NA 232024Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20886705010964), received between Oct 5, 2023 and Jun 17, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Break” (4 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.

• MalfunctionJun 17, 2026Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC PROCEDURE THE RAPIDLOC MALLEABLE GRAFT RETRACT DEVICE THE GUIDE IS BROKEN INTO TWO. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25534928 ↗
• MalfunctionMay 4, 2026Break

  IT WAS REPORTED THAT DURING UNSPECIFIED ARTHROSCOPIC PROCEDURE THE RAPIDLOC MALLEABLE GRAFT RETRACT DEVICE BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25072020 ↗
• MalfunctionNov 17, 2025Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGERY, IT WAS OBSERVED THAT BEFORE SUTURING THE MENISCUS, THE RAPIDLOC MALLEABLE GRAFT RETRACT DEVICE WAS BENT TO FACILITATE THE ENTRY OF THE TRUESPAN AND IT BROKE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23567698 ↗
• MalfunctionNov 1, 2024Break; Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS DISCOVERED THAT THE RAPIDLOC MALLEABLE GRAFT RETRACT *PK/5 DEVICE WAS USED TO INITIATE THE MENISCAL SUTURE. THE DOCTOR FOLDED IT TO FACILITATE BETTER SUTURE ENTRY, BUT WHEN IT WAS STRAIGHTENED AGAIN, IT BROKE INTO TWO PIECES. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS AVAILABLE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20587859 ↗
• MalfunctionOct 5, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN SWITZERLAND THAT TWO MALLEABLE GRAFT RETRACTOR DEVICES DID NOT HAVE CE MARK. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17879012 ↗
• MalfunctionOct 5, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN SWITZERLAND THAT TWO MALLEABLE GRAFT RETRACTOR DEVICES DID NOT HAVE CE MARK. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17879002 ↗