVER THE SURGEON WAS NOT ABLE TO RETRIEVE THE LOST BUTTON OUT OF THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10443237 ↗
• InjuryDec 2, 2019Entrapment of Device; Material Split, Cut or Torn

  IT WAS REPORTED DURING A SLAP REPAIR PROCEDURE, A QUANTITY THREE AR-1926BC SUTURE ANCHOR BIO-COMPOSITE PUSHLOCKS LOT: 10322845 MALFUNCTIONED. THE BONE TUNNEL WAS DRILLED USING AR-1912 (DRILL FOR 3.5 MM PUSHLOCK) AND AR-1909R (OFFSET GUIDE FOR 3.5 MM PUSHLOCK). THE DRILL WAS CYCLED 4-5 TIMES EACH TIME, AND THE ANCHOR WAS INSERTED AT THE SAME ANGLE OF DRILLING. WHILE THE ANCHORS WERE BEING INSERTED, THE LEADING EDGE OF THE PUSHLOCKS BEGAN TO SPLIT IN HALF AND EXIT OUT OF THE BONE TUNNEL LEAVING ONLY HALF OF THE ANCHOR IN THE BONE TUNNEL FOR FIXATION. THE PORTION OF THE ANCHOR THAT CURLED OUT OF THE BONE TUNNEL WAS RETRIEVED WITH GRASPERS AND DISPOSED OF. THE REMAINING PORTIONS OF THE THREE ANCHORS THAT STAYED IN THE BONE TUNNEL WERE SECURED, AND LEFT IMPLANTED. THE BONE QUALITY WAS NORMAL, AND WAS NOT ABNORMALLY HARD OR SOFT. IT WAS REPORTED THAT A SECOND SURGERY IS NOT NEEDED. THE REP REPORTED THERE WAS NO ADDITIONAL OR UNPLANNED INCISIONS / PORTALS MADE. THE IMPLANTS WERE BEING PLACED INTO THE GLENOID RIM FOR SLAP REPAIR. ONCE THE ANCHOR WAS FULLY SEATED, THE PUSHLOCK HANDLE WAS TWISTED AND REMOVED, THE ANCHOR PORTION THAT EXITED THE BONE TUNNEL WAS RETRIEVED FROM THE PATIENT AND D

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9396540 ↗
• InjuryNov 21, 2019Break; Material Split, Cut or Torn

  IT WAS REPORTED DURING A SLAP REPAIR PROCEDURE, A TOTAL OF SIX AR-1926BC SUTURE ANCHOR BIO-COMPOSITE PUSHLOCKS (LOT: 10316272 / QTY. 3 AND LOT: 10322845 / QTY. 3) MALFUNCTIONED. THE BONE TUNNEL WAS DRILLED USING AR-1912 (DRILL FOR 3.5MM PUSHLOCK) AND AR-1909R (OFFSET GUIDE FOR 3.5MM PUSHLOCK). THE DRILL WAS CYCLED 4-5 TIMES EACH TIME, AND THE ANCHOR WAS INSERTED AT THE SAME ANGLE OF DRILLING. FIVE OUT OF THE SIX AR-1926BC BROKE UPON INSERTION. WHILE THE ANCHORS WERE BEING INSERTED, THE LEADING EDGE OF THE PUSHLOCKS BEGAN TO SPLIT IN HALF AND EXIT OUT OF THE BONE TUNNEL LEAVING ONLY HALF OF THE ANCHOR IN THE BONE TUNNEL FOR FIXATION. THE PORTION OF THE ANCHOR THAT CURLED OUT OF THE BONE TUNNEL WAS RETRIEVED WITH GRASPERS AND DISPOSED OF. THE REMAINING PORTIONS OF THE FIVE ANCHORS THAT STAYED IN THE BONE TUNNEL WERE SECURED, AND LEFT IMPLANTED. THE SIXTH AR-1926BC (LOT: 10316272) SPLIT BEFORE BEING IMPACTED WITH THE MALLET, UPON THE ANCHOR BECOMING FLUSH WITH THE BONE. THIS ANCHOR WAS FULLY REMOVED, AND WILL BE RETURNING FOR EVALUATION (SEE ATTACHED IMAGE OF DEVICE). THE BONE QUALITY WAS NORMAL, AND WAS NOT ABNORMALLY HARD OR SOFT. IT WAS REPORTED THAT A SECOND SURGERY IS NOT NEEDED.

  Patient problems: No Code Available

  MAUDE report 9353290 ↗