Arthrex® AR-1934BCFRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00888867023871), received between Aug 23, 2016 and Jul 24, 2025 — classified as 8 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2025Break; Break

  ON 2ND JULY 2025, IT WAS REPORTED BY AN ARTHREX'S EMPLOYEE VIA EMAIL THAT FOR AN AR-1934BCF, SUTURE ANCHOR, BIOCOMPOSITE SUTURETAK ® 3 X 14.5 MM WITH #2 FIBERWIRE®, ITS ANCHOR WAS BROKEN DURING INSERTION. THIS WAS DETECTED DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2025. THE CASE WAS COMPLETED SUCCESSFULLY BY USING ANOTHER BRAND PRODUCT. THERE WAS NO PATIENT HARM, AND NO SECONDARY PROCEDURE NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22589523 ↗
• MalfunctionJan 8, 2025Break; Break

  ON 11/6/2023, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-1934BCF BIOCOMPOSITE SUTURETAK ANCHOR BROKE DURING INSERTION. ALL THE BROKEN FRAGMENTS WERE RETRIEVED, AND THE CASE WAS COMPLETED USING ANOTHER AR-1934BCF BIOCOMPOSITE SUTURETAK. THIS WAS DISCOVERED DURING AN RCR PROCEDURE ON (B)(6) 2023.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21102966 ↗
• MalfunctionDec 30, 2024Break; Break

  ON 4TH DECEMBER 2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-1934BCF BIOCOMPOSITE SUTURETAK ANCHOR BROKE DURING INSERTION. THIS WAS DETECTED DURING AN EXPLORATORY LABOPLASTY OF HIP JOINT SURGERY ON (B)(6) 2024. AR-1927PB AND AR-2324PTB WAS USED TO PREPARE BONE SOCKET AND THE ANCHOR BROKE DURING INSERTION. ALL FRAGMENTS WERE RETRIEVED FROM PATIENT. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT HARM AND NO SECONDARY PROCEDURE NEEDED BY USING ANOTHER NEW AR-1934BCF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21036811 ↗
• MalfunctionOct 24, 2023Break; Break

  IT WAS REPORTED THAT DURING A MPFL KNEE SURGERY THE TIP OF THE ANCHOR BROKE OFF INSIDE THE PATIENT. THE BROKEN PIECES WERE 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 17996413 ↗
• InjuryAug 3, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 3.5 MONTHS AGO THE PATIENT, A TOP ATHLETE, UNDERWENT SURGERY DUE TO AN EXTENSIVE ANTERIOR/POSTERIOR/SUPERIOR LABRUM INJURY WHEREIN THE SURGEON UTILIZED FOUR (4) FAST-TAK BIOCOMPOSITE ANCHORS AND TWO (2) SWIVELOCK BIOCOMPOSITE ANCHORS TO COMPLETE THE PROCEDURE. WHEN THE SURGEON SAW THE PATIENT POST-OPERATIVELY EVERYTHING LOOKED NORMAL, WITHOUT ANY ISSUES. HOWEVER, AT THE MOST RECENT FOLLOW UP APPOINTMENT THE PATIENT HAD DEVELOPED A SERIOUS CONDITION (BLEEDING, CLOTS, ETC.). THE SURGEON REPORTED THAT IT WAS POSSIBLY DUE TO AN IMMUNOLOGICAL CONDITION. UPDATE 02-JUL-2020: THE SURGEON PROVIDED THE INFORMATION THAT THE PATIENT¿S ISSUES WERE MOST LIKELY CAUSED BY AN ACUTE CYTOMEGALY VIRUS. UPDATE 08-JUL-2020: IT WAS FURTHER REPORTED THAT THE SURGEON ACTUALLY UTILIZED FIVE (5) PUSHLOCKS, AR-1923PS (LOT10285636 - QTY 3 AND LOT 10263269 - QTY 2) AND THREE (3) SUTURETAKS, AR-1934BCF (LOTS: 10235880, 10294553, 10283790) DURING THE INITIAL SURGERY. UPDATE 13-JUL-2020: A PUBLISHED ARTICLE WAS FOUND WHICH STATED THAT THE PATIENT HAD BEEN HOSPITALIZED FOR TWO WEEKS AFTER FALLING ILL DURING TRAINING AND PASSED AWAY ON (B)(6) 2020. THE ARTICLE FURTHER DESCRIBED THAT PRIOR TO PAS

  Patient problems: Autoimmune Disorder; Death; Hemorrhage/Blood Loss/Bleeding; Thrombus

  MAUDE report 10358066 ↗
• InjuryAug 3, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 3.5 MONTHS AGO THE PATIENT, A TOP ATHLETE, UNDERWENT SURGERY DUE TO AN EXTENSIVE ANTERIOR/POSTERIOR/SUPERIOR LABRUM INJURY WHEREIN THE SURGEON UTILIZED FOUR (4) FAST-TAK BIOCOMPOSITE ANCHORS AND TWO (2) SWIVELOCK BIOCOMPOSITE ANCHORS TO COMPLETE THE PROCEDURE. WHEN THE SURGEON SAW THE PATIENT POST-OPERATIVELY EVERYTHING LOOKED NORMAL, WITHOUT ANY ISSUES. HOWEVER, AT THE MOST RECENT FOLLOW UP APPOINTMENT THE PATIENT HAD DEVELOPED A SERIOUS CONDITION (BLEEDING, CLOTS, ETC.). THE SURGEON REPORTED THAT IT WAS POSSIBLY DUE TO AN IMMUNOLOGICAL CONDITION. *** UPDATE 02-JUL-2020: THE SURGEON PROVIDED THE INFORMATION THAT THE PATIENT¿S ISSUES WERE MOST LIKELY CAUSED BY AN ACUTE CYTOMEGALY VIRUS. *** UPDATE 08-JUL-2020: IT WAS FURTHER REPORTED THAT THE SURGEON ACTUALLY UTILIZED FIVE (5) PUSHLOCKS, AR-1923PS (LOT10285636 - QTY 3 AND LOT 10263269 - QTY 2) AND THREE (3) SUTURETAKS, AR-1934BCF (LOTS: 10235880, 10294553, 10283790) DURING THE INITIAL SURGERY. *** UPDATE 13-JUL-2020: A PUBLISHED ARTICLE WAS FOUND WHICH STATED THAT THE PATIENT HAD BEEN HOSPITALIZED FOR TWO WEEKS AFTER FALLING ILL DURING TRAINING AND PASSED AWAY ON (B)(6) 2020. THE ARTICLE FURTHER DESCRIBED THAT

  Patient problems: Autoimmune Disorder; Death; Hemorrhage/Blood Loss/Bleeding; Thrombus

  MAUDE report 10358004 ↗
• InjuryAug 3, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 3.5 MONTHS AGO THE PATIENT, A TOP ATHLETE, UNDERWENT SURGERY DUE TO AN EXTENSIVE ANTERIOR/POSTERIOR/SUPERIOR LABRUM INJURY WHEREIN THE SURGEON UTILIZED FOUR (4) FAST-TAK BIOCOMPOSITE ANCHORS AND TWO (2) SWIVELOCK BIOCOMPOSITE ANCHORS TO COMPLETE THE PROCEDURE. WHEN THE SURGEON SAW THE PATIENT POST-OPERATIVELY EVERYTHING LOOKED NORMAL, WITHOUT ANY ISSUES. HOWEVER, AT THE MOST RECENT FOLLOW UP APPOINTMENT THE PATIENT HAD DEVELOPED A SERIOUS CONDITION (BLEEDING, CLOTS, ETC.). THE SURGEON REPORTED THAT IT WAS POSSIBLY DUE TO AN IMMUNOLOGICAL CONDITION. UPDATE 02-JUL-2020: THE SURGEON PROVIDED THE INFORMATION THAT THE PATIENT¿S ISSUES WERE MOST LIKELY CAUSED BY AN ACUTE CYTOMEGALY VIRUS. UPDATE 08-JUL-2020: IT WAS FURTHER REPORTED THAT THE SURGEON ACTUALLY UTILIZED FIVE (5) PUSHLOCKS, AR-1923PS (LOT10285636 - QTY 3 AND LOT 10263269 - QTY 2) AND THREE (3) SUTURETAKS, AR-1934BCF (LOTS: 10235880, 10294553, 10283790) DURING THE INITIAL SURGERY. UPDATE 13-JUL-2020: A PUBLISHED ARTICLE WAS FOUND WHICH STATED THAT THE PATIENT HAD BEEN HOSPITALIZED FOR TWO WEEKS AFTER FALLING ILL DURING TRAINING AND PASSED AWAY ON (B)(6) 2020. THE ARTICLE FURTHER DESCRIBED THAT PRIOR TO PAS

  Patient problems: Autoimmune Disorder; Death; Hemorrhage/Blood Loss/Bleeding; Thrombus

  MAUDE report 10358003 ↗
• InjuryMay 14, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE OPEN ANTERIOR BANKART REPAIR BEING PERFORMED WAS A REVISION FROM A PRIOR INSTABILITY REPAIR. DURING THE PROCEDURE, AFTER DEEP DISSECTION TO THE GLENOID RIM, THE SURGEON PLACED THE GUIDE FROM THE AR-3638DS FIBERTAK DISPOSABLE KIT ON THE GLENOID AND INTRODUCED THE AR-3600D-3 1.70MM DRILL THROUGH THE GUIDE AND BEGAN TO DRILL IN A STRAIGHT LINE FASHION. BEFORE THE DRILL COULD BOTTOM OUT IT LOOKED AS THOUGH THE DRILL ¿CAUGHT¿ AND THE SURGEON IMMEDIATELY STOPPED DRILLING. THE SURGEON PULLED THE DRILL GUIDE OFF THE BONE AND EVALUATED THE DRILL OUTSIDE THE PATIENT. THE DRILL HAD BENT SUCH THAT THE GUIDE WAS UNUSABLE BECAUSE THE DRILL HAD LODGED IN THE GUIDE. THE REP REPORTED THE SURGEON FOLLOWED THE TECHNIQUE AS THEY WALKED THEM THROUGH EACH STEP WITH THIS BEING THE SURGEON'S FIRST TIME USING THIS ANCHOR. ANOTHER DRILL GUIDE AND DRILL BIT WERE OPENED AND THE CASE WAS COMPLETED USING A FOUR DOUBLE LOADED SUTURETAPE FIBERTAKS. THE REP REPORTED THAT THE OUTCOME OF THE SURGERY WAS EXACTLY AS PLANNED. THE PATIENT HAD GOOD BONE QUALITY, AND GOOD TISSUE QUALITY. ADDITIONAL INFORMATION REQUESTED. ADDITIONAL INFORMATION RECEIVED ON 04/22/2020: THE REP REPORTED THE REASON FO

  Patient problems: Pain

  MAUDE report 10055629 ↗
• InjuryJan 20, 2020Break; Device Slipped

  IT WAS REPORTED WHILE USING THE DRILL WITHIN THE AR-3670 FIBERTAK BICEPS IMPLANT SET, THE DRILL BECAME STUCK IN THE GUIDE. THE REP REPORTED THE DRILL GUIDE SEEMED TO HAVE HAD A METAL BUR THAT CAUSED THE DRILL TO SEIZE UP AND SUBSEQUENTLY SNAP OFF IN THE DRILL GUIDE. A SECOND AR-3670 FROM THE SAME LOT WAS OPENED TO USE THE DRILL GUIDE FOR ANCHOR INSERTION, AND THE ANCHOR PULLED RIGHT BACK OUT. THE REP STATED THEY SUSPECT THAT THE HOLE DRILLED WAS ENLARGED FROM THE PROBLEM DURING THE DRILLING, AND THIS IS WHY THE ANCHOR PULLED OUT. A 3.5 SWIVELOCK WAS PLACED IN THE SAME HOLE AND PULLED OUT AS WELL. SURGEON WENT ON AND CREATED A BONY TUNNEL WITH SUTURE TO FINISH THE CASE. THE SALES REP REPORTED THERE WAS NO ADVERSE EVENT INVOLVED. ADDITIONAL INFORMATION RECEIVED ON 01/03/2020: THE PROCEDURE TAKING PLACE WAS AN MPFL, AND THE BONE QUALITY WAS HARD. THE DRILL BROKE OFF IN THE DRILL GUIDE, AND NO DEBRIS WERE PRODUCED. AN UNPLANNED INCISION WAS NOT NECESSARY. IT WAS REPORTED THAT A TOTAL OF TWO FIBERTAKS (WITHIN THE TWO COMPLAINT AR-3670 IMPLANT SETS), ONE AR-1934BCF SUTURETAK, AND ONE AR-2325BCC SWIVELOCK ALL PULLED OUT DURING THE SURGERY. THE SUTURETAK AND SWIVELOCK WERE PULLED FROM THE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9607426 ↗
• InjuryMar 24, 2017Break; Unstable

  IT WAS REPORTED THAT DURING A SHOULDER INSTABILITY CASE, THE 3.0 BIO-COMPOSITE SUTURETAK SUTURE ANCHOR, AR-1934BCF, BROKE OUT OF THE GLENOID NECK. THE SURGEON WAS ABLE TO REMOVE THE SUTURE MATERIAL HOWEVER, THE ANCHOR COULD NOT BE SEEN AS IT WAS ENVELOPED WITHIN THE CAPSULAR TISSUE. THE SURGEON FELT IT WAS TOO RISKY TO WORK MEDIALLY TO FIND IT. THEREFORE, THE ANCHOR WAS LEFT IMBEDDED WITHIN THE CAPSULAR TISSUE AND WAS NOT REMOVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6431384 ↗
• InjuryAug 23, 2016Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED BY THE PATIENT ON DAY OF THE REVISION PROCEDURE, (B)(6) 2016,THAT SHE HAD UNDERGONE AN ACL RECONSTRUCTION ON (B)(6) 2016 ON HER RIGHT LEG. ON (B)(6) 2016 THE PATIENT BEGAN TO NOTICE EXTREME SWELLING, KNEE WAS HOT TO THE TOUCH, SHE HAD A SKIN RASH WITH WELTS AND BURNING IN AND AROUND THE INCISION. THE REACTION ALSO SPREAD TO THE LATERAL SIDE OF THE FEMUR AND TIBIA. THE PATIENT HAD AN ER VISIT ON (B)(6) 2016 WHERE BLOODWORK WAS TAKEN. RESULTS WERE NEGATIVE FOR INFECTION. SURGEON DECIDED TO BRING PATIENT IN FOR SECOND SURGERY AND POSSIBLE REMOVAL OF THE IMPLANTS. PATIENT STATES THAT PRIOR TO THE (B)(6) 2016, PROCEDURE SHE HAD ALLERGY TESTING WHICH SHOWED THAT SHE WAS ALLERGIC TO NICKEL. THE FOLLOWING PARTS WERE IMPLANTED DURING THE ORIGINAL (B)(6) 2016 PROCEDURE: AR-1934BCF LOT 1240957 ((B)(6)), AR-1934BCF LOT 1240946 ((B)(6)), AR-2324BCC LOT 10025466 ((B)(6)) AND AR-5035TC-09 LOT 1314851 ((B)(6)). ON (B)(6) 2016 THE SURGEON REPORTED THAT DURING THE (B)(6) 2016 SECOND SURGERY, NO ARTHREX PRODUCTS WERE EXPLANTED. THE SURGEON PERFORMED A SYNOVECTOMY WITH IRRIGATION & DEBRIDEMENT. SURGEON STATED THAT THE REPAIR LOOKED GOOD. SURGEON STATES THAT THE PATIENT SYMPTOMS APPEARE

  Patient problems: Burning Sensation; Joint Swelling; Rash; Reaction

  MAUDE report 5897918 ↗
• InjuryAug 23, 2016Insufficient Device Problem Information

  IT WAS REPORTED BY THE PATIENT ON DAY OF THE REVISION PROCEDURE, (B)(6) 2016,THAT SHE HAD UNDERGONE AN ACL RECONSTRUCTION ON (B)(6) 2016 ON HER RIGHT LEG. ON (B)(6) 2016 THE PATIENT BEGAN TO NOTICE EXTREME SWELLING, KNEE WAS HOT TO THE TOUCH, SHE HAD A SKIN RASH WITH WELTS AND BURNING IN AND AROUND THE INCISION. THE REACTION ALSO SPREAD TO THE LATERAL SIDE OF THE FEMUR AND TIBIA. THE PATIENT HAD AN ER VISIT ON (B)(6) 2016 WHERE BLOODWORK WAS TAKEN. RESULTS WERE NEGATIVE FOR INFECTION. SURGEON DECIDED TO BRING PATIENT IN FOR SECOND SURGERY AND POSSIBLE REMOVAL OF THE IMPLANTS. PATIENT STATES THAT PRIOR TO THE (B)(6) 2016, PROCEDURE SHE HAD ALLERGY TESTING WHICH SHOWED THAT SHE WAS ALLERGIC TO NICKEL. THE FOLLOWING PARTS WERE IMPLANTED DURING THE ORIGINAL (B)(6) 2016 PROCEDURE: AR-1934BCF LOT 1240957 ((B)(4)), AR-1934BCF LOT 1240946 ((B)(4)), AR-2324BCC LOT 10025466 ((B)(4)) AND AR-5035TC-09 LOT 1314851 ((B)(4)). ON 8/12/2016 THE SURGEON REPORTED THAT DURING THE (B)(6) 2016 SECOND SURGERY, NO ARTHREX PRODUCTS WERE EXPLANTED. THE SURGEON PERFORMED A SYNOVECTOMY WITH IRRIGATION & DEBRIDEMENT. SURGEON STATED THAT THE REPAIR LOOKED GOOD. SURGEON STATES THAT THE PATIENT SYMPTOMS APPEARED

  Patient problems: Alteration In Body Temperature; Burning Sensation; Rash; Reaction; Swelling

  MAUDE report 5897902 ↗