NA 013554Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 03596010091093), received between Jan 9, 2018 and Apr 28, 2026 — classified as 3 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Break

  IT WAS REPORTED THAT, DURING AN ACL PROCEDURE, THE SURGEON ATTEMPTED TO OPEN THE OPEN AREA, STATING THAT IT WAS TOO TIGHT AND HE WAS GOING TO CUT THE GRAFT, AND THEN A SLOTTED TENDON STRIPPER'S TIP BROKE. THE PROCEDURE WAS RESUMED, USING THE SAME DEVICE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25020746 ↗
• InjuryJul 31, 2024Break; Break

  IT WAS REPORTED THAT DURING AN ACL LIGAMENTOPLASTY, THE TENDON STRIPPER SLOTTED END BROKE WHEN THE TENDON WAS REMOVED, AND IT WAS LEFT IN THE PATIENT BECAUSE IT COULD NOT BE FOUND. THE PROCEDURE WAS COMPLETED USING THE SAME REPORTED DEVICE IT IS UNKNOWN IF THERE WAS A DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19878714 ↗
• MalfunctionJul 21, 2023Break; Break

  IT WAS REPORTED THAT DURING AN ACL, A TENDON STRIPPER SLOTTED WAS BROKEN. SURGERY CONTINUED WITHOUT ANY DELAY WITH A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17375329 ↗
• MalfunctionMay 3, 2023Break; Break

  IT WAS REPORTED THAT DURING A PATELLAR REALIGNMENT PROCEDURE, THE TENDON STRIPER DEVICE BROKE WHEN THE DOCTOR TRIED TO REMOVE THE TENDON. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY USING A BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16863358 ↗
• MalfunctionMar 21, 2023Break; Break

  IT WAS REPORTED THAT DURING SET UP FOR AN ARTHROSCOPY, THE TIP OF THE TENDON STRIPPER SLOTTED WAS FOUND BROKEN AT THE EXIT OF THE STERILIZATION TRAY. A PART OF THE TIP IS MISSING. A SECOND TENDON STRIPPER FROM ANOTHER TRAY WAS USE TO COMPLETE THE PROCEDURE. NO DELAY WAS REPORTED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16588014 ↗
• MalfunctionSep 24, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ACL HAMSTRING REPAIR, OUTSIDE THE PATIENT, THE SURGEON COULD NOT FIT THE HAMSTRING TENDON INTO THE SLOTTED TENDON STRIPPER AS THE SLOT WAS NOT BIG ENOUGH. THE SURGEON TRIED TO MAKE THE SLOT AT THE DISTAL TIP BIGGER USING ANOTHER INSTRUMENT TO TRY AND WIDEN THE SLOT, THIS LED TO THE DISTAL TIP BREAKING. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NON-SIGNIFICANT SURGICAL DELAY USING A S+N BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15476755 ↗
• MalfunctionAug 23, 2022Break; Break

  IT WAS REPORTED THAT DURING AN ACL SURGERY, AT THE TIME OF THE EXTRACTION THE TENDON OUTSIDE OF THE PATIENT'S KNEE, THE TENDON STRIPPER BROKE, BUT THE LARGE ONE WAS USED TO EXTRACT AND SUCCESSFULLY COMPLETE THE SURGERY WITHOUT DELAY. THE PATIENT'S HEALTH CONDITION IS STABLE AND NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15280389 ↗
• InjuryJun 29, 2022Break; Break

  IT WAS REPORTED THAT, DURING AN ACL RECONSTRUCTION, THE TIP OF THE TENDON STRIPPER BROKE OFF INSIDE THE PATIENT'S THIGH WHEN THE SURGEON WAS TRYING TO HARVEST THE GRAFT. THE BROKEN PIECES WERE RETRIEVED FROM THE PATIENT USING TWEEZERS. THE PROCEDURE WAS COMPLETED WITH A NON-SIGNIFICANT DELAY USING A SMITH AND NEPHEW BACK-UP DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED. PATIENT STATUS IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14860129 ↗
• InjuryNov 30, 2021Break; Break

  IT WAS REPORTED THAT, DURING AN ACL, THE SURGEON TRIED TO OPEN THE FLOW OF THE TENDON STRIPPER SLOTTED MORE WHICH LED A BREAKAGE INSIDE THE PATIENT. ALL THE PIECES OF THE BROKEN DEVICE WERE REMOVED. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A COMPETITORS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12897769 ↗
• MalfunctionMay 14, 2021Break; Break

  IT WAS REPORTED THAT THE TENDON STRIPPER SLOTTED BROKE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11826965 ↗
• MalfunctionJan 7, 2021Break; Break

  IT WAS REPORTED THAT DURING AN ARTHROSCOPY THE TENDON STRIPPER WAS BENT BEFORE THE PROCEDURE, SO THE CUSTOMER EXERTED A FORM TO EXTEND A TIP OF DEVICE, BUT THE DEVICE WAS BROKEN. THE PROCEDURE WAS COMPLETED USING A BACK-UP DEVICE. A DELAY OF 45 MINUTES WERE REPORTED. NO PATIENT INJURY 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 11130963 ↗
• MalfunctionNov 9, 2020Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT DURING AN ACL PROCEDURE, THE TENDON STRIPPER WAS BROKE. IT IS UNKNOWN IF A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE. NO DELAY AND NO PATIENT INJURIES 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 10814561 ↗
• MalfunctionMar 29, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING SURGERY, WHILE TAKING THE GRAFT (THE PATIENT¿S PERITONEAL LIGAMENT), THE DOCTOR REMOVED THE STRIPPER FROM THE PLACE WHERE THE LIGAMENT WAS TAKEN AND DISCOVERED THE ABSENCE OF A STRIPPER'S PIECE. AN EXTRA INCISION WAS IMMEDIATELY NEEDED TO EXTRACT THE PIECE, IT WAS REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SIGNIFICANT DELAY USING A BACK-UP DEVICE. NO PATIENT INJURY 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 9895111 ↗
• MalfunctionJul 23, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT DURING THE MANIPULATION TO PICK UP THE TENDON IN THE PATIENT'S BODY, THE STRIPPER TIP OF ABOUT 0.5 CM BROKE OFF. THE BROKEN OFF PART WAS NOT REMOVED. THE PATIENT FEELS FINE. AN ADDITIONAL TOOL REMOVAL OPERATION IS NOT PLANNED. A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO DELAY OR PATIENT INJURIES.

  Patient problems: Foreign Body In Patient

  MAUDE report 8816254 ↗
• MalfunctionMay 20, 2019Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE STRIPPER TENDON WAS BROKEN. NO BACK UP DEVICE WAS AVAILABLE, NO PATIENT INJURIES OR DELAY WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8624269 ↗
• MalfunctionApr 22, 2019Corroded

  IT WAS REPORTED THAT AFTER THE PROCEDURE WHEN THE CUSTOMER CLEANED THE STRIPPER, RUST WAS SEEN. NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8535933 ↗
• MalfunctionJan 9, 2018Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING HARVESTING OF THE TENDON, THE TENDON STRIPPER CUT IT OFF. ANOTHER PORTION OF THE TENDON WAS HARVEST. THERE WAS NO DELAY OR PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7176355 ↗