Arthrex® AR-1898SRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00888867022461), received between Mar 1, 2017 and Jun 25, 2024 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 25, 2024Break; Break

  ON 05/30/2024 AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. A FACILITY REPRESENTATIVE REPORTED THAT THE GUIDE PIN FROM AN AR-1898S TRANSTIBIAL ACL DISPOSABLES KIT BROKE DURING THE PROCEDURE. THIS WAS DISCOVERED DURING A PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 19604534 ↗
• MalfunctionFeb 19, 2024Break; Break

  ON 1/24/2024, AN FDA MEDWATCH NOTIFICATION WAS RECEIVED VIA EMAIL. AN ANONYMOUS NURSE REPORTED THAT THE GUIDEWIRE FROM AN AR-1898S TRANSTIBIAL ACL DISPOSABLES KIT WAS NOTED TO BE BROKEN INTO TWO PIECES DURING THE PROCEDURE. ALL THE BROKEN FRAGMENTS WERE REMOVED WITH NO APPARENT INJURY. THIS WAS DISCOVERED DURING A LEFT ARTHROSCOPIC ACLR PROCEDURE ON (B)(6) 2024.

  Patient problems: Insufficient Information

  MAUDE report 18730283 ↗
• InjuryJul 6, 2021Material Fragmentation

  IT WAS REPORTED VIA THE PATIENT'S LEGAL REPRESENTATIVE THAT THE FOLLOWING INCIDENT OCCURRED: ON (B)(6) 2018, THE PATIENT UNDERWENT A RIGHT KNEE ARTHROSCOPY WITH ARTERIAL CRUCIATE LIGAMENT (¿ACL¿) RECONSTRUCTION, PARTIAL MEDIAL MENISCECTOMY, CHONDROPLASTY AND DEBRIDEMENT. DURING THE SURGERY, IT IS ALLEGED THAT ARTHREX¿S AR-1898S TRANSTIBIAL ACL DISPOSABLE KIT WAS UTILIZED ALONG WITH ANOTHER MANUFACTURERS FIXATION DEVICES TO COMPLETE THE ACL RECONSTRUCTION. ON (B)(6) 2018, THE PATIENT UNDERWENT HIS FIRST POST-OPERATIVE EVALUATION AND WAS FOUND TO HAVE COMPLETELY HEALED ARTHROSCOPY PORTALS, AS WELL AS PROXIMAL MEDIAL LEG INCISION AND WAS INSTRUCTED TO BEGIN A COURSE OF STRUCTURED PHYSICAL THERAPY. THE PATIENT UNDERWENT REGULAR PHYSICAL THERAPY TREATMENTS THROUGH (B)(6) 2018 DURING WHICH HE REPEATEDLY COMPLAINED OF SIGNIFICANT MEDIAL PATELLA PAIN AND OVERALL EXCRUCIATING PAIN AND DISCOMFORT. THE PATIENT CONTINUED TO FOLLOW UP WITH THE SURGEON BETWEEN FEBRUARY AND APRIL OF 2018 AND REPORTED ONGOING MEDIAL PROXIMAL TIBIA PAIN IN THE REGION OF THE TIBIAL TUNNEL SITE WHICH WAS NOTED TO HAVE ONGOING TENDERNESS TO PALPATION. ON (B)(6) 2018, THE PATIENT PRESENTED TO THE EMERGENCY ROOM FOR EVA

  Patient problems: Discomfort; Foreign Body In Patient; Pain

  MAUDE report 12121936 ↗
• InjuryNov 14, 2019Break; Detachment of Device or Device Component; Material Twisted/Bent; Migration

  IT WAS REPORTED VIA FDA MEDWATCH LETTER (MW5089877) THAT THE FOLLOWING INCIDENT OCCURRED: NITINOL GUIDE WIRE BROKE OFF, UNDETECTED BY MD/STAFF DURING ORIGINAL ACL REPAIR. THIS (SECOND) SURGERY WAS TO REMOVE BROKEN PIECE WHICH HAD SINCE MIGRATED. THE FACILITY HAS CONFIRMED THAT THE ORIGINAL ACL REPAIR SURGERY TOOK PLACE ON (B)(6) 2019. THE UNRETRIEVED FRAGMENT FROM THE(B)(6) 2019 PROCEDURE WAS DISCOVERED WHEN THE PATIENT HAD RETURNED TO THE MD'S OFFICE PRESENTING WITH KNEE PAIN AND AN X-RAY WAS OBTAINED. THE FACILITY DID NOT KNOW THE ACTUAL ARTHREX PART NUMBER OF THE GUIDEWIRE. THE FACILITY CONFIRMED THAT A SECOND SURGERY TOOK PLACE ON (B)(6) 2019 DURING WHICH THE PREVIOUSLY UNRETRIEVED GUIDE WIRE WAS LOCATED. THE SURGEON WAS NOT ABLE TO FULLY REMOVE THE UNRETRIEVED FRAGMENT FROM THE PATIENT. THE FACILITY HAD NO ADDITIONAL INFORMATION TO PROVIDE. THE SALES REP WHO WAS PRESENT DURING THE SECOND SURGERY REPORTED THAT THE SURGEON INDICATED THAT THE GUIDE PIN MIGHT HAVE GOTTEN BENT BEHIND THE SCREW AND BROKEN OFF. THE REP ALSO STATED THAT THE FACILITY HAS SINCE CHANGED THEIR PROCEDURES TO NOW MEASURE THE PIN AND INSPECT IT AFTER REMOVAL TO ENSURE THE ENTIRE GUIDE PIN IS TAKEN OUT. ALTHO

  Patient problems: Pain

  MAUDE report 9324377 ↗
• InjuryAug 14, 2018Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE 1.1MM GUIDEWIRE IN THE KIT BROKE DURING USE. CALLER WAS UNSURE ABOUT THE LOT, IT WAS EITHER F197765 OR F195689. THE GUIDE WIRE BROKE WHILE INSERTING THE TIBIAL SCREW (IT WAS A COMPETITOR SCREW); WIRE WAS RETRIEVED FROM THE PATIENT. IT WAS REPORTED BY THE SALES REP THAT THE FACILITY CONTACTED HIM REGARDING TWO EVENTS WHERE THE GUIDE WIRE FROM THE AR-1898S BROKE DURING USE. HE DID NOT KNOW THE BATCH NUMBERS, STATING THAT THE FACILITY GAVE HIM TWO POSSIBILITIES. HE DID NOT HAVE DATES OF SURGERIES, BELIEVES ONE WAS THIS WEEK (CASE 2495) AND ONE WAS LAST MONTH (CASE 2496). HE STATES THAT IN CASE 2496, THE GUIDE WIRE REMAINED IN THE PATIENT BUT WHEN THAT WAS REALIZED, THEY RE-OPENED THE PATIENT TO RETRIEVE THE WIRE. HE STATES THAT IN CASE 2495, IT WAS REMOVED PRIOR TO CLOSING THE PATIENT. ADDITIONAL INFORMATION OBTAINED 7/26/2018: RISK MANAGER HAS CONFIRMED THAT THIS EVENT (ARTHREX REFERENCE CASE 2495) TOOK PLACE ON (B)(6) 2018. PATIENT WAS A MALE WITH LEFT JOINT KNEE PAIN AND LEFT DISTAL FEMUR OSTEOCHONDRAL FRACTURE. PROCEDURE WAS COMPLICATED BY A 1.3 CM TIP OF A 13MM GUIDE PIN TIP THAT BROKE OFF INSIDE THE DISTAL FEMUR. IT WAS DETERMINED TO REMOVE IT WOULD HAVE

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7782017 ↗
• InjuryJul 31, 2018Break

  IT WAS REPORTED BY THE SALES REP THAT THE FACILITY CONTACTED HIM REGARDING TWO EVENTS WHERE THE GUIDE WIRE FROM THE AR-1898S BROKE DURING USE. HE DID NOT KNOW THE BATCH NUMBERS, STATING THAT THE FACILITY GAVE HIM TWO POSSIBILITIES. HE DID NOT HAVE DATES OF SURGERIES, BELIEVES ONE WAS THIS WEEK (CASE (B)(4)) AND ONE WAS LAST MONTH (CASE (B)(4)). HE STATES THAT IN CASE (B)(4), THE GUIDE WIRE REMAINED IN THE PATIENT BUT WHEN THAT WAS REALIZED, THEY RE-OPENED THE PATIENT TO RETRIEVE THE WIRE. HE STATES THAT IN CASE (B)(4), IT WAS REMOVED PRIOR TO CLOSING THE PATIENT. ADDITIONAL INFORMATION OBTAINED (B)(6) 2018: RISK MANAGER HAS CONFIRMED THAT THIS EVENT (ARTHREX REFERENCE CASE (B)(4)) TOOK PLACE ON (B)(6) 2018. PATIENT WAS IN PACU WHEN A POST OP X-RAY WAS TAKEN WHICH SHOWED THE RETAINED PIECE OF THE TIBIAL GUIDE PIN. PATIENT HAD EATEN POST OPERATIVELY AT THAT POINT, REQUIRING THEM TO WAIT AN ADDITIONAL 6 HOURS FOR SURGICAL REMOVAL. PATIENT WAS ADMITTED OVERNIGHT. PATIENT THEN UNDERWENT SUCCESSFUL REMOVAL OF THE GUIDE PIN TO PREVENT ANY COMPLICATIONS RELATED TO THE RETENTION OF THE GUIDE PIN.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7734484 ↗
• InjuryJul 9, 2018Detachment of Device or Device Component

  A (B)(6) Y/O FEMALE UNDERWENT LEFT KNEE ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION TO REPAIR LEFT ACL TEAR. ARTHREX TRANSTIBIAL GUIDE PIN UTILIZED DURING PROCEDURE. POST OP KNEE X-RAY COMPLETED WITH FINDING OF RETAINED PIECE OF THE TIBIAL GUIDE PIN. PT REQUIRED ADMISSION OVERNIGHT AS HAD EATEN POST OPERATIVELY AND NEED TO WAIT AN ADD'L 6 HRS PRIOR TO SURGICAL REMOVAL. PT UNDERWENT SUCCESSFUL REMOVAL OF GUIDE PIN ON (B)(6) 2018 TO PREVENT ANY COMPLICATIONS RELATED TO THE RETENTION OF GUIDE PIN.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7673490 ↗
• InjuryNov 30, 2017Break; Difficult to Remove

  IT WAS REPORTED VIA MEDWATCH (B)(4) THAT ON (B)(6) 2017 (LEFT KNEE ARTHROSCOPY PROCEDURE - ACL RECONSTRUCTION WITH AUTOGRAFT, POSSIBLE MENISECTOMY VS. REPAIR, LATERAL AND MEDIAL), A NITINOL WIRE FROM AND AR-1898S TRANSTIBIAL ACL DISPOSABLE KIT WAS POSITIONED FOR A SECOND ACL SCREW. TRIED TO PULL OUT THE NITINOL WIRE AND WAS NOT ABLE TO REMOVE. THE SURGEON USED A PAIR OF PLIERS ON THE WIRE AND USED A MALLET TO BANG OUT THE WIRE. THE WIRE THEN BROKE INSIDE THE FEMUR AND INSIDE PART OF THE SCREW. A MINI C-ARM WAS USED TO VERIFY THAT WIRE WAS IN THE JOINT. THE SURGEON CONFIRMED WIRE WAS NOT IN JOINT AND WIRE WAS NOT RETRIEVED. APPROXIMATELY A 2CM PIECE REMAINS IN THE PATIENT BONE. PATIENT WAS AN (B)(6) YEAR OLD FEMALE. FOLLOW-UP INVESTIGATION: THE REMAINDER OF THE NITINOL WIRE WAS DISPOSED OF AND IS NOT AVAILABLE TO RETURN FOR EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7070101 ↗
• InjuryMar 1, 2017Break; Detachment Of Device Component

  IT WAS REPORTED VIA A MEDWATCH (B)(4) THAT THE GUIDEWIRE/PIN BROKE DURING THE ATTEMPTED REMOVAL FROM THE INTERFERENCE SCREW AT THE 30 MM MARK. PATIENT (B)(6). ADDITIONAL INFORMATION OBTAINED 2/6/17: THE PROCEDURE WAS AN ACL RECONSTRUCTION. AN UN-RETRIEVED FRAGMENT APPROXIMATELY 30 MM REMAINED WITHIN THE SCREW IN THE FEMORAL TUNNEL INSIDE THE PATIENT. THE FRAGMENT WAS CONFIRMED VIA FLUOROSCOPY. THE PROCEDURE WAS COMPLETED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6367774 ↗