ACUFEX 012036Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03596010023728), received between Jul 12, 2019 and Jun 27, 2022 — classified as 2 injuries, 3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 27, 2022Break; Break

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY PROCEDURE USING PUNCH SCISSOR STRAIGHT, WHEN THE SPECIALIST WAS CUTTING THE TENDON, THE FORCEPS BROKE OFF. THE BROKEN PIECES WERE REMOVED FROM THE PATIENT WITH GRASPER FORCEPS. THE SURGERY DID NOT DEPEND ON THE INSTRUMENT TO BE COMPLETED. NO SURGICAL DELAY NOR FURTHER COMPLICATIONS WERE REPORTED. THE PATIENT'S HEALTH CONDITION IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14830469 ↗
• InjuryApr 12, 2022Break; Break

  IT WAS REPORTED THAT, DURING A KNEE ARTHROSCOPY, THE FIXED PART OF A PUNCH SCISSOR STRAIGHT LOOP HANDLE BROKE OFF WHILE IN USE INSIDE THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. THE PATIENT HAD TO UNDERGO A SECOND SURGERY TO HAVE THE ITEM THAT BROKE OFF REMOVED. CURRENT HEALTH STATUS OF THE PATIENT IS STABLE.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14080302 ↗
• MalfunctionMar 14, 2022Break; Break

  IT WAS REPORTED THAT, DURING A SHOULDER ARTHROSCOPY, WHEN THE 'PUNCH SCISSOR' WAS OPENED, IT WAS NOTICED THAT THE JAW WAS BROKEN. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13764245 ↗
• MalfunctionJan 15, 2021Break

  IT WAS REPORTED THAT THE PUNCH SCSR STR WERE BITING AT EDGES. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11175953 ↗
• MalfunctionJul 12, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT, DURING A BICEPS TENODESIS SURGERY, THE SCISSOR PUNCH CLAMP BROKE INSIDE OF THE PATIENT. ALL FRAGMENTS WERE RETRIEVED FROM THE PATIENT BY USING A GRASPER. A BACK-UP DEVICE WAS USED TO COMPLETE THE PROCEDURE WITHIN THE SCHEDULED TIME. THE PATIENT WAS NOT INJURED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8786958 ↗