ACUFEX TRUNAV 72204037Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00885554037661), received between May 19, 2021 and Oct 10, 2023 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionOct 10, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE RETROGRADE DRILL TIP WAS STUCK INSIDE THE TUNNEL WHEN THE TIBIAL TUNNEL WAS FINISHED. THE DRILL TIP BROKE AND IT WAS COMPLETELY REMOVED WITH SUTURE FORCEPS. THE PROCEDURE WAS COMPLETED WITHOUT SURGICAL DELAY USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17908689 ↗
• InjuryFeb 20, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, THE WIRE OF THE RETROGRADE DRILL BLADE WAS BROKEN AFTER THE BONE HOLE WAS MADE USING THE DRILL. ALL THE BROKEN PARTS WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16405440 ↗
• InjuryAug 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON LITERATURE REVIEW CLINICAL OUTCOMES OF THE ACUFEX TRUNAV RETROCUTTER DRILL FOR TUNNEL CREATION FOR ACL RECONSTRUCTION, AFTER AN ACL RECONSTRUCTION PROCEDURE, WHERE A TRUNAV DRILL WAS USED TO CREATE THE FITTED BONE TUNNELS, 4 PATIENTS REQUIRED A REVISION SURGERY FOR A MENISCAL DEBRIDEMENT AND 1 OTHER PATIENT REQUIRED A REVISION SURGERY FOR A MENISCAL REPAIR. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15241853 ↗
• InjuryDec 20, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY PROCEDURE, WHEN USING THE ACUFEX TRUNAV RETROGRADE DRILL TO SUTURE THE MENISCUS ROOT, THE DRILL BROKE, IT WAS REMOVED WITH A CLAMP. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13042792 ↗
• InjuryAug 24, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN ARTHROSCOPY PROCEDURE, THE BLADE OF THE RETROGRADE DRL 5.5MM COULD NOT BE DEPLOYED AND THE WIRE BROKE AFTER INSERTING THE DRILL INTO THE JOINT. ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12362840 ↗
• InjuryMay 19, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY, THE RETROGRADE DRL UNDER THE LASER MARK WAS BROKEN AFTER MAKING A BONE HOLE AND BEFORE OVER DRILLING. ALL BROKEN PIECES WERE REMOVED FROM THE PATIENT. 15 MINUTES DELAY, NO PATIENT COMPLICATIONS WERE REPORTED. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11848014 ↗