Arthrex® AR-3780SPRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00888867431669), received between Aug 26, 2024 and May 27, 2026 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2026Break

  IT WAS REPORTED THAT DURING THE PECTORALIS REPAIR SURGERY, THE SUTURE PULL-THROUGH MECHANISMS SNAPPED AFTER THE ANCHOR HAD BEEN INSERTED. THE DAMAGED IMPLANT WAS REMOVED FROM THE PATIENT. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25298937 ↗
• MalfunctionFeb 16, 2026Device Dislodged or Dislocated

  ON 28-JAN-2026, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-3750SP KNEE FIBERTAK ANCHOR FOR THE INTERNALBRACE AND AN AR-3780SP KNEE FIBERTAK BUTTON BOTH PULLED OUT OF THE BONE AND DID NOT ACHIEVE FIXATION. BOTH DEVICES WERE REMOVED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A REPLACEMENT AR-3750SP KNEE FIBERTAK ANCHOR AND AN AR-1593-P SECONDARY FIXATION WITH PEEK SWIVELOCK ANCHOR IMPLANT SYSTEM. NO SURGICAL DELAY OR ADDITIONAL ANESTHESIA WAS REQUIRED. THIS EVENT OCCURRED DURING A DISTAL MCL PROCEDURE PERFORMED ON (B)(6) 2026, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24344896 ↗
• MalfunctionDec 22, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ON 12/01/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-1288RTT2-IBS AND AN AR-3780SP MALFUNCTIONED DURING THE CASE. THE TIGHTROPE FEATURE OF THE PRODUCT AR-1288RTT2-IBS RIPPED DURING TENSIONING OF THE GRAFT INTO THE FEMORAL TUNNEL. THE GRAFT HAD TO BE PULLED OUT AND RE-PREPPED USING PRODUCT: AR-1588RTT2-IB. DURING THE SAME CASE, ONE OF THE SUTURE LIMBS OF PRODUCT: AR-3780SP TORE OFF, RENDERING THE IMPLANT UNUSABLE. THIS WAS DISCOVERED DURING THE CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23865317 ↗
• MalfunctionDec 3, 2025Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 11/12/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3780SP KNEE FIBERTAK BUTTON WOULD NOT ALLOW THE SUTURES TO SHUTTLE THROUGH THE ANCHOR. THE ANCHOR WAS USED WITH AN AR-3710 DISPOSABLES KIT AND 1.3 SUTURETAPE EXACTLY AS INTENDED; HOWEVER, THE SUTURES WOULD NOT SHUTTLE AT ALL. THE ANCHOR WAS DRILLED OUT AND REPLACED. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 11/17/2025: THE EVENT OCCURRED DURING A DISTAL BICEPS REPAIR PROCEDURE ON (B)(6) 2025. THE CASE WAS COMPLETED USING A REPLACEMENT AR-3780SP KNEE FIBERTAK BUTTON. THE PROCEDURE WAS DELAYED TO REMOVE THE INITIAL ANCHOR AND INSERT A NEW ONE. THE EXACT DURATION OF THE DELAY AND WHETHER ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT REMAIN UNCERTAIN.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23705625 ↗
• MalfunctionAug 29, 2025Break; Use of Device Problem; Break; Use of Device Problem

  ON 08/12/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT TWO DEVICE ISSUES OCCURRED DURING A QUADRICEPS TENDON REPAIR PROCEDURE PERFORMED ON (B)(6) 2025. FIRST, AN AR-3780SP KNEE FIBERTAK BUTTON FAILED WHEN THE SUTURES COULD NOT BE PASSED THROUGH THE ANCHOR. WHILE ATTEMPTING TO PASS THE FIBERLINK SUTURE, IT BROKE, PREVENTING ANY SUTURE CONVERSION WITHIN THE ANCHOR. THE SUTURE WAS REMOVED, BUT THE ANCHOR REMAINED INTACT IN THE BONE AND WAS LEFT IN THE PATIENT. SECOND, AN AR-2326BCC BIOCOMPOSITE SWIVELOCK ANCHOR MALFUNCTIONED WHEN THE EYELET PREMATURELY DETACHED FROM THE INSERTION HANDLE DURING IMPLANTATION. THE THREAD ON THE EYELET WAS STRIPPED IN THE PROCESS. THE FAILED EYELET WAS SUCCESSFULLY REMOVED FROM THE PATIENT. THE CASE WAS COMPLETED USING AN AR-5511-CP INTERNALBRACE KNEE LIGAMENT AUGMENTATION REPAIR IMPLANT SYSTEM. THE PROCEDURE WAS DELAYED BY LESS THAN 15 MINUTES. IT IS UNKNOWN WHETHER ADDITIONAL ANESTHESIA WAS ADMINISTERED. BONE PREPARATION WAS PERFORMED USING AN AR-3710, AND THE PATIENT¿S BONE QUALITY WAS ASSESSED AS HARD. NO ADVERSE EFFECTS WERE REPORTED DURING OR AFTER SURGERY.

  Patient problems: Foreign Body In Patient

  MAUDE report 22923600 ↗
• MalfunctionAug 6, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-3780SP KNEE FIBERTAK BUTTON EXPERIENCED AN ISSUE DURING A TRICEPS REPAIR PROCEDURE ON (B)(6) 2025. AFTER IMPLANTATION AND REMOVAL FROM THE INTRODUCER, IT WAS NOTED THAT ONE OF THE SHUTTLING SUTURES WAS LACERATED, COMPROMISING THE ABILITY TO SHUTTLE THE SUTURE SUCCESSFULLY THROUGH THE IMPLANT. DESPITE THE ISSUE, THE CASE WAS COMPLETED, AND NO PATIENT HARM WAS REPORTED. NO FURTHER DETAILS PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON 07/28/2025: THE ISSUE WITH THE AR-3780SP KNEE FIBERTAK BUTTON WAS NOT NOTICED UNTIL AFTER IMPLANTATION. A BACKUP ANCHOR, THE AR-3780SP KNEE FIBERTAK BUTTON, WAS USED TO COMPLETE THE PROCEDURE, RESULTING IN A BRIEF 5-MINUTE DELAY WITHOUT EXTRA ANESTHESIA. BONE SOCKET PREPARATION WAS PERFORMED WITH THE AR-3710 KIT USING A 2.6 MM DRILL. BONE QUALITY WAS NORMAL, AND NO POST-OP COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22730543 ↗
• InjuryJun 2, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 5/14/2025, A HEALTHCARE PROFESSIONAL REPORTED THAT AN AR-3780SP KNEE FIBERTAK BUTTON, AN AR-8979P DX SWIVELOCK, AND AN AR-7500 SUTURETAPE WERE IMPLANTED IN A PATIENT DURING A SURGICAL PROCEDURE. APPROXIMATELY ONE YEAR LATER, THE PATIENT BEGAN EXPERIENCING PERSISTENT PAIN AND WAS REFERRED TO AN ALLERGIST FOR AN ALLERGEN PATCH TEST. NO ADDITIONAL DETAILS WERE PROVIDED.

  Patient problems: Pain

  MAUDE report 22125597 ↗
• MalfunctionOct 23, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 10/09/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA (B)(4) THAT AN AR-3780SP KNEE FIBERTAK® BUTTON PULLED OUT. THIS OCCURRED DURING USE WHEN THEY PLACED THE ANCHOR, THEY WENT TO SET THE ANCHOR AND IT PULLED OUT INSTANTLY. THE INSERTER ALSO BENT.

  Patient problems: Insufficient Information

  MAUDE report 20515529 ↗
• MalfunctionOct 9, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED ON 10/4/2024: THE BROKEN FRAGMENT OF THE DRILL WAS LARGE ENOUGH TO FISH OUT OF THE SOCKET CREATED IN THE HUMERUS ALONG WITH ALL COMPONENTS OF THE FIBERTAK. THE CASE WAS DELAYED FIVE TO TEN MINUTES WITHOUT ADDITIONAL ANESTHESIA.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20408722 ↗
• MalfunctionAug 26, 2024Break; Break

  ON 08/01/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-3780SP KNEE FIBERTAK® BUTTONS STITCHES BROKE. THIS OCCURRED DURING A QUAD TENDON REPAIR ON (B)(6) 2024 WHEN THEY WERE SHUTTLING THE TAPES THE STITCHES BROKE. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THE CASE WAS COMPLETED USING AN AR-2324PSLC SWIVELOCK. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20065609 ↗