Arthrex® AR-2372BLORecalls & reported problems

Summary

The FDA's MAUDE database contains 91 adverse event reports that list this exact device (DI 00888867340152), received between Apr 17, 2023 and Sep 30, 2026 — classified as 4 injuries, 87 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (33 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 25 most recent of 91 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026Positioning Failure

  On 14th September 2026, it was reported by an Arthrex employee via email that for an AR-2372BLO, Knotless AC TightRope® Open Repair Implant, the surgeon tightened the adjustment suture using standard procedures, but the last 5 mm would not tighten. The loop was cut, and the implant was removed. This was detected during use in an unknown procedure on (b)(6) 2026. The procedure was completed successfully as a new one was opened and the procedure was redone without any issues.No significant surgery delay reported. All of the product/fragment was removed, and nothing remains in the patient. No additional anesthesia administered to the patient. No information about an instrument used to prepare/tap the bone socket for insertion of the implant. Bone quality of the patient is unknown.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50948534 ↗
• MalfunctionJul 27, 2026Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50022529 ↗
• MalfunctionApr 10, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ACROMIOCLAVICULAR SEPARATION SURGERY THE BUTTON OF THE TIGHTROPE FELL FROM THE IMPLANT HOLDER AFTER PASSING THROUGH THE CLAVICLE TWICE. 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 24844815 ↗
• MalfunctionApr 10, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ACROMIOCLAVICULAR SEPARATION SURGERY THE BUTTON OF THE TIGHTROPE FELL FROM THE IMPLANT HOLDER AFTER PASSING THROUGH THE CLAVICLE TWICE. 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 24844573 ↗
• MalfunctionApr 8, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE SURGERY TO TREAT AN ACROMIOCLAVICULAR JOINT SEPARATION, THE BUTTON OF THE TIGHTROPE DETACHED FROM THE IMPLANT HOLDER AFTER PASSING THROUGH THE CLAVICLE AND BEFORE PASSING THROUGH THE ACROMION. NO FRAGMENTS REMAINED IN 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 24817083 ↗
• MalfunctionMar 19, 2026Failure to Advance

  ON 27-FEB-2026, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2372BLO KNOTLESS AC TIGHTROPE BUTTON COULD NOT BE IMPLANTED. DURING THE PROCEDURE, THE SURGEON WAS UNABLE TO DRILL A SINGLE BONE TUNNEL THROUGH THE CLAVICLE AND CORACOID DUE TO THE NATURE OF THE PATIENT¿S BONE DISLOCATION. AS A RESULT, THE SURGEON ELECTED TO DRILL SEPARATE HOLES IN THE BONE AT DIFFERENT ANGLES. WHEN ATTEMPTING TO IMPLANT THE KNOTLESS AC TIGHTROPE DEVICE, THE DEVICE COULD NOT BE ADVANCED THROUGH THE SEPARATELY CREATED BONE HOLES, AS THE CONSTRUCT COULD NOT PASS THROUGH THIS TRAJECTORY. THE CASE WAS COMPLETED USING AN AR-2371BL KNOTLESS AC TIGHTROPE REPAIR SYSTEM INSTEAD. THIS ISSUE WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2026.

  Patient problems: Insufficient Information

  MAUDE report 24641702 ↗
• MalfunctionMar 19, 2026Detachment of Device or Device Component

  ON 27-FEB-2026, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-2372BLO KNOTLESS AC TIGHTROPE BUTTON CAME OFF DURING INSERTION. THE SURGEON ATTEMPTED TO DEPLOY THE BUTTON MULTIPLE TIMES, BUT IT WOULD NOT GRIP AND DETACHED IMMEDIATELY. THE SURGERY WAS COMPLETED USING ANOTHER AR-2372BLO KNOTLESS AC TIGHTROPE DEVICE. THIS ISSUE WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2026. NO SIGNIFICANT SURGICAL DELAY WAS REPORTED, AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING OR AFTER THE PROCEDURE RELATED TO THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24640529 ↗
• MalfunctionMar 12, 2026Use of Device Problem

  IT WAS REPORTED THAT DURING THE ACROMIOCLAVICULAR JOINT REPAIR, THE BUTTON OF THE FIRST AR-2372BLO (15500856) DID NOT FLIP AND THE BUTTON WAS PULLED OUT. THE SECOND AR-2372BLO (15474037) HAVE A FAILURE WITH THE SHAFT, SO THEY COULD NOT INSERT THE BUTTON. THEY USED A DIFFERENT SHAFT FROM ANOTHER AR-2372BLO TO INSERT THE BUTTON. 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 24580338 ↗
• MalfunctionMar 12, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING THE ACROMIOCLAVICULAR JOINT REPAIR, THE BUTTON OF THE FIRST AR-2372BLO (15500856) DID NOT FLIP AND THE BUTTON WAS PULLED OUT. THE SECOND AR-2372BLO (15474037) HAVE A FAILURE WITH THE SHAFT, SO THEY COULD NOT INSERT THE BUTTON. THEY USED A DIFFERENT SHAFT FROM ANOTHER AR-2372BLO TO INSERT THE BUTTON. 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 24578538 ↗
• MalfunctionFeb 3, 2026Positioning Failure; Physical Resistance/Sticking

  ON (B)(6) 2026, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT AN AR-2372BLO KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLANT WITH PEC BUTTON WOULD NOT TENSION AND FAILED TO ACHIEVE AC JOINT REDUCTION. THE SURGEON ULTIMATELY CUT AND REMOVED THE IMPLANT AND TIED THE GRAFT OVER THE CONSTRUCT. THE CASE WAS DELAYED APPROXIMATELY FIVE MINUTES, WITH NO ADDITIONAL ANESTHESIA ADMINISTERED. THE ISSUE OCCURRED DURING A CLAVICLE ORIF AND AC JOINT STABILIZATION PROCEDURE WITH INTERNAL OPEN REDUCTION PERFORMED ON (B)(6) 2026. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24251816 ↗
• MalfunctionDec 31, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ACROMIOCLAVICULAR (AC) JOINT SURGERY IN THREE IMPLANTS AR-2372BLO (LOT: 15474037, 15464005 AND 15446460) THE BUTTON DETACHED UNDER THE CLAVICLE DURING INSERTION. ALL PARTS OF THE DEVICES WERE RETRIEVED 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 23933032 ↗
• MalfunctionDec 31, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ACROMIOCLAVICULAR (AC) JOINT SURGERY IN THREE IMPLANTS AR-2372BLO (LOT: 15474037, 15464005 AND 15446460) THE BUTTON DETACHED UNDER THE CLAVICLE DURING INSERTION. ALL PARTS OF THE DEVICES WERE RETRIEVED 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 23933003 ↗
• MalfunctionDec 31, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ACROMIOCLAVICULAR (AC) JOINT SURGERY IN THREE IMPLANTS AR-2372BLO (LOT: 15474037, 15464005 AND 15446460) THE BUTTON DETACHED UNDER THE CLAVICLE DURING INSERTION. ALL PARTS OF THE DEVICES WERE RETRIEVED 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 23932892 ↗
• InjuryDec 9, 2025Positioning Failure; Positioning Failure

  UPDATE 28-JAN-2025: IT WAS FURTHER REPORTED AS CLARIFICATION THAT THE TIGHTROPE THREADS ABOVE THE BUTTON WERE NOT PULLED THROUGH EACH OTHER. THE LOOP WAS ON THE LEFT SIDE AND THE TWO THREADS ON THE RIGHT WERE NOT PULLED THROUGH THE LOOP. THE CUSTOMER FURTHER CONFIRMATION THAT THE REPORTED DEVICE WAS DISCARDED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 23756111 ↗
• MalfunctionNov 26, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT DURING A SURGERY THE IMPLANT DID NOT HOLD. NO FURTHER INFORMATION RECEIVED. UPDATE DW 20-NOV-2025: FURTHER INFORMATION WAS PROVIDED THAT THE FIRST ARTHREX EMPLOYEE BECAME AWARE OF THIS ISSUE ON 28TH OCTOBER 2025. IT WAS FURTHER REPORTED THAT THE ISSUE OCCURRED DURING A SHOULDER SURGERY. 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 DW 21-NOV-2025: FURTHER INFORMATION WAS PROVIDED THAT THE REPORTED DEVICE HAS THE BATCH 15446460.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23657357 ↗
• MalfunctionNov 26, 2025Break; Break

  ON 11/6/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT THE THREADED PORTION OF THE INSERTER FOR AN AR-2372BLO KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLANT BROKE OFF IN THE BUTTON PRIOR TO INSERTION. THE IMPLANT WAS DISCARDED BECAUSE IT COULD NOT BE ADVANCED THROUGH THE CLAVICLE OR CORACOID WITHOUT SLIPPING OFF THE INSERTER. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT, AND THE CASE PROCEEDED WITHOUT DELAY. THIS WAS DISCOVERED DURING AN AC JOINT RECONSTRUCTION PROCEDURE ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 11/12/2025: THE FAILED AR-2372BLO KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLANT WAS REMOVED FROM THE PATIENT, AND A REPLACEMENT AR-2372BLO KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLANT (FROM LOT: 15204430) WAS USED AFTER THE INITIAL FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23656256 ↗
• MalfunctionNov 5, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT DURING A SHOULDER SURGERY THE SHAFT GOT BENT AND COULD NOT BE PUSHED 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23478449 ↗
• MalfunctionSep 8, 2025Positioning Failure; Detachment of Device or Device Component; Positioning Failure; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED ON 9/8/2025: ALTHOUGH THE BUTTON FAILED TO HOLD THE REDUCTION, NOTHING BROKE INSIDE THE PATIENT. THE CASE EXPERIENCED A 10-MINUTE DELAY; HOWEVER, ADDITIONAL ANESTHESIA WAS NOT NEEDED.

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

  MAUDE report 22993046 ↗
• MalfunctionAug 21, 2025Premature Activation; Premature Activation

  ON 08/05/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT (2) AR-2372BLO KNOTLESS AC TIGHTROPE® OPEN REPAIR IMPLANTS PEC BUTTON DEPLOYED TOO EARLY BOTH TIMES. THIS OCCURRED DURING USE.

  Patient problems: Insufficient Information

  MAUDE report 22859834 ↗
• MalfunctionAug 21, 2025Premature Activation; Premature Activation

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA SEMS-07010204 THAT (2) AR-2372BLO KNOTLESS AC TIGHTROPE® OPEN REPAIR IMPLANTS PEC BUTTON DEPLOYED TOO EARLY BOTH TIMES. THIS OCCURRED DURING USE.

  Patient problems: Insufficient Information

  MAUDE report 22859806 ↗
• MalfunctionAug 4, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 07/15/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT (3) AR-2372BLO KNOTLESS AC TIGHTROPE® OPEN REPAIR IMPLANTS BUTTON CAME OFF THE INSERTER BEFORE PASSING THROUGH THE CORACOID. THIS OCCURRED DURING A CASE ON (B)(6) 2025. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 22701982 ↗
• MalfunctionAug 4, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 07/15/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT (3) AR-2372BLO KNOTLESS AC TIGHTROPE® OPEN REPAIR IMPLANTS BUTTON CAME OFF THE INSERTER BEFORE PASSING THROUGH THE CORACOID. THIS OCCURRED DURING A CASE ON (B)(6) 2025. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 22701980 ↗
• MalfunctionAug 4, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 07/15/2025, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT (3) AR-2372BLO KNOTLESS AC TIGHTROPE® OPEN REPAIR IMPLANTS BUTTON CAME OFF THE INSERTER BEFORE PASSING THROUGH THE CORACOID. THIS OCCURRED DURING A CASE ON (B)(6) 2025. THERE WAS NO ADDITIONAL INFORMATION PROVIDED, AND ADDITIONAL INFORMATION HAS BEEN REQUESTED.

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

  MAUDE report 22701979 ↗
• MalfunctionJul 22, 2025Positioning Failure; Positioning Failure

  ON 06/30/2025, AN ARTHREX SUBSIDIARY EMPLOYEE REPORTED VIA EMAIL THAT AN AR-2372BLO KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLANT HAD THE BUTTON FLIPPED OVER WHEN THE TIP OF THE PRODUCT WENT PAST THE COLLARBONE. THE ITEM WAS REMOVED FROM THE BODY. THE CASE WAS COMPLETED USING ANOTHER AR-2372BLO KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLANT. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 07/09/2025: THIS ISSUE OCCURRED DURING AN AC REPAIR PROCEDURE ON (B)(6) 2025. NO PIECES OF THE FAILED IMPLANT WERE LEFT IN THE PATIENT. AN AR-2272 DRILL PIN BUTTON 3.7 MM WAS USED TO PREPARE THE BONE SOCKET FOR THE IMPLANT'S INSERTION, AND THE PATIENT'S BONE QUALITY WAS ASSESSED AS HARD. NO CASE DELAY OR ADDED ANESTHESIA WAS ADMINISTERED. NO ADVERSE EFFECTS WERE REPORTED ON OR AFTER SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22568530 ↗
• MalfunctionJul 14, 2025Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE SUTURE OF THE DEVICE TORE. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY REPORTED. NO FURTHER INFORMATION RECEIVED. UPDATE AVOE 25-JUN-2025: IT WAS CONFIRMED THAT THE ERROR OCCURRED DURING AN OPEN ANTERIOR CRUCIATE LIGAMENT SURGERY. 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 22494998 ↗