NA 254730Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10886705013739), received between Nov 26, 2018 and Jun 12, 2026 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Degraded” (7 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2026Degraded

  IT WAS REPORTED THAT DURING AN UNSPECIFIED ARTHROSCOPIC PROCEDURE THE TENDON HARV CLOSED STRIPPER DEVICE WAS VERY DULL. 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 25486926 ↗
• MalfunctionJun 7, 2024Degraded; Degraded

  IT WAS REPORTED THAT THE TENDON HARV CLOSED STRIPPER EA DEVICE DID NOT CUT. IT WAS NOT REPORTED IF THE DEVICE WAS USED IN SURGERY, OR IF THERE WAS PATIENT INVOLVEMENT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL PROCEDURE, OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. IT WAS NOT REPORTED IF THERE WERE ANY INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19486523 ↗
• MalfunctionMay 20, 2024Degraded; Degraded

  IT WAS REPORTED BY THE SALES REP IN COLOMBIA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024 THE TENDON HARV CLOSED STRIPPER EA DEVICE AND RIGIDLOOP REAMER 4.5MM DEVICE DRILL DID NOT CUT AND THE LASER MARKS WERE NO LONGER VISIBLE ON THE DRILL AND THE DOCTOR LIKED TO USE THE DRILL TO MEASURE THE DEPTH OF THE FIRST FEMORAL TUNNEL FOR THE PASSAGE OF THE RIGID LOOP PLATE. THERE WERE NO REPORTS OF ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19352087 ↗
• MalfunctionNov 30, 2023Degraded; Degraded

  IT WAS REPORTED FROM THE SALES REP THAT DURING PRE-OP IT WAS OBSERVED THAT THE TENDON HARV CLOSED STRIPPER EA DEVICE WAS NOTED AS NOT SHARP ENOUGH. NEW TENDON STRIPPER WAS USE TO COMPLETE PROCEDURE. NO SURGICAL DELAY OR PATIENT CONSEQUENCES REPORTED. THIS EVENT DID NOT OCCUR DURING SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18239888 ↗
• MalfunctionJun 29, 2023Degraded; Degraded

  IT WAS REPORTED BY SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR PROCEDURE ON(B)(6) 2023, IT WAS OBSERVED THAT THE TENDON HARVESTER DEVICE WAS NOT SHARP ENOUGH. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS COMPLAINT INVOLVES X (X) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17226019 ↗
• MalfunctionSep 29, 2022Degraded; Degraded

  IT WAS REPORTED BY SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE TIP ON THE TENDON HARVESTER DEVICE WAS DULL THAT IT COULD NOT HARVEST THE TENDON. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 15508827 ↗
• MalfunctionMay 4, 2022Material Deformation; Material Deformation

  IT WAS REPORTED BY THE AFFILIATE IN (B)(4) THAT PREOPERATIVELY TO AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE TENDON HARV CLOSED STRIPPER DEVICE WAS BENT AND COULD NOT BE USED. 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 14279379 ↗
• MalfunctionSep 13, 2021Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE TENDON HARV CLOSED STRIPPER DEVICE WAS BENT. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 12461582 ↗
• InjuryNov 16, 2020Degraded; Dull, Blunt; Degraded; Dull, Blunt

  IT WAS REPORTED BY AFFILIATE VIA COMPLAINT SUBMISSION TOOL THAT WHILE HARVESTING THE SEMITENDINOSUS TENDON(TENDON HARV CLOSED STRIPPER EA), THE TENDON TEAR PREMATURELY SO THE TENDON WAS TOO SHORT TO USE AS A REPLACEMENT FOR THE ACL RECONSTRUCTION. THE SURGEON COMPLAIN THAT A PART OF THIS PROBLEM WAS THAT THE STRIPPER WAS NOT SHARP ENOUGH. SURGEON HAD TO HARVEST A PART OF THE TRACTUS ILIOTIBIALIS. 30 MINUTES DELAY. NO PATIENT CONSEQUENCES. THE DEVICE IS AVAILABLE FOR EVALUATION.

  Patient problems: Not Applicable; Tissue Damage; Unspecified Tissue Injury

  MAUDE report 10843366 ↗
• MalfunctionNov 26, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT FOLLOWING AN ACL RECONSTRUCTION PROCEDURE THE SALES REP'S TENDON HARVESTER CLOSED STRIPPER LOOP AT THE DISTAL TIP BROKE OFF DURING STERILIZATION. THE SALES REP DID NOT KNOW HOW THE DEVICE BROKE. THE CASE WAS COMPLETED WITH THIS DEVICE WITH NO PATIENT HARM OR DELAY. THE SALES REP COULD NOT PROVIDE A LOT NUMBER FOR THE DEVICE. THE DEVICE WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8104667 ↗