BIOSURE 72201887Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 03596010615398), received between Oct 26, 2018 and Feb 19, 2024 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2024Flaked; Flaked

  IT WAS REPORTED THAT DURING SET UP, SEVEN BIOSURE DRIVERS HAD METAL FRAGMENTS. IT IS UNKNOWN, IF THERE WAS A BACK UP DEVICE AVAILABLE. NO SURGICAL DELAY WAS REPORTED AND NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18733069 ↗
• MalfunctionFeb 19, 2024Flaked; Flaked

  IT WAS REPORTED THAT DURING SET UP, SEVEN BIOSURE DRIVERS HAD METAL FRAGMENTS. IT IS UNKNOWN, IF THERE WAS A BACK UP DEVICE AVAILABLE. NO SURGICAL DELAY WAS REPORTED AND NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18732611 ↗
• MalfunctionFeb 5, 2024Break; Break

  IT WAS REPORTED THAT DURING SET UP, THE TIP OF THE BIOSURE DRIVER WAS FRACTURED. THERE WAS A SMITH AND NEPHEW BACK UP DEVICE AVAILABLE AND NO SURGICAL DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18641306 ↗
• MalfunctionNov 16, 2023Crack; Material Deformation; Naturally Worn; Crack; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE BIOSURE SCREW WAS DAMAGED DURING THE IMPLANTATION USING THE SCREW DRIVER. THE PROCEDURE WAS COMPLETED WITH A CHANGE IN THE SURGICAL TECHNIQUE. THERE WAS A NON-SIGNIFICANT SURGICAL DELAY AND NO FURTHER COMPLICATIONS WERE REPORTED. RESULTS OF INVESTIGATION FOUND THE DISTAL TIP OF THE DEVICE IS BADLY FLARED AND HAS SOME CRACKS IN THE METAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18150073 ↗
• MalfunctionMay 29, 2023Break; Break

  IT WAS REPORTED THAT DURING A KNEE PROCEDURE, THE BIOSURE DRIVER SNAPPED WHEN INSERTING INTO THE TIBIA. ALL THE BROKEN PIECES WERE RETRIEVED USING GRASPERS. THE PROCEDURE WAS COMPLETED WITH NON-SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. CURRENT PATIENT STATUS IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17017186 ↗
• MalfunctionJul 15, 2021Corroded; Corroded

  IT WAS REPORTED THAT TWO BIOSURE SCREWS HAD RUST INSIDE OF IT. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12171083 ↗
• MalfunctionDec 20, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING A CROSS BAND THE SCREWDRIVER WAS BENT. IT IS UNKNOWN HOW WAS THE PROCEDURE COMPLETED SINCE IT WAS REPORTED THAT NO BACK-UP DEVICE WAS AVAILABLE. NO PATIENT INJURY, DELAY 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 9500911 ↗
• MalfunctionApr 15, 2019Difficult to Insert; Material Deformation

  IT WAS REPORTED THAT DURING SURGERY, THE DEVICE ON THE LOAN SET WAS DAMAGED AND NOT ABLE TO INSERT A 1.2 GUIDE WIRE DOWN THE CANNULATED SHAFT. IT SEEMS LIKE THE HEAD OF THE DRIVER WAS DISTORTED OR TOO TIGHT TO FIT ANY WIRE THROUGH. THERE WAS NO BACKUP DEVICE AVAILABLE AND IT IS UNKNOWN HOW THE ISSUE WAS SOLVED. NO DELAY NOR PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8514513 ↗
• MalfunctionApr 15, 2019Fitting Problem

  IT WAS REPORTED THAT DURING THE PROCEDURE, 1.2MM GUIDEWIRE NOT FITTING DOWN THE END OF THE DEVICE. NO BACKUP DEVICE WAS AVAILABLE AND NO PATIENT INJURIES WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8513662 ↗
• MalfunctionOct 26, 2018Thermal Decomposition of Device

  IT WAS REPORTED THAT THE NOSE OF THE DRIVER WAS FLARED. THERE WAS NO SIGNIFICANT DELAY OR PATIENT INJURIES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8009944 ↗