BIOSURE 72201201Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03596010587671), received between Apr 3, 2019 and Mar 13, 2024 — classified as 4 injuries, 2 malfunctions.

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

• MalfunctionMar 13, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT DURING SET UP FOR AN ACL RECONSTRUCTION SURGERY, IT WAS NOTICED THAT THE PACKAGING OF THE GUIDE WIRE 1.2 MM HAD A CUT, COMPROMISING THE STERILITY OF THE IMPLANT. THERE WAS A S+N BACK UP DEVICE AVAILABLE. THERE WAS NO DELAY REPORTED AND THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18898984 ↗
• InjuryJun 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 3 WEEKS AFTER AN ARTHROSCOPY AND ARTHROLYSIS OF THE LEFT HIP, THE PATIENT COMPLAINED OF PAIN. A SOFT GUIDE WIRE TIP WAS FOUND, THE TIP OF WHICH WAS VISIBLE UNDER THE SKIN AND DETECTABLE ON CLINICAL EXAMINATION DURING THE CONSULTATION. IT WAS DECIDED TO REMOVE THIS PIECE OF GUIDE WIRE, APPROXIMATELY 3 CM LONG, PERCUTANEOUSLY AND UNDER LOCAL ANESTHESIA. DURING THE FIRST OPERATION, A RADIOLOGICAL CHECK WAS CARRIED OUT IN THE OPERATING ROOM USING AN IMAGE INTENSIFIER. THIS PIECE OF WIRE WAS NOT IDENTIFIED. PATIENT CURRENT STATUS IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 14671991 ↗
• InjuryMar 22, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ACL ARTHROSCOPIC PROCEDURE, AFTER FEMORAL AND TIBIAL MEASUREMENTS WERE TAKEN, THE SURGEON ASKED FOR THE 1.2MM NITINOL GUIDE TO FIX THE GRAFT TO THE FEMORAL TUNNEL USING A 'BIOSURE REGENESORB' ANCHOR. AFTER THE SURGEON PASSED THE GRAFT, AT THE MOMENT THE SURGEON PROCEEDED TO PASS THE SCREW, IT WAS OBSERVED THE TIP OF THE GUIDEWIRE HAD BROKEN. AS RESULT, THE COMPLETE GUIDEWIRE WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT SURGICAL DELAY USING A S+N BACKUP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13847450 ↗
• InjuryDec 15, 2021Break; Break

  IT WAS REPORTED THAT DURING USE IN A LEFT KNEE ARTHROSCOPICALLY ASSISTED ACL RECONSTRUCTION WITH BON-PATELLAR TENDON-BONE AUTOGRAFT AND A POSTEREOLATERAL CORNER RECONSTRUCTION WITH ALLOGRAFT, DURING PLACEMENT ON THE FEMORAL SIDE WITH A METAL INTERFERENCE SCREW, THE GUIDE WIRE BROKE OFF, THE GUIDE WIRE WAS LEFT IN PLACE, AS REMOVING IT WOULD HAVE CAUSED HARM TO THE PATIENT. THE KNEE WAS BROUGHT INTO EXTENSION AND SHOWED NO IMPINGEMENT FROM THE GUIDE WIRE. IT IS UNKNOWN IF THERE WAS A DELAY OR IF A BACKUP DEVICE WAS AVAILABLE AND HOW THE ISSUE WAS RESOLVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13009924 ↗
• InjuryNov 4, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING RIGHT ACL PROCEDURE, THE GUIDE WIRE BROKE OFF AT THE TIP WHILE TRYING TO INSERT SOFTSILK SCREW IN FEMUR. TIP WAS RETRIEVED FROM KNEE AND WAS CONFIRMED VIA X-RAY THAT NO REMAINING PART WERE IN PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10787996 ↗
• MalfunctionApr 3, 2019Break

  IT WAS REPORTED THAT DURING A HIP ARTHROSCOPY WHEN WIRE WAS PASSED INTO PATIENT, THE TIP BROKE. THE BROKEN PIECE WAS LATER RETRIEVED FROM PATIENT. THERE WAS NO SIGNIFICANT DELAY OR PATIENT INJURIES REPORTED BUT IT IS UNKNOWN IF A BACKUP WAS AVAILABLE TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8480655 ↗