TARGET 232004Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705010905), received between Jul 27, 2021 and Oct 18, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Degraded” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 18, 2023Degraded; Degraded

  IT WAS REPORTED THAT DURING A KNEE ARTHROSCOPY PROCEDURE ON AN UNSPECIFIED DATE THE TENDONHARV TARGET HARVESTER DEVICE DID NOT CUT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 17960280 ↗
• MalfunctionOct 26, 2021Loose or Intermittent Connection; Use of Device Problem; Material Twisted/Bent; Loose or Intermittent Connection; Use of Device Problem; Material Twisted/Bent

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE TENDONHARV TARGET HARVESTER DEVICE HAD AN UNSPECIFIED DAMAGED/MALFUNCTION. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE DEVICE WAS LOOSE, DID NOT WORK AS INTENDED, AND THE DISPOSABLE CUTTING TIP WAS BENT AND DEFORMED. 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 12698498 ↗
• MalfunctionJul 27, 2021Degraded; Degraded

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE TENDONHARV TARGET HARVESTER DEVICE WAS BLUNT AND DID NOT CUT AS THE SURGEON TRIED TO REMOVE THE SOFT TISSUE GRAFT. THERE WAS NO SURGICAL DELAY NOR ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12228486 ↗