Arthrex® AR-3770SPRecalls & reported problems

Summary

The FDA's MAUDE database contains 63 adverse event reports that list this exact device (DI 00888867428065), received between Sep 18, 2023 and Jul 30, 2026 — classified as 63 malfunctions.

The most frequently reported specific device problem is “Break” (13 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 63 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2026Material Twisted/Bent

  Patient problems: Insufficient Information

  MAUDE report 50082048 ↗
• MalfunctionJul 30, 2026Material Twisted/Bent

  Patient problems: Insufficient Information

  MAUDE report 50081880 ↗
• MalfunctionMar 31, 2026Positioning Failure

  IT WAS REPORTED THAT THE DEVICE DID NOT HOLD THE LIGAMENT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24740553 ↗
• MalfunctionFeb 18, 2026Positioning Failure

  ON 29-JAN-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-3770SP HYBRID KNEE FIBERTAK ANCHOR (KNOTLESS AND KNOTTED) EXHIBITED AN ISSUE WITH THE KNOTLESS MECHANISM. THE ANCHOR WAS DRILLED FOR AND IMPLANTED AFTER THE SURGEON HAD COMPLETED THE ACL RECONSTRUCTION. DURING USE, THE KNOTLESS MECHANISM WAS NOTED TO LOOSEN VERY EASILY AFTER CINCHING DOWN THE IT BAND, REQUIRING MINIMAL EFFORT FOR THE TENSION TO BE LOST. THIS WAS DISCOVERED DURING A LATERAL EXTRAARTICULAR TENODESIS PROCEDURE ON (B)(6) 2026, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 03-FEB-2026: THE ANCHOR AND SUTURES REMAIN IN THE PATIENT. THE CASE WAS COMPLETED USING THE AR-3770SP HYBRID KNEE FIBERTAK ANCHOR FROM THE SAME LOT. THERE WAS NO CASE DELAY AND NO ADDITIONAL ANESTHESIA ADMINISTERED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24378982 ↗
• MalfunctionFeb 18, 2026Positioning Failure

  ON 30-JAN-2026, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT (2) AR-3770SP HYBRID KNEE FIBERTAK® ANCHORS AND (2) AR-3740SP DOUBLE LOADED KNOTLESS KNEE FIBERTAK® ANCHORS BACKED OUT. THIS OCCURRED DURING AN MPFL RECONSTRUCTION ON (B)(6) 2026 WHEN ALL (4) DEVICES BACKED OUT OF THE PATIENT. THE PATIENT HAD VERY GOOD BONE QUALITY, WHICH WAS PREPPED USING AN AR-3712-29 2.9MM DRILL FOR KNEE FIBERTAKS. THESE FAILURES RESULTED IN A 15-MINUTE DELAY WHICH NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE PROCEDURE WAS COMPLETED USING AN AR-2324KBCC BIOCOMPOSITE KNOTLESS SWIVELOCK® ANCHOR, AND AN AR-3740SP DOUBLE LOADED KNOTLESS KNEE FIBERTAK® ANCHOR. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24376541 ↗
• MalfunctionFeb 18, 2026Positioning Failure

  ON 30-JAN-2026, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT (2) AR-3770SP HYBRID KNEE FIBERTAK® ANCHORS AND (2) AR-3740SP DOUBLE LOADED KNOTLESS KNEE FIBERTAK® ANCHORS BACKED OUT. THIS OCCURRED DURING AN MPFL RECONSTRUCTION ON (B)(6) 2026 WHEN ALL (4) DEVICES BACKED OUT OF THE PATIENT. THE PATIENT HAD VERY GOOD BONE QUALITY, WHICH WAS PREPPED USING AN AR-3712-29 2.9MM DRILL FOR KNEE FIBERTAKS. THESE FAILURES RESULTED IN A 15-MINUTE DELAY WHICH NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE PROCEDURE WAS COMPLETED USING AN AR-2324KBCC BIOCOMPOSITE KNOTLESS SWIVELOCK® ANCHOR, AND AN AR-3740SP DOUBLE LOADED KNOTLESS KNEE FIBERTAK® ANCHOR. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24376530 ↗
• MalfunctionFeb 9, 2026Break

  ON 20-JAN-2026, A DISTRIBUTOR REPORTED VIA EMAIL THAT AN AR-3770SP HYBRID KNEE FIBERTAK ANCHOR (KNOTLESS AND KNOTTED) EXPERIENCED AN ISSUE IN WHICH THE KNOTLESS MECHANISM BROKE WHILE TENSIONING. A REPLACEMENT ANCHOR WAS OPENED TO COMPLETE THE PROCEDURE. THIS WAS DISCOVERED DURING A LET PROCEDURE ON (B)(6) 2026, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED ON 22-JAN-2026.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24293331 ↗
• MalfunctionJan 26, 2026Break

  ON (B)(6) 2026, A DISTRIBUTOR REPORTED VIA EMAIL THAT AN AR-3770SP HYBRID KNEE FIBERTAK ANCHOR (KNOTLESS AND KNOTTED) EXPERIENCED A FORK BREAKAGE AFTER CONTACT WITH THE BONE. THE CASE WAS COMPLETED WITH A REPLACEMENT AR-3770SP HYBRID KNEE FIBERTAK ANCHOR (KNOTLESS AND KNOTTED) WITHOUT ISSUES. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2026, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 14-JAN-2026: ALL DETACHED FORK FRAGMENTS WERE RETRIEVED FROM THE PATIENT. THE ISSUE OCCURRED DURING A LET PROCEDURE. THE CASE WAS COMPLETED USING A REPLACEMENT AR-3770SP HYBRID KNEE FIBERTAK ANCHOR (KNOTLESS AND KNOTTED). THE PROCEDURE WAS DELAYED BY APPROXIMATELY TWO MINUTES, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. NO ADVERSE EFFECTS WERE REPORTED DURING OR FOLLOWING SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24176620 ↗
• MalfunctionJan 12, 2026Use of Device Problem

  ON 23-DEC-2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-3770SP HYBRID KNEE FIBERTAK ANCHOR (KNOTLESS AND KNOTTED) WAS FOUND TO HAVE A COMPROMISED BLUE LOOP AFTER IMPLANTATION INTO THE PATIENT¿S PATELLA. UPON UNWRAPPING THE SUTURE, IT WAS OBSERVED THAT THE BLUE LOOP HAD BEEN PACKAGED AND CUT IN HALF. A REPLACEMENT DEVICE WAS OPENED AND USED TO COMPLETE THE PROCEDURE. THE ISSUE OCCURRED DURING AN MPFL PROCEDURE ON (B)(6) 2025. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED ON 26-DEC-2025. ADDITIONAL INFORMATION WAS RECEIVED ON 29-DEC-2025: IT WAS REPORTED THAT THE PACKAGING WAS INTACT AND PROPERLY SEALED UPON OPENING. THE ISSUE WAS FIRST IDENTIFIED AFTER THE AR-3770SP HYBRID KNEE FIBERTAK ANCHOR HAD ALREADY BEEN IMPLANTED, WHEN THE COMPROMISED BLUE LOOP UNRAVELED FROM THE INSERTER HANDLE. THE COMPROMISED ANCHOR WAS SUBSEQUENTLY REMOVED FROM THE PATIENT. THE CASE WAS COMPLETED USING AN AR-2326BCC BIOCOMPOSITE SWIVELOCK. THE SURGERY EXPERIENCED A DELAY OF LESS THAN ONE MINUTE WHILE MOVING ON TO THE REPLACEMENT ANCHOR, AND LESS THAN ONE MINUTE OF ADDITIONAL ANESTHESIA WAS ADMINISTERED. ACCORDING TO THE SALES REPRESENTATIVE, THE IMPLANT WAS BROKEN FROM TH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24040136 ↗
• MalfunctionJan 5, 2026Break

  ON 16-DEC-2025, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT AN AR-3770SP HYBRID KNEE FIBERTAK ANCHOR EXPERIENCED AN ISSUE DURING USE. AFTER DRILLING A PILOT HOLE, THE ANCHOR WAS INSERTED TO THE SPECIFIED DEPTH. WHEN THE ANCHOR SHAFT WAS REMOVED, THE TIP OF THE SHAFT WAS FOUND TO BE BROKEN. THE BROKEN PIECE COULD NOT BE RETRIEVED. DESPITE THIS, THE ANCHOR FUNCTIONED WITHOUT FURTHER ISSUES AND WAS USED AS IS, ALLOWING THE PROCEDURE TO BE COMPLETED SUCCESSFULLY. NO SIGNIFICANT SURGERY DELAY WAS REPORTED, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THIS ISSUE WAS DISCOVERED DURING A LATERAL EPICONDYLE OF THE FEMUR STEP IN A KNEE EXTRATENDONOTOMY (LET) PROCEDURE ON (B)(6) 2025.

  Patient problems: Foreign Body In Patient

  MAUDE report 23960897 ↗
• MalfunctionDec 31, 2025Failure to Advance; Failure to Advance

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-3770SP HYBRID KNEE FIBERTAK ANCHOR FAILED DURING INSERTION. A PILOT HOLE WAS INITIALLY CREATED USING THE AR-3710, AND AN ATTEMPT WAS MADE TO INSERT THE ANCHOR; HOWEVER, THE INSERTION WAS UNSUCCESSFUL. A SECOND ANCHOR OF THE SAME MODEL WAS OPENED, AND A NEW PILOT HOLE WAS CREATED IN A DIFFERENT LOCATION FOLLOWING THE SAME PROCEDURE, BUT THE SAME FAILURE OCCURRED. THE PROCEDURE WAS COMPLETED USING ALTERNATIVE PRODUCTS WITH DIFFERENT PART NUMBERS, SPECIFICALLY THE AR-3641SP SELF-PUNCHING KNOTLESS 2.6 FIBERTAK. NO SIGNIFICANT SURGICAL DELAY WAS REPORTED. NOTHING REMAINED IN THE PATIENT, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THIS WAS DISCOVERED DURING A LATERAL EPICONDYLE OF THE FEMUR IN A PROCEDURE FOR LATERAL EXTRA-ARTICULAR TENDON FIXATION OF THE KNEE JOINT PROCEDURE ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23934692 ↗
• MalfunctionDec 31, 2025Failure to Advance; Failure to Advance

  ON (B)(6) 2025, IT WAS REPORTED BY AN ARTHREX SUBSIDIARY EMPLOYEE VIA EMAIL THAT AN AR-3770SP HYBRID KNEE FIBERTAK ANCHOR FAILED DURING INSERTION. A PILOT HOLE WAS INITIALLY CREATED USING THE AR-3710, AND AN ATTEMPT WAS MADE TO INSERT THE ANCHOR; HOWEVER, THE INSERTION WAS UNSUCCESSFUL. A SECOND ANCHOR OF THE SAME MODEL WAS OPENED, AND A NEW PILOT HOLE WAS CREATED IN A DIFFERENT LOCATION FOLLOWING THE SAME PROCEDURE, BUT THE SAME FAILURE OCCURRED. THE PROCEDURE WAS COMPLETED USING ALTERNATIVE PRODUCTS WITH DIFFERENT PART NUMBERS, SPECIFICALLY THE AR-3641SP SELF-PUNCHING KNOTLESS 2.6 FIBERTAK. NO SIGNIFICANT SURGICAL DELAY WAS REPORTED. NOTHING REMAINED IN THE PATIENT, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THIS WAS DISCOVERED DURING A LATERAL EPICONDYLE OF THE FEMUR IN A PROCEDURE FOR LATERAL EXTRA-ARTICULAR TENDON FIXATION OF THE KNEE JOINT PROCEDURE ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23934690 ↗
• MalfunctionDec 31, 2025Device Dislodged or Dislocated; Material Twisted/Bent; Device Dislodged or Dislocated; Material Twisted/Bent

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-3770SP HYBRID KNEE FIBERTAK SUTURE ANCHOR BENT DURING INSERTION. AS A RESULT, THE ANCHOR PULLED OUT BECAUSE IT WAS NOT INSERTED TO THE PROPER DEPTH (APPROXIMATELY 10 MM). THE SURGICAL PROCEDURE WAS DELAYED ONLY FOR A FEW MINUTES AND WAS COMPLETED USING ANOTHER AR-3770SP HYBRID KNEE FIBERTAK. THERE WERE NO ADVERSE EFFECTS TO THE PATIENT. THE IMPLANT WAS REMOVED FROM THE PATIENT. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THIS WAS DISCOVERED DURING A LET PROCEDURE ON (B)(6) 2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23933327 ↗
• MalfunctionDec 30, 2025Material Twisted/Bent; Material Twisted/Bent

  ON 04-DEC-2025, A DISTRIBUTOR REPORTED VIA EMAIL THAT AN AR-3770SP KNEE FIBERTAK HYBRID (ONE KNOTLESS AND ONE KNOTTED) HAD A BENT FORK UPON ANCHOR INSERTION. ANOTHER IMPLANT WAS OPENED AND FUNCTIONED PROPERLY. THIS OCCURRED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 18-DEC-2025: DURING A LET PROCEDURE, THE FORK ON THE INSERTER BENT, CAUSING THE INSTRUMENT TO CURVE BUT NOT BREAK. NO FRAGMENTS WERE GENERATED. THE CASE WAS COMPLETED USING ANOTHER AR-3770SP KNEE FIBERTAK HYBRID. THE ISSUE RESULTED IN AN APPROXIMATE TWO-MINUTE SURGICAL DELAY; NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING OR AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23923961 ↗
• MalfunctionDec 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 08-DEC-2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-3770SP HYBRID KNEE FIBERTAK ANCHOR MALFUNCTIONED DURING A PROCEDURE. AFTER IMPLANTATION, THE KNOTLESS LOOP WOULD NOT REDUCE. THE SURGEON ATTEMPTED TO RESOLVE THE ISSUE BUT ULTIMATELY REMOVED THE ANCHOR. THE CASE WAS COMPLETED SUCCESSFULLY BY INSERTING A NEW ANCHOR. THIS WAS DISCOVERED DURING A LET PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 15-DEC-2025: DURING THE PROCEDURE, THE ANCHOR PULLED OUT AFTER THE SUTURES FAILED TO SLIDE. THE SURGEON ATTEMPTED TO ADJUST THE SUTURES, WHICH CAUSED A BRIEF DELAY OF A FEW MINUTES. THE CASE WAS COMPLETED BY IMPLANTING ANOTHER AR-3770SP ANCHOR. NO ADDITIONAL ANESTHESIA WAS REQUIRED. THE BONE SOCKET WAS PREPARED USING AN AR-3711 DRILL, AND THE PATIENT WAS NOTED TO HAVE GOOD BONE QUALITY.

  Patient problems: Insufficient Information

  MAUDE report 23921524 ↗
• MalfunctionNov 19, 2025Use of Device Problem; Use of Device Problem

  ON 10/30/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT TWO AR-3770SP HYBRID KNEE FIBERTAK ANCHORS (KNOTLESS AND KNOTTED) EXPERIENCED LOOP BLUE SUTURE FAILURE DURING USE. THIS WAS DISCOVERED DURING A LET PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED ON 11/04/2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23593259 ↗
• MalfunctionNov 19, 2025Use of Device Problem; Use of Device Problem

  ON 10/30/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT TWO AR-3770SP HYBRID KNEE FIBERTAK ANCHORS (KNOTLESS AND KNOTTED) EXPERIENCED LOOP BLUE SUTURE FAILURE DURING USE. THIS WAS DISCOVERED DURING A LET PROCEDURE, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS REQUESTED ON 11/04/2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23593218 ↗
• MalfunctionOct 31, 2025Break; Break

  ON 10/24/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-3770SP HYBRID FIBERTAK BROKE DURING INSERTION. THE ANCHOR WAS REMOVED, SO THERE WERE NO ADVERSE EFFECTS ON THE PATIENT. THIS WAS DISCOVERED DURING AN MPFL PROCEDURE ON (B)(6) 2025. THE CASE WAS COMPLETED USING A SECOND HYBRID ANCHOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23435170 ↗
• MalfunctionOct 31, 2025Positioning Failure; Use of Device Problem; Positioning Failure; Use of Device Problem

  ON 10/22/2025, A DISTRIBUTOR REPORTED VIA EMAIL AN ISSUE INVOLVING THE AR-3770SP HYBRID KNEE FIBERTAK ANCHOR DURING AN MPFL RECONSTRUCTION PROCEDURE PERFORMED ON (B)(6) 2025. THE ANCHOR WAS IMPLANTED IN THE PATELLA. THE IMPLANT WAS INITIALLY SECURE, AND THE GRAFT WAS POSITIONED WITHIN THE BLUE LOOP. HOWEVER, WHILE THE GRAFT WAS INSERTED INTO THE FEMUR, ONE STRAND OF THE BLUE LOOP BROKE. THE BREAKAGE APPEARED TO OCCUR AT ONE EXTREMITY OF THE LOOP. ADDITIONALLY, THE SURGEON NOTED THAT THE BLUE LOOP OF A SECOND IMPLANT USED DURING THE SAME PROCEDURE SEEMED LOOSE. ADDITIONAL INFORMATION HAS BEEN REQUESTED ON 10/29/2025.

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

  MAUDE report 23434910 ↗
• MalfunctionOct 30, 2025Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED ON 11/3/2025: THE SECOND IMPLANT WITH THE LOOSE BLUE LOOP WAS ALSO AN AR-3770SP HYBRID KNEE FIBERTAK FROM THE SAME LOT NUMBER. IT WAS REPORTED THAT THE BLUE LOOP BROKE AND REMAINED INSIDE THE PATIENT ALONG WITH THE ANCHOR. ONLY THE BLACK SUTURES WERE REMOVED; THE END OF THE IMPLANT ITSELF STAYED IN THE PATIENT. THE CASE WAS COMPLETED USING PRODUCT PART NUMBER AR-2324KBCC BIOCOMPOSITE KNOTLESS SWIVELOCK. THE SURGERY WAS DELAYED BY APPROXIMATELY 30 MINUTES WHILE THE ISSUE WAS INVESTIGATED AND DETERMINED TO BE RELATED TO THE FIBERTAK. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED DURING OR FOLLOWING THE PROCEDURE DUE TO THIS ISSUE.

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

  MAUDE report 23427728 ↗
• MalfunctionMay 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 04/08/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT (QTY. 2) OF AN AR-3770SP KNEE FIBERTAK HYBRID (ONE KNOTLESS AND ONE KNOTTED) FAILED ON INSERTION AND PULLED OUT MULTIPLE TIMES. THE CASE WAS COMPLETED USING TWO AR-3770SP KNEE FIBERTAK HYBRIDS FROM LOT 15339225 WITHOUT ISSUES. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21971004 ↗
• MalfunctionMay 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS PROVIDED ON 5/22/2025: THIS ISSUE WAS IDENTIFIED DURING AN MPFL PROCEDURE. ALL AFFECTED COMPONENTS WERE REMOVED FROM THE PATIENT BEFORE PROCEEDING WITH THE NEW AR-3770SP KNEE FIBERTAK HYBRIDS. THERE WAS NO REPORTED CASE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21971003 ↗
• MalfunctionMay 1, 2025Material Frayed; Material Frayed

  ON 04/17/2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-3770SP HYBRID KNEE FIBERTAK ANCHOR (KNOTLESS AND KNOTTED), SELF-PUNCHING 2.6 MM, WAS NOTICED DURING INSERTION THAT THE SUTURES WERE LOADED INCORRECTLY AND SEVERED AND FRAYED. ALL DAMAGED SUTURES WERE REMOVED FROM THE PATIENT, AND THE CASE WAS COMPLETED WITH ANOTHER AR-3770SP FROM THE SAME LOT. THERE WAS NO CASE DELAY OR ADDED ANESTHESIA ADMINISTERED. THIS WAS DISCOVERED DURING AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21941978 ↗
• MalfunctionApr 28, 2025Positioning Failure; Defective Device; Positioning Failure; Defective Device

  THE CASE WAS COMPLETED USING ANOTHER AR-3770SP HYBRID KNEE FIBERTAK ANCHOR WITHOUT FURTHER IMPACTING THE PROCEDURE. THERE WAS NO DELAY, ADDITIONAL ANESTHESIA, OR FRAGMENTS REPORTED. NO FURTHER DETAILS WERE AVAILABLE OR PROVIDED REGARDING THE EVENT.

  Patient problems: Insufficient Information

  MAUDE report 21917133 ↗
• MalfunctionApr 2, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON 3/13/2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THREE AR-3770SP HYBRID KNEE FIBERTAK KNOTLESS MECHANISMS LOOSEN AFTER BEING TENSIONED ALL THE WAY DOWN AND CUT THE SUTURES. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS REQUESTED ON 3/31/2025.

  Patient problems: Foreign Body In Patient

  MAUDE report 21755172 ↗