Arthrex® AR-1588TBRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888867019621), received between Sep 19, 2018 and Dec 19, 2023 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 19, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  ON 11/17/2023, IT WAS REPORTED BY A PATIENT VIA PHONE THAT IN (B)(6) 2023, THE PATIENT UNDERWENT REVISION SURGERY TO HAVE AN AR-1588TB TIGHTROPE BUTTON REMOVED DUE TO AN ALLERGIC REACTION. THE PATIENT WAS EXPERIENCING SWELLING AND PAIN. THE ORIGINAL PROCEDURE TOOK PLACE ON (B)(6) 2018. THE PATIENT IS STILL HAVING ISSUES WITH THE KNEE AND WILL NEED A KNEE REPLACEMENT. THE PATIENT WOULD LIKE TO KNOW THE MATERIAL COMPOSITION OF THE TIGHTROPE BUTTON THAT WAS REMOVED DURING THE REVISION SURGERY. THE PATIENT DID NOT HAVE FURTHER INFORMATION TO PROVIDE.

  Patient problems: Foreign Body Reaction

  MAUDE report 18360198 ↗
• MalfunctionOct 6, 2023Use of Device Problem; Defective Device; Use of Device Problem; Defective Device

  ON 09/8/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS-06026021 THAT (2) AR-1588BTB-IB TIGHTROPE II BTB, AND AN AR-1588TB TIGHTROPE BUTTON FAILED. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION REQUESTED.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 17887508 ↗
• InjuryJan 30, 2023Contamination; Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ON 1/9/2023, IT WAS REPORTED BY AN ARTHREX EMPLOYEE VIA EMAIL THAT A PATIENT WAS ADMITTED DUE TO A DISLOCATION OF THE RIGHT ACROMIOCLAVICULAR JOINT ON (B)(6) 2022. ON (B)(6) 2022 AN INTERNAL FIXATURE PROCEDURE TOOK PLACE. TWO AR-1588RT TIGHTROPE RT WERE IMPLANTED DURING THE PROCEDURE. SHORTLY AFTER THE PROCEDURE, PATIENT COMPLAINT OF PAIN IN THE RIGHT ARM AND AFTER SURGEON EXAMINED THE WOUND, IT WAS FOUND WITH SECRETION. THE SUTURES WERE REMOVED, AND A CULTURE WAS SENT OUT FOR BACTERIAL INFECTION AND DRUG SENSITIVITY TEST. THE CULTURE SHOWS PATIENT HAD A STAPHYLOCOCCUS AUREUS INFECTION AND WAS TREATED WITH LEVOFLOXACIN AND GENTAMICIN SULFATE ANTIBIOTIC VIA INTRAVENOUS. ON (B)(6)2022, PATIENT REPORTED PAIN RELIEF AND THERE WAS NO OBVIOUS EXUDATION FROM THE WOUND. PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2022. DURING THE PROCEDURE, IT WAS NOTICED THAT THE PLATE WAS LOOSEN AND A SMALL NUMBER OF INFLAMMATORY CELLS AND PURULENT SECRETIONS WERE ALSO FOUND IN THE WOUND. AFTER CLEANING UP THE INFLAMMATORY CELLS AND PURULENT SECRETIONS, THE PURULENT WHITE SUBSTANCES WERE FOUND AROUND THE TITANIUM PLATE WITH LOOP AND THE LINE JUNCTION, WHICH WAS DETERMINED TO BE LINE JUNCTION REJECTION

  Patient problems: Bacterial Infection; Drug Resistant Bacterial Infection; Pain

  MAUDE report 16263901 ↗
• InjuryMay 23, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AFTER HAVING AN ACL RECONSTRUCTION WITH BIOCOMPOSITIE SCREW FIXATION PERFORMED ON (B)(6) 2018, THE PATIENT PROCEEDED TO HAVE CYSTIC CHANGES AROUND WHERE THE AR-1400C, BIOCOMPOSITE INTERFERENCE SCREW 10 X 23MM (LOT: 10153856) WAS IMPLANTED. THE CYSTIC CHANGES CREATED A 20MM WIRE TUNNEL, AND THE PATIENT RE-RUPTURED THEIR ACL. THERE WAS NO WIDENING AT THE APERTURE AND THE ANTERIOR CORTEX OF THE TIBIA. THE WIDENING OCCURRED ONLY IN THE MIDDLE PART OF THE TUNNEL, WHERE THE SCREW WAS PRESENT. THE FOLLOWING ARTHREX PARTS WERE USED DURING THE ORIGINAL PROCEDURE THAT TOOK PLACE ON (B)(6) 2018: AR-1204AF-95 // LOT: 735379685 // QTY.: 1. AR-1370C // LOT: 10179054 // QTY.: 1. AR-1390C // LOT: 10140550 // QTY.: 1. AR-1400C // LOT: 10153856 // QTY. 1. AR-1588TB // LOT: 10081396 // QTY.: 1. AR-1897S // LOT: 10172069 // QTY.: 1. AR-1981-08S // LOT: 734579451 // QTY.: 1. AR-4005B-18 // LOT: E1617 // QTY.: 1. AR-4005B-18 // LOT: E5955 // QTY.: 1. AR-7209SN // LOT: 18669 // QTY.: 1. AR-7235T // LOT: 10183941 // QTY.: 1. A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2019 BY THE SAME SURGEON WHO PERFORMED THE ORIGINAL, AND TOOK PLACE AT A DIFFERENT FACILITY. AR-1400C (LOT: 10153856) WAS

  Patient problems: Cyst(s); Osteolysis; Rupture

  MAUDE report 8636917 ↗
• InjurySep 19, 2018Break; Entrapment of Device; Material Twisted/Bent

  IT WAS REPORTED THAT THE AR-12990, KNEE SCORPION HAS A BROKEN NEEDLE PIECE WITHIN THE DEVICE ITSELF THAT CANNOT BE REMOVED. THIS OCCURRED DURING A REVISION MENISCAL ROOT REPAIR. THE REP STATED THAT THERE WERE THREE SCORPION NEEDLES USED. THE FIRST SCORPION NEEDLE BROKE UPON INSERTION. THE SURGEON WENT TO DEPLOY THE NEEDLE, AND A LOUD AUDIBLE CLICK OCCURRED. IT WAS THEN DISCOVERED THAT THE NEEDLE BROKE. AN X-RAY WAS TAKEN AND CONFIRMED THAT THERE WERE NOT ANY FRAGMENTS LEFT IN THE PATIENT. THE SECOND NEEDLE BENT, AND WAS NOT FIRING APPROPRIATELY. THE SURGEON DRY FIRED THE SECOND NEEDLE, AND IN DOING SO, THERE WAS RESISTANCE. UPON DRY FIRING THE SECOND NEEDLE, IT WAS DISCOVERED THAT THE AR-12990, KNEE SCORPION HAD A BROKEN PIECE WITHIN THE DEVICE. THE SURGEON DECIDED TO BRING IN A THIRD SCORPION NEEDLE AND A REPLACEMENT AR-12990. AS THE SURGEON WAS GETTING READY TO PROCEED, THE SURGEON DECIDED THAT THE PATIENT WAS NOT A GOOD CANDIDATE FOR THE REVISION MENISCAL ROOT REPAIR. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION RECEIVED ON 09/05/2018: THE REP CONFIRMED THAT THE PATIENT HAD AN ACL RECONSTRUCTION WITH MENISCAL ROOT REPAIR ON (B)(6) 2018. AFTER THE SURGERY THE

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7889008 ↗