BIOSURE 7211138Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 03596010559050), received between Aug 27, 2018 and Jun 1, 2026 — classified as 10 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 1, 2026Break

  IT WAS REPORTED THAT, DURING A SURGERY, THE GUIDE WIRE BROKE DURING USE. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF LESS THAN 30 MINUTES USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25356508 ↗
• InjuryFeb 19, 2025Break; Break

  IT WAS REPORTED THAT, DURING A PROCEDURE, THE GUIDE WIRE SNAPPED ON ATTEMPTED RETRACTION. ON IMAGING RETAINED, THE GUIDEWIRE WAS SEEN INTRAOSSEOUSLY, THEREFORE, IT WAS DECIDED IT WOULD NOT IMPACT THE PATIENT AND WOULD CAUSE GREATER HARM TO ATTEMPT TO REMOVE IT. IT IS UNKNOWN IF A BACK-UP DEVICE WAS NEEDED OR IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21413358 ↗
• MalfunctionNov 20, 2024Flaked; Flaked

  IT WAS REPORTED THAT, DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY, WHEN USING THE GUIDE WIRE, SMALL PIECES OF METAL WERE SEEN INSIDE THE PATIENT'S JOINT. SURGERY WAS COMPLETED WITH A SMITH AND NEPHEW BACK-UP DEVICE INSTEAD. THERE WAS A DELAY OF LESS THAN 30 MINUTES, AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20736199 ↗
• InjurySep 23, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, WHEN INSERTING THE GUIDE WIRE INTO THE BIOSURE SCREW, THE TIP OF THE GUIDE WIRE WAS BROKEN. THE BROKEN PIECE WAS LEFT IN THE BODY AND COULD NOT BE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20279899 ↗
• MalfunctionMar 21, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, WHILE OPENING THE GUIDE WIRE 1.2MM, THERE WAS A DEFECT BECAUSE THE WIRE BROKE WHEN THE SURGEON WAS TRYING TO INTRODUCE THE WIRE INTO THE TIBIAL TUNNEL, HENCE, A NEW GUIDE WIRE 1.2MM WAS OPENED AND USED AND THE BROKEN PIECE WAS REMOVED FROM THE PATIENT. THERE WAS A SURGICAL DELAY OF LESS THAN 30 MINUTES AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 18952036 ↗
• InjuryMar 19, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING A LIGAMENT ARTHROSCOPY, THE GUIDE WIRE BROKE OFF IN THE LIGAMENTOPLASTY SCREW. THE PIECE WERE NOT RETRIEVED FROM THE PATIENT. THERE WAS SMITH AND NEPHEW BACK UP DEVICE AVAILABLE AND THERE WAS A ONE (1) HOUR DELAY REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18935403 ↗
• MalfunctionAug 17, 2023Break; Break

  IT WAS REPORTED THAT DURING A KNEE LIGAMENTOPLASTY, THE GUIDE WR BROKE. THE PROCEDURE WAS COMPLETED WITH A S+N BACK UP DEVICE. THERE WAS NO SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17569467 ↗
• MalfunctionAug 8, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE DISTAL TIP OF THE GUIDE WIRE WAS BROKEN WHEN THE BIOSURE WAS INSERTING INTO THE BONE HOLE. THE BROKEN PIECE WAS REMOVED FROM THE BODY. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED, AND A NON-SIGNIFICANT SURGICAL DELAY WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17482303 ↗
• InjuryMay 18, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE GUIDE WIRE USED TO GUIDE THE LIGAMENT BROKE IN THE POSTERIOR KNEE BEHIND THE LATERAL FEMORAL CONDYLE, LEAVING AROUND 3.5 CM OF WIRE IN THE BONE. THE DEVICE REMAINED INSIDE THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED AND OR IF THERE WAS A DELAY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 16955270 ↗
• InjuryJul 12, 2022Break; Difficult to Insert; Break; Difficult to Insert

  IT WAS REPORTED THAT, DURING AN ACL PROCEDURE, THE GUIDEWIRE WAS PLACED FOR BIOSURE REGENESORB SCREW THROUGH THE HAMSTRING AUTOGRAFT, AS OPPOSED TO ADJACENT TO THE GRAFT. THIS CAUSED THE GUIDEWIRE TO GET STUCK IN THE ACL TIBIAL TUNNEL, AND IT PRESENTED IN THE JOINT SPACE. AN ATTEMPT TO REMOVE IT WITH AN ARTERY WAS MADE, BUT THIS BENT THE GUIDEWIRE. THEN, A WIRE DRIVER WAS USED TO TRY TO BACK THE GUIDEWIRE OUT, WHICH CAUSED THE WIRE TO SNAP. IT WAS NECESSARY TO SNAP THE PROXIMAL PART OF THE WIRE THROUGH THE MEDIAL PORTAL, THUS LEAVING A SECTION OF IT IN THE PATIENTS TIBIAL TUNNEL. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT DELAY BUT IT IS UNKNOWN HOW. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 14991353 ↗
• InjuryOct 5, 2021Break; Break

  IT WAS REPORTED THAT WHEN THEY INSERTED THE BIOSURE PK SCREW DURING AN ACL OVER THE GUIDEWIRE, THE GUIDEWIRE COULD THEN NOT BE REMOVED AS IT HAD BENT. IT THEN SNAPPED OFF IN THE TUNNEL. THIS END COULD NOT BE REMOVED AND WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A S+N BACK-UP DEVICE. A SIGNIFICANT DELAY WAS REPORTED, AND NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 12580166 ↗
• InjuryOct 4, 2021Break; Break

  IT WAS REPORTED THAT DURING ACL PROCEDURE, INTERNAL TO PATIENT, A WIRE FRAGMENT OF THE GUIDE WR 1.2MM X 12 BOX OF 5 STERILE WAS DISPLACED AND MAY HAVE BEEN INSIDE THE ABSORBABLE INTERFERENCE SCREW. THE PROCEDURE COULD NOT BE SUCCESSFULLY COMPLETED SINCE THE WIRE FRAGMENT WAS STILL INSIDE THE PATIENT AND MAY NEED AN ADDITIONAL SURGERY TO REMOVE IT. CURRENT PATIENT STATUS AND HOW THE ISSUE WAS RESOLVED IS UNKNOWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 12572720 ↗
• MalfunctionAug 24, 2020Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT, DURING AN ANTERIOR CRUCIATE LIGAMENT SURGERY, WHEN THE PACKAGE WAS OPENED, IT WAS NOTICED THE STERILE PACKAGE OF THE "1.2MM X 30CM GUIDE WIRE" WAS NOT SEALED PROPERLY. ALTHOUGH THE SURGERY WAS NOT DELAYED, IT IS UNKNOWN IF A BACK-UP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO PATIENT INJURIES OR 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 Known Impact Or Consequence To Patient

  MAUDE report 10442950 ↗
• InjuryAug 19, 2020Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION SURGERY, THE GUIDE TIP BROKE IN TWO DURING THE INSERTION OF THE BIOSURE REGENESORB SCREW. BOTH PIECES WERE SUCCESSFULLY RETRIEVED USING TWEEZERS. THERE WAS A DELAY OF UNDER 30 MIN AND THE PROCEDURE WAS COMPLETED USING A S+N BACKUP DEVICE. NO FURTHER 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 10424714 ↗
• InjuryJul 30, 2020Break; Break

  IT WAS REPORTED THAT DURING A REVISION SURGERY PERFORMED ON (B)(6) 2020 THE 7CM LONG NITINOL GUIDE WIRE BROKE OFF DURING THE INSERTION OF TIBIA SCREW, ALSO THE GUIDE WIRE WAS FOUND BROKEN IN THE KNEE JOINT. AN X-RAY WAS PERFORMED ON (B)(6) 2020 AND CONFIRMED THE BROKEN WIRE IN THE KNEE JOINT. IT WAS REPORTED THAT A SURGERY WAS PERFORMED ON (B)(6) IN ORDER TO REMOVE THE BROKEN DEVICE.

  Patient problems: Injury

  MAUDE report 10343653 ↗
• MalfunctionNov 2, 2018Break

  IT WAS REPORTED THAT WHEN SCREW FIXATION TO FEMORAL, THE WIRE BROKE INSIDE THE PATIENT. THE BROKEN PIECE WAS REMOVED. NO PATIENT INJURY WAS REPORTED, BUT THE PROCEDURE WAS EXTENDED 2 HOURS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8033539 ↗
• InjuryAug 27, 2018Break; Physical Resistance/Sticking

  IT WAS REPORTED THAT AFTER SURGERY, X-RAYS WERE PERFORMED AND IT WAS FOUND THAT A BROKEN TIP OF GUIDEWIRE REMAINED IN THE PATIENT, SO THE PATIENT WAS TAKEN BACK TO SURGERY ON THE SAME DAY TO REMOVE THE BROKEN PIECE. NO FURTHER INFORMATION IS AVAILABLE ABOUT THE PATIENT AND THE OUTCOME OF THE SURGERY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7820769 ↗