Arthrex® AR-1897SRecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888867022454), received between Mar 10, 2017 and Sep 14, 2023 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2023Component Missing; Component Missing

  ON 8/18/2023, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA SEMS THAT AN AR-1897S TRANSTIBIAL ACL DISPOSABLES KIT HAD 2 OF 5 GUIDE PINS THAT DID NOT COME WITH THE BEATH PIN IN THEM. THIS WAS DISCOVERED UPON OPENING THE PACKAGE DURING A PROCEDURE, WITH NO REPORTED ADVERSE EVENT OR PATIENT HARM. ADDITIONAL INFORMATION REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17746312 ↗
• InjuryApr 11, 2022Break; Device Damaged by Another Device

  ON 3/24/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-1897S TRANSTIBIAL ACL DISPOSABLES KIT HAD A NITINOL WIRE THAT BROKE INSIDE THE PATIENT. AFTER SURGEON INSERTER THE NITINOL WIRE IN THE FEMORAL TUNNEL, A SCREW WAS PLACED IN. HOWEVER, WHILE SURGEON WAS SCREWING IN THE SCREW THE BACK WALL OF THE FEMUR BLEW OUT AND IT CAUSED JUST ABOUT 1MM OF THE NITINOL WIRE TO SNAP. SURGEON MADE AN INCISION IN THE BACK OF THE KNEE IN AN ATTEMPT TO GET ACCESS TO THE NITINOL WIRE BUT COULD NOT. CASE WAS COMPLETED USING A TIGHTROPE AND ADDITIONAL SCREW FROM ANOTHER MANUFACTURER. THERE WAS A DELAY IN THE SURGERY OF ROUGHLY ONE HOUR AND A HALF. SALES REPRESENTATIVE COULD NOT CONFIRM IF ADDITIONAL ANESTHESIA WAS ADMINISTER DUE TO DELAY IN SURGERY. THE LOT NUMBER FOR AR-1897S TRANSTIBIAL ACL DISPOSABLES KIT IS UNKNOWN AS WELL. THIS WAS DISCOVERED DURING A QUAD ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 14075205 ↗
• InjuryFeb 26, 2020Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER AN ACL CASE, AN X-RAY SHOWED THAT ABOUT 3 INCHES OF THE GUIDEWIRE IN THE AR-1897S KIT REMAINED IN THE PATIENT. SAME DAY, THEY WENT BACK INTO THE PATIENT AND REMOVED IT. PATIENT IS MALE, (B)(6); HE DID NOT REQUIRE ANY ADDITIONAL HOSPITALIZATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 9756018 ↗
• InjuryJun 26, 2019Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2019 WHERE THE FOLLOWING DEVICES WERE IMPLANTED: AR-1588RT-J, LOT: 10259067; AR-1897S, LOT: 10224925; AR-4030C-10, LOT: 10198681; AR-7209T, LOT: 12863; JRF SPEEDGRAFT ID: 183528-015 (NOT AN ARTHREX PRODUCT). IT WAS REPORTED THAT THE PATIENT UNDERWENT AN ACL RECONSTRUCTION PROCEDURE ON (B)(6) 2019 WHERE THE FOLLOWING DEVICES WERE IMPLANTED: AR-1588RT-J, LOT: 10259067; AR-1897S, LOT: 10224925; AR-4030C-10, LOT: 10198681; AR-7209T, LOT: 12863; JRF SPEEDGRAFT ID: 183528-015 (NOT AN ARTHREX PRODUCT). THIS CASE WAS COMPLETED WITH NO ISSUE. THE PATIENT WAS SEEN FOR HIS FIRST POST-OP VISIT ON (B)(6) 2019 AND PER THE PA: ¿SKIN INTACT; PORT AND GRAFT INCISIONS CLEAN, DRY AND INTACT WITH SUTURES. NO ERYTHEMA OR SIGNS OF INFECTION. MILD REDNESS SECONDARY TO SUTURE REACTION.¿ THE PATIENT WAS SEEN FOR A 2ND FOLLOW-UP VISIT AND THE SURGEON REPORTED: ¿35ML OF SEROSANGUINOUS FLUID ASPIRATED FROM THE RIGHT KNEE AFTER ALCOHOL PREP, NO HINT OF TURBCLITY.¿ THIS WAS DONE IN RESPONSE TO INCREASED DWELLING AND DISABILITY FOR THREE DAYS. SURGEON REPORTS: ¿NOT CLINICALLY A DVT; INFECTION A CONCERN, BUT ALSO, CLINICALLY, DOE

  Patient problems: Edema; Limited Mobility Of The Implanted Joint; Pain; Purulent Discharge; Unspecified Infection

  MAUDE report 8734888 ↗
• InjuryMay 2, 2019Break; Detachment of Device or Device Component

  IT WAS REPORTED VIA FDA MEDWATCH LETTER (MW5084931) THAT A PIECE OF THE NITINOL GUIDEWIRE (FROM THE TRANS-TIBIAL ACL DISPOSABLE KIT) BROKE OFF. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE FACILITY MEDWATCH REPORTER BUT AT THIS TIME NO FURTHER INFORMATION WAS RECEIVED.

  Patient problems: No Code Available

  MAUDE report 8574272 ↗
• InjuryOct 27, 2017Break; Detachment Of Device Component

  IT WAS REPORTED VIA MEDWATCH ((B)(4)): DURING A LEFT KNEE TRANS-ARTHROSPORIC ANTERIOR CRUCIATE LIGAMENT ALLOGRAFT, PRIOR PATELLAR TENDON BTB GRAFT FROM THE PATIENT AUTOGRAFT AS WELL AS A PARTIAL MEDIAL MENISCECTOMY, 2CM OF THE GUIDE WIRE TIP BROKE OFF IN THE 7MM CANNULATED SILK SCREW. SURGEON MADE DECISION TO LEAVE BROKEN TIP IN PATIENT. FOLLOW-UP INVESTIGATION: X-RAYS WERE TAKEN POST-OP TO CONFIRM THE LOCATION OF THE BROKEN TIP.

  Patient problems: Foreign Body In Patient

  MAUDE report 6983482 ↗
• InjuryMar 10, 2017Fracture; Migration or Expulsion of Device

  IT WAS REPORTED BY THE FACILITY VIA THEIR MEDWATCH REPORT (B)(4) THAT: "PATIENT HAD ACL REPAIR DONE (B)(6) 2015. DURING THE PROCEDURE, A GUIDEWIRE WAS PLACED INTO THE FEMUR AND THE SCREW THREADED OVER THE WIRE. ONCE THE SCREW WAS IN PLACE, THE GUIDE WIRE WAS REMOVED. IT WAS DISCOVERED DURING OUTPATIENT FOLLOW-UP WITH SUBSEQUENT FILMS THAT A FRAGMENT OF THE GUIDEWIRE, 2 MM IN LENGTH, WAS IDENTIFIED. A CLINICAL DECISION WAS MADE TO LEAVE THE FRAGMENT IN PLACE (RISK VS. BENEFIT). AT THE TIME OF THE SURGERY, THERE WAS NOTHING TO SUGGEST AN ISSUE. LATER WHEN THE FRAGMENT MIGRATED OUT, THE PATIENT MADE THE DECISION TO SEE ANOTHER PHYSICIAN AND THE DECISION WAS MADE AT THAT TIME TO HAVE THE WIRE REMOVED. THE PATIENT HAD SURGERY ON (B)(6) 2016 TO HAVE THE GUIDEWIRE REMOVED. IT HAD MIGRATED OUT OF THE BONE POSTERIORLY. THE CONSENT WAS WORDED THAT THE PATIENT WOULD BE HAVING REMOVAL OF PAINFUL HARDWARE. THERE WAS NO DOCUMENTATION TO SUGGEST THE ITEM WAS THE FRACTURED GUIDEWIRE THAT WOULD BE SENT TO PATHOLOGY. THE REMOVED PIECE WAS GIVEN TO THE PATIENT POST OPERATIVELY.

  Patient problems: Foreign Body In Patient

  MAUDE report 6394921 ↗