Arthrex® AR-5035TB-09Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888867035461), received between Dec 7, 2016 and Oct 8, 2018 — classified as 6 injuries.

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. 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 8, 2018Break; Migration or Expulsion of Device

  THE ORIGINAL PART NUMBER AS SUBMITTED WAS INCORRECT PER AN UPDATE FROM THE CUSTOMER. THE NEW PART NUMBER IS AR-1351LB, BIO-TRANSFIX, LOT # 57088, UDI- (B)(4). THIS IS A FOLLOW-UP SUBMISSION DUE TO CHANGES TO THE PRODUCT PART NUMBER.

  Patient problems: Arthralgia; Device Embedded In Tissue or Plaque; Failure of Implant; Pain

  MAUDE report 7942934 ↗
• InjuryJul 24, 2018Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED, THAT ON (B)(6) 2016 AN AR-5035TB-09 BIO- INTERFERENCE SCREW WAS PLACED IN THE TIBIA AND 18 MONTHS THE SCREW IS REMOVED WITHOUT SIGNS OF BIODEGRADATION. ADDITIONAL INFORMATION OBTAINED 7/13/2018: THE PATIENT'S BONE QUALITY WAS REPORTED TO BE MEDIUM. THE ORIGINAL PROCEDURE TOOK PLACE ON (B)(6) 2016. DURING THE ORIGINAL SURGERY THE AR-5035TB-09 BIO-INTERFERENCE SCREW WAS IMPLANTED ALONG WITH ONE AC TIGHTROPE RT. NOTHING WAS IMPLANTED DURING THE SECOND SURGERY AS THE PROCEDURE WAS JUST TO REMOVE THE AR-5035TB-09 BIO-INTERFERENCE SCREW DUE TO PATIENT DISCOMFORT OF PLACEMENT OF THE SAME.

  Patient problems: Discomfort

  MAUDE report 7713368 ↗
• InjuryFeb 28, 2018Device Slipped; Failure to Align

  IT WAS REPORTED THAT POST-OP, THE AR-5035TB-09 SCREW WAS LOOSE AND MISALIGNED IN THE TIBIA. THE LOOSE SCREW WAS SUBCUTANEOUS PALPABLE. THE PATIENT ALSO COMPLAINED ABOUT DISCOMFORT. THE SURGEON DECIDED ON A REVISION SURGERY. THE INITIAL SURGERY ON (B)(6) 2015 WAS AN ACL ON THE LEFT KNEE JOINT.

  Patient problems: Discomfort

  MAUDE report 7302198 ↗
• InjuryOct 4, 2017Break

  IT WAS REPORTED THAT DURING SURGERY, THE TIP OF THE SCREW BROKE INSIDE THE DRILL HOLE. THE DEVICE COULD NOT BE RETRIEVED AND WILL REMAIN INSIDE THE PATIENT. NO FURTHER DETAILS GIVEN.

  Patient problems: Foreign Body In Patient

  MAUDE report 6913260 ↗
• InjuryDec 29, 2016Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION PROCEDURE, THE CANNULATED DELTA TAPERED BIO-INTERFERENCE SCREW, AR-5035TB-09, BROKE WHILE BEING SCREWED IN. AS SOON AS THE SURGEON STARTED TO INSERT THE SCREW THE SURGEON NOTICED THE SCREW SNAPPED. SURGEON MEASURED THE PART OF SCREW INSIDE THE WOUND AS 14MM. SURGEON DECIDED TO TAKE OUT THE 21MM PART. SURGEON THEN TESTED THE GRAFT TO CHECK ITS STABILITY AND FOUND IT JUST ABOUT ACCEPTABLE. SURGEON CONTINUED TO FINISH THE OPERATION. 14MM OF THE BROKEN SCREW WAS LEFT INSIDE OF THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 6212718 ↗
• InjuryDec 7, 2016Split

  IT WAS REPORTED THAT AN ACL WAS PERFORMED ON (B)(6) 2016 WITH A 5X50 ARTHREX BIODEGRADABLE AND ARTHREX BIODEGRADABLE INTERFERENCE SCREW. THE PATIENT STARTED WITH PAIN AND THE SURGEON INTERVENED ON (B)(6) 2016 FOR A REVISION WHERE WE FOUND THE BIODEGRADABLE INTERFERENCE SCREW SPLIT IN TWO PARTS. ONE ARTHROSCOPY AND ONE OPEN PART WAS REMOVED AND A NEW INTERFERENCE WAS PLACED, THIS TIME TITANIUM (10X30 ARTHREX). PATIENT: (B)(6) MALE. PATIENT IS STABLE AND DOING FINE.

  Patient problems: Pain

  MAUDE report 6150569 ↗