Arthrex® AR-2658TRRecalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 00888867271814), received between Aug 20, 2018 and May 7, 2026 — classified as 8 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING THE CLAVICLE FRACTURE OPEN REDUCTION AND INTERNAL FIXATION SURGERY, THE SUTURE SNAPPED WHILE TIGHTENING THE TIGHTROPE. AS A RESULT, THE BUTTON HAD TO BE PULLED OUT FROM UNDER THE CORACOID. 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 25115874 ↗
• MalfunctionFeb 19, 2026Detachment of Device or Device Component

  ON 03-FEB-2026, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-2658TR KNOTLESS DISTAL CLAVICLE PLATE BUTTON TIGHTROPE HAD THE KNOTLESS CLAVICLE BUTTON DETACH FROM THE INSERTER ON THE FIRST ATTEMPT AND COULD NOT BE RETHREADED. THE ISSUE WAS IDENTIFIED DURING A CLAVICLE FRACTURE PROCEDURE ON (B)(6) 2026. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION WAS RECEIVED ON 10-FEB-2026: THE CASE WAS COMPLETED USING ANOTHER AR-2658TR KNOTLESS DISTAL CLAVICLE PLATE BUTTON TIGHTROPE. THE SURGERY EXPERIENCED A DELAY OF APPROXIMATELY 15 MINUTES DUE TO THE ISSUE. THE EVENT OCCURRED INSIDE THE PATIENT, NOT ON THE BACK TABLE. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE BUTTON AND SUTURES INVOLVED IN THE ISSUE WERE REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24392825 ↗
• MalfunctionDec 31, 2025Break; Break

  ON 04-DEC-2025, A SALES REPRESENTATIVE REPORTED VIA PHONE THAT THE BUTTON OF AN AR-2658TR KNOTLESS DISTAL CLAVICLE PLATE BUTTON TIGHTROPE BROKE OFF DURING INSERTION. ALL FRAGMENTS WERE RETRIEVED, AND THE PROCEDURE WAS COMPLETED USING A REPLACEMENT AR-2658TR FROM A DIFFERENT LOT. THE INCIDENT OCCURRED DURING A CLAVICLE ORIF PROCEDURE ON (B)(6) 2025 AND RESULTED IN AN APPROXIMATE 15-MINUTE DELAY. THE PATIENT¿S BONE QUALITY WAS REPORTED AS GOOD, AND A 3.7 MM GUIDE BUTTON PIN WAS USED FOR BONE PREPARATION PRIOR TO IMPLANT INSERTION. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23933983 ↗
• InjuryDec 1, 2025Use of Device Problem; Device Contaminated at the User Facility; Use of Device Problem; Device Contaminated at the User Facility

  IT WAS REPORTED THAT DURING A CLAVICLE FRACTURE AND AC JOINT SURGERY THE SURGEON DRILLED AND PLACED THE TIGHTROPE THROUGH THE CLAVICLE PLATE AND DIDN'T GET IT IN THE CORACOID PROCESS BONE. THE SURGEON PROCEEDED TO TAKE IT OUT AND DRILL AGAIN. THE BUTTON FLIPPED UNDER THE CLAVICLE WITHOUT THE CONTRAPTION THAT HOLDS EVERYTHING TOGETHER BEING TOUCHED AND THAT CONTRAPTION JUST CAME LOOSE, FELL ON THE GROUND AND WAS UNSTERILE. THE SURGEON HAD TO IMPROVISE TO MAKE A SYNDESMOSIS TIGHTROPE WORK WITH A LONG NEEDLE IN FRONT. PER COMPLAINT REPORTER THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY. IT WAS NOT NECESSARY TO DO A SECOND SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23682547 ↗
• MalfunctionNov 24, 2025Positioning Failure; Positioning Failure

  ON 07 NOVEMBER 2025, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2658TR, KNOTLESS DIS CLAV PLATE BUTTON TIGHTROP WAS REPORTED TO HAVE FAILED DURING INSERTION. THIS OCCURRED ON (B)(6) 2025 DURING A CLAVICLE ORIF. IT WAS REPORTED THAT THE PEC BUTTON SLIGHTLY "OFF CENTER" RELATIVE TO INSERTER OUT OF THE PACKET. HARD TO SAY IF IT WAS DAMAGED OR NOT SCREWED ON CORRECTLY. STILL ATTEMPTED TO USE, THOUGH BUTTON CAME OFF INSERTER AFTER PASSING THROUGH CLAVICLE AND BEFORE PASSING THROUGH COROCOID. THE CASE WAS COMPLETED SUCCESSFULLY USING A SECOND IMPLANT. THERE WAS CASE INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23631205 ↗
• MalfunctionNov 4, 2025Positioning Failure; Use of Device Problem; Positioning Failure; Use of Device Problem

  ADDITIONAL INFORMATION WAS RECEIVED ON 10/31/2025: DURING A CLAVICLE FRACTURE PROCEDURE ON (B)(6) 2025, AN ISSUE OCCURRED INVOLVING THE IMPLANT. THE ISSUE WAS DISCOVERED INSIDE THE PATIENT; HOWEVER, NO COMPONENTS FRACTURED OR REMAINED WITHIN THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A REPLACEMENT IMPLANT: AR-2658TR KNOTLESS DISTAL CLAVICLE PLATE BUTTON TIGHTROPE. THE SURGICAL CASE EXPERIENCED A BRIEF DELAY OF APPROXIMATELY FIVE MINUTES. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED AS A RESULT OF THE DELAY. FOR BONE PREPARATION PRIOR TO IMPLANT INSERTION, THE AR-2272 DRILL PIN BUTTON (3.7 MM) WAS UTILIZED. THE BONE QUALITY WAS ASSESSED AS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23467027 ↗
• MalfunctionOct 22, 2025Break; Break

  ON 10/10/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-2658TR KNOTLESS DISTAL CLAVICLE PLATE BUTTON TIGHTROPE EXPERIENCED AN ISSUE DURING INSERTION. SPECIFICALLY, THE BUTTON DETACHED FROM THE INSERTER AND FLIPPED BEFORE PASSING THROUGH THE CORACOID. THE BUTTON WAS SUCCESSFULLY EXPLANTED WITHOUT COMPLICATIONS; HOWEVER, AN ADDITIONAL IMPLANT HAD TO BE OPENED TO COMPLETE THE PROCEDURE. THIS OCCURRED DURING A DISTAL CLAVICLE FRACTURE WITH CC LIGAMENT REPAIR PERFORMED ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 10/15/2025: AN AR-2658TR KNOTLESS DISTAL CLAVICLE PLATE BUTTON TIGHTROPE WAS UTILIZED TO COMPLETE THE PROCEDURE. THE SURGERY EXPERIENCED A 5-MINUTE DELAY WHILE THE SURGEON ATTEMPTED TO PRESERVE AND RELOAD THE IMPLANT ONTO THE INSERTER. AFTER DETERMINING THAT THE TIGHTROPE COULD NOT BE SALVAGED, IT WAS REMOVED AND REPLACED WITH A NEW IMPLANT OF THE SAME PART NUMBER. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT DURING THIS DELAY. THE INSTRUMENT USED TO PREPARE THE BONE TUNNEL WAS THE AR-2272 (3.7 MM SPADE-TIP DRILL PIN). THE PATIENT'S BONE QUALITY WAS ASSESSED AS GOOD. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23360219 ↗
• MalfunctionAug 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ON (B)(6) 2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT AN AR-2658TR KNOTLESS DISTAL CLAVICLE PLATE BUTTON TIGHTROPE ENCOUNTERED AN ISSUE DURING USE. AFTER DRILLING SUPERIOR/INFERIOR THROUGH THE CLAVICLE PLATE, CLAVICLE, AND CORACOID USING A 3.7 MM DRILL PIN, AN INTRAOPERATIVE X-RAY REVEALED THAT THE BUTTON HAD DETACHED FROM THE INSERTER AND WAS LOCATED BETWEEN THE CLAVICLE AND CORACOID. THE SURGEON RETRIEVED THE BUTTON WITHIN APPROXIMATELY TWO MINUTES. THE SURGEON ATTEMPTED TO RETHREAD THE BUTTON ONTO THE INSERTER BUT WAS UNABLE TO ENGAGE THE THREADS. UPON INSPECTION, THE THREADED STYLET DID NOT PROTRUDE FAR ENOUGH TO THREAD INTO THE BUTTON PROPERLY. AS A RESULT, THE PROCEDURE CONTINUED WITHOUT SIGNIFICANT DELAY, AND THE FAULTY IMPLANT WAS DISCARDED AND REPLACED WITH A NEW AR-2658TR DEVICE. THE REPLACEMENT IMPLANT WAS SUCCESSFULLY DEPLOYED BENEATH THE CORACOID, ACHIEVING ADEQUATE REDUCTION OF THE AC JOINT. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2025, WITH NO REPORTED PATIENT HARM. ADDITIONAL INFORMATION WAS RECEIVED ON 07/30/2025: THIS OCCURRED DURING A CLAVICAL ORIF WITH AC JOINT REDUCTION ON (B)(6) 2025. THE BONE QUALITY WAS ASSESSED AS GOOD. NO PHOTOS OR VIDEOS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22771672 ↗
• MalfunctionNov 26, 2024Positioning Failure; Positioning Failure

  ON (B)(6) 2024 , IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-2658TR KNOTLESS DISTAL CLAVICLE PLATE BUTTON TIGHTROP SLIPPED AND CAME OFF THE DRIVER. CLAVICLE FRACTURE ON (B)(6) 2024 WHEN IMPLANTED AFTER PASSING THE CLAVICLE IT SLIPPED AND CAME OFF THE DRIVER. THE DEVICE WAS RETRIEVED AFTER 10-15 MINUTES. NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THE CASE WAS COMPLETED USING ANOTHER AR-2658TR. THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20789331 ↗
• MalfunctionOct 24, 2024Break; Break

  ON 10/7/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT THE BUTTON FROM AN AR-2658TR KNOTLESS DISTAL CLAVICLE PLATE BUTTON TIGHTROPE POPPED OFF THE INSERTER WHEN INSERTING THE TIGHTROPE. THE CASE WAS COMPLETED USING ANOTHER AR-2658TR KNOTLESS DISTAL CLAVICLE PLATE BUTTON TIGHTROPE. THE PATIENT WAS NOT AFFECTED. THIS WAS DISCOVERED DURING A KNOTLESS CLAVICLE BUTTON PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 10/14/2024: THIS WAS DISCOVERED DURING A CLAVICLE FRACTURE AND AC JOINT RECONSTRUCTION PROCEDURE. THE BUTTON POPPED OFF THE INSERTER WHEN INSERTING THE TIGHTROPE IN THE PATIENT. ALL FRAGMENTS WERE REMOVED. THE CASE WAS DELAYED ABOUT TWENTY MINUTES; HOWEVER, ADDITIONAL ANESTHESIA WAS NOT NEEDED.

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

  MAUDE report 20524003 ↗
• InjuryOct 16, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT TWO AR-2658TR KNOTLESS DISTAL CLAVICLE PLATE BUTTON TIGHTROPE WERE NOT FLIPPED ON THE TIGHTROPE. THIS WAS DISCOVERED DURING A CLAVICLE FRACTURE PROCEDURE ON (B)(6) 2024. THE CASE WAS COMPLETED BY OPENING AN ACUTE DOG BONE BUTTON KIT AND CREATING A DEEPER INCISION.

  Patient problems: Insufficient Information

  MAUDE report 20460579 ↗
• InjuryOct 16, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON 9/20/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT TWO AR-2658TR KNOTLESS DISTAL CLAVICLE PLATE BUTTON TIGHTROPE WERE NOT FLIPPED ON THE TIGHTROPE. THIS WAS DISCOVERED DURING A CLAVICLE FRACTURE PROCEDURE ON (B)(6) 2024. THE CASE WAS COMPLETED BY OPENING AN ACUTE DOG BONE BUTTON KIT AND CREATING A DEEPER INCISION.

  Patient problems: Insufficient Information

  MAUDE report 20460553 ↗
• MalfunctionSep 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 8/14/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT TWO AR-2658TR KNOTLESS DISTAL CLAVICLE PLATE BUTTON TIGHTROPE WERE UNSCREWED AND CAME OFF THE INSERTER WHILE IT WAS INSIDE THE PATIENT. THIS WAS DISCOVERED DURING A CLAVICLE FRACTURE WITH AC JOINT FIXATION PROCEDURE ON (B)(6) 2024. THE BUTTON WAS NOT IMPLANTED, AND THE CASE WAS COMPLETED BY STABILIZING THE CLAVICLE ONLY. THE CASE WAS DELAYED BETWEEN FIVE AND TEN MINUTES. EVERYTHING WAS SUCCESSFULLY REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20157347 ↗
• MalfunctionSep 6, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 8/14/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT TWO AR-2658TR KNOTLESS DISTAL CLAVICLE PLATE BUTTON TIGHTROPE WERE UNSCREWED AND CAME OFF THE INSERTER WHILE IT WAS INSIDE THE PATIENT. THIS WAS DISCOVERED DURING A CLAVICLE FRACTURE WITH AC JOINT FIXATION PROCEDURE ON (B)(6) 2024. THE BUTTON WAS NOT IMPLANTED, AND THE CASE WAS COMPLETED BY STABILIZING THE CLAVICLE ONLY. THE CASE WAS DELAYED BETWEEN FIVE AND TEN MINUTES. EVERYTHING WAS SUCCESSFULLY REMOVED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20157346 ↗
• MalfunctionJul 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ON 6/17/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-2658TR KNOTLESS DISTAL CLAVICLE PLATE BUTTON TIGHTROPE HAD THE BUTTON COME OFF THE INSERTER AFTER DRILLING WITH AN AR-2272 DRILL PIN BUTTON 3.7 MM THROUGH THE CLAVICLE. SUTURE AND BUTTON WERE REMOVED FROM THE PATIENT. THEN, AN AR-2372BLO KNOTLESS AC TIGHTROPE OPEN REPAIR IMPLANT WAS USED, AND IT PREMATURELY CAME OFF THE INSERTER. IT WAS CUT OUT, AND SUTURE AND BUTTON WERE REMOVED FROM THE PATIENT. THE CASE WAS COMPLETED USING AN AR-2658TR KNOTLESS DISTAL CLAVICLE PLATE BUTTON TIGHTROPE WITH NO ISSUES. THE CASE WAS DELAYED 45 MINUTES. IT IS UNKNOWN IF ADDITIONAL ANESTHESIA WAS ADMINISTERED TO THE PATIENT. NO ADVERSE EFFECTS ON THE PATIENT WERE REPORTED DUE TO THE ISSUE. THIS WAS DISCOVERED DURING A DISTAL CLAVICLE FRACTURE PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19700094 ↗
• MalfunctionJul 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS PROVIDED ON 06/18/2024 WHEN THE SALES REPRESENTATIVE STATED THAT THE BUTTONS HAD COME OFF BOTH DEVICES PREMATURELY. THEY WERE ABLE TO RETRIEVE THEM. THEY USED THE DRILL THAT CAME IN THE KIT TO PREPARE BOTH BONE TUNNELS. THE PATIENT HAD GOOD BONE QUALITY. THEY USED A CERCLAGE FIBER TAPE SUTURE TO PROCEED.

  Patient problems: Insufficient Information

  MAUDE report 19689787 ↗
• MalfunctionJul 5, 2024Positioning Failure; Positioning Failure

  ON 06/10/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06589273 THAT AN AR-2658TR KNOTLESS DISTAL CLAVICLE PLATE BUTTON TIGHTROPE®BUTTON RELEASED EARLY AFTER PASSING BI-CORTICALLY THROUGH THE CLAVICLE. THIS OCCURRED DURING A CLAVICLE REPAIR ON (B)(6) 2024, WHERE THE KNOTLESS DISTAL CLAVICLE PLATE BUTTON TIGHTROPE WAS CUT OUT AND REMOVED FROM THE PATIENT. THEY OPENED A NEW BUTTON TO FINISH THE REPAIR AND IT WORKED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 19683349 ↗
• MalfunctionJul 3, 2024Defective Device; Defective Device

  ON 06/7/2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2658TR KNOTLESS DISTAL CLAVICLE PLATE BUTTON TIGHTROPE WAS UNABLE TO BE USED IN THE PROCEDURE. THIS WAS DISCOVERED DURING A CLAVICLE FRACTURE REPAIR PROCEDURE ON (B)(6) 2024. THE CASE WAS COMPLETED USING ANOTHER AR-2658TR KNOTLESS DISTAL CLAVICLE PLATE BUTTON TIGHTROPE. ADDITIONAL INFORMATION WAS PROVIDED ON 06/13/2024, WHERE THE SALES REPRESENTATIVE STATED THEY WERE UNABLE TO RELOAD THE BUTTON ONTO THE INSERTER AFTER A FAILED ATTEMPT TO FLIP THE BUTTON AND COULDN'T FIGURE OUT WHY, RENDERING THE IMPLANT UNUSABLE. IT USUALLY ISN'T A PROBLEM TO RELOAD THE BUTTON. TO THEIR KNOWLEDGE, NOTHING BROKE THEY DIDN'T SEE ANYTHING UNDER FLUOROSCOPY. THE CASE CONTINUED USING A NEW TIGHTROPE. THE CASE WAS ONLY DELAYED A FEW MINUTES. NO ADDITIONAL ANESTHESIA WAS NECESSARY AND THERE WAS NO HARM TO THE PATIENT.

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

  MAUDE report 19664914 ↗
• MalfunctionJun 13, 2024Premature Activation; Premature Activation

  ON 4/26/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (2) PEC BUTTON'S FROM AN AR-2658TR KNOTLESS DISTAL CLAVICLE PLATE BUTTON TIGHTROPE DEPLOYED PREMATURELY IN THE INTRAMEDULLARY WITHIN THE CLAVICLE. BOTH TIMES THE SURGEON WAS ABLE TO REMOVE EVERYTHING FROM INSIDE THE PATIENT AND COMPLETE THE CASE SUCCESSFULLY WITH A THIRD AR-2658TR KNOTLESS DISTAL CLAVICLE PLATE BUTTON TIGHTROPE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 4/28/2023: THIS WAS DISCOVERED DURING AN ORIF OF A DISTAL CLAVICLE FRACTURE ON THE RIGHT SIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19531977 ↗
• MalfunctionJun 13, 2024Premature Activation; Premature Activation

  ON 4/26/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT (2) PEC BUTTON'S FROM AN AR-2658TR KNOTLESS DISTAL CLAVICLE PLATE BUTTON TIGHTROPE DEPLOYED PREMATURELY IN THE INTRAMEDULLARY WITHIN THE CLAVICLE. BOTH TIMES THE SURGEON WAS ABLE TO REMOVE EVERYTHING FROM INSIDE THE PATIENT AND COMPLETE THE CASE SUCCESSFULLY WITH A THIRD AR-2658TR KNOTLESS DISTAL CLAVICLE PLATE BUTTON TIGHTROPE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2023. ADDITIONAL INFORMATION RECEIVED ON 4/28/2023: THIS WAS DISCOVERED DURING AN ORIF OF A DISTAL CLAVICLE FRACTURE ON THE RIGHT SIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19531884 ↗
• MalfunctionJun 3, 2024Break; Break

  ON 10/29/2021, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-2658TR TIGHTROPE EYELET FELL OFF THE INSERTER BEFORE INSERTION. THE WAS DISCOVERED DURING AN AC JOINT RECONSTRUCTION ON (B)(6) 2021. THE CASE WAS COMPLETED BY USING A NEW AR-2658TB.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19447275 ↗
• MalfunctionMay 24, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  ON (B)(6) 2024, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT THE BUTTON FROM AR-8925SS SYNDESMOSIS TIGHTROPE XP BROKE OFF THE INSERTER. AN AR-2658TR KNOTLESS DISTAL CLAVICLE PLATE BUTTON TIGHTROPE DEPLOYED TOO EARLY. EVERYTHING WAS REMOVED FROM INSIDE THE PATIENT. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024. ADDITIONAL INFORMATION RECEIVED ON 4/30/2024: THIS WAS DISCOVERED DURING A CLAVICLE FX PROCEDURE. THE CASE WAS COMPLETED USING A NEW AR-8925SS SYNDESMOSIS TIGHTROPE XP. AR-2658TR KNOTLESS DISTAL CLAVICLE PLATE BUTTON TIGHTROPE CAME OFF THE INSERTER AND WAS STUCK UNDER THE CLAVICLE BUT WAS REMOVED WITHOUT ANY PROBLEM. ADDITIONAL ANESTHESIA WAS NOT NEEDED AS THE CASE WAS NOT DELAYED.

  Patient problems: Insufficient Information

  MAUDE report 19395413 ↗
• MalfunctionApr 26, 2024Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED ON 08/05/2022 BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-2664L DRILL GUIDE BROKE IN HALF. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM. ADDITIONALLY, AN AR-2658TR TIGHTROPE BECAME STUCK AND THE INSERTER WOULD NOT RELEASE. THIS WAS DISCOVERED DURING A CASE WITH NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19191427 ↗
• MalfunctionApr 22, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON 7/25/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-2658TR KNOTLESS DISTAL CLAVICLE PLATE BUTTON TIGHTROPE DID NOT SEAT PROPERLY AND PULLED OUT. SURGEON USED A DOG BONE TO COMPLETE THE CASE. THIS WAS DISCOVERED DURING A CLAVICLE FRACTURE WITH AC JOINT PROCEDURE ON (B)(6) 2022. CASE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER ISSUES.

  Patient problems: Insufficient Information

  MAUDE report 19154195 ↗
• MalfunctionApr 16, 2024Break; Break

  ON (B)(6) 2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT THE KNURLED STYLET BROKE INSIDE OF AR-2658TR KNOTLESS DISTAL CLAVICLE PLATE BUTTON TIGHTROPE, SNAPPING THE BUTTON OFF AS WELL. SURGEON OPENED ANOTHER AR-2658TR KNOTLESS DISTAL CLAVICLE PLATE BUTTON TIGHTROPE TO COMPLETE THE CASE WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED PRIOR TO INSERTION AND NOTHING BROKE INSIDE THE PATIENT, DURING A DISTAL CLAVICLE PROCEDURE ON (B)(6) 2022.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19117408 ↗