NA 254844Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886705027675), received between Feb 11, 2022 and Aug 12, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 12, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50221268 ↗
• MalfunctionSep 8, 2022Break; Break

  IT WAS REPORTED BY THE SALES REP IN AUSTRALIA THAT DURING AN ACL (ANTERIOR CRUCIATE LIGAMENT) RECONSTRUCTION PROCEDURE ON 8/22/2022, IT WAS OBSERVED THAT THE GUIDEWIRE 12" (STERILE 1 PACK) DEVICE BROKE. ACCORDING TO THE REPORT, AN X-RAY CONFIRMED THAT 5 CM OF THE GUIDEWIRE WAS LEFT IN THE PATIENT BUT WAS RETRIEVED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF 30 MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15380069 ↗
• MalfunctionMay 19, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2022, WHILE USING THE GUIDEWIRE 12 INCH STERILE DEVICE TO PUT THE DILATOR/SHEATH INSERTER/SCREW OVER, IT WAS OBSERVED THAT THE GUIDEWIRE DEVICE BENT WHEN MALLETING IN THE DILATOR. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14436344 ↗
• MalfunctionMay 19, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON AN UNKNOWN DATE IN (B)(6) 2021, WHILE USING THE GUIDEWIRE 12 INCH STERILE DEVICE TO PUT THE DILATOR/SHEATH INSERTER/SCREW OVER, IT WAS OBSERVED THAT THE GUIDEWIRE DEVICE BENT WHEN MALLETING IN THE DILATOR. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14436112 ↗
• MalfunctionMay 19, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER IN AUSTRALIA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON AN UNKNOWN DATE IN (B)(6) 2021, WHILE USING THE GUIDEWIRE 12 INCH STERILE DEVICE TO PUT THE DILATOR/SHEATH INSERTER/SCREW OVER, IT WAS OBSERVED THAT THE GUIDEWIRE DEVICE BENT WHEN MALLETING IN THE DILATOR. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14435974 ↗
• MalfunctionMay 19, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON AN UNKNOWN DATE IN (B)(6) 2021, WHILE USING THE GUIDEWIRE 12 INCH STERILE DEVICE TO PUT THE DILATOR/SHEATH INSERTER/SCREW OVER, IT WAS OBSERVED THAT THE GUIDEWIRE DEVICE BENT WHEN MALLETING IN THE DILATOR. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14435761 ↗
• MalfunctionApr 22, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE GUIDEWIRE 12 INCH STERILE DEVICE BECAME BENT WHEN MALLETING IN THE DILATOR. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14187173 ↗
• MalfunctionFeb 11, 2022Break; Break

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY, IT WAS OBSERVED THAT THE GUIDEWIRE 12 INCH STERILE DEVICE SNAPPED OFF INSIDE THE PATIENT'S KNEE WHILE INSERTING THE SCREW/SHEATH. ACCORDING TO THE REPORT, THE WIRE COULD NOT BE REMOVED ONCE THE SCREW WAS INSERTED, AND AS A RESULT OF PULLING ON THE WIRE, IT SNAPPED AND LEFT 3CM OF GUIDEWIRE INSIDE THE KNEE. THE REMAINING WIRE WAS ABLE TO BE REMOVED FROM ANOTHER PORTAL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A DELAY OF FIVE MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13515913 ↗