NA 232002Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886705010899), received between Feb 22, 2018 and Aug 6, 2021 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 6, 2021Degraded; Degraded

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT A GRAFT WAS TORN WHEN THE SURGEON WAS USING THE TENDONHARV PIGTAIL PEELER DEVICE. THE PROCEDURE WAS COMPLETED WITHIN 30 MINUTES DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12289882 ↗
• InjuryJul 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 GRAFT WAS TORN WHEN THE SURGEON WAS HARVESTING A TENDON GRAFT USING THE TENDONHARV PIGTAIL PEELER DEVICE. IT WAS REPORTED THAT COMPARTMENT SYNDROME DEVELOPED IN THE LOWER LEG OF THE PATIENT ON THE TENDON SIDE AS THE SURGERY LASTED FOR A LONG TIME. THE PROCEDURE WAS COMPLETED WITH LESS THAN 30-MINUTE DELAY. THE STATUS OF THE PATIENT POST-SURGERY WAS UNKNOWN. THE DEVICE WAS BRAND NEW AND ITS FIRST USE WHEN THE ISSUE OCCURRED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unspecified Tissue Injury

  MAUDE report 12240596 ↗
• MalfunctionJul 30, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) SURGERY ON (B)(6) 2020, IT WAS OBSERVED THAT THE TENDONHARV PIGTAIL PEELER *EA DEVICE WAS DIFFICULT TO USE WHILE TAKING THE GRACILIS AND SEMITENDINOSUS GRAFTS. ACCORDING TO THE REPORT, DUE TO ITS DIFFICULTY, THE SAME GRAFT WAS DAMAGED WITH THE DISTAL SPIRAL-SHAPED PART OF THE DEVICE. THERE WAS A 30 MINUTE DELAY IN THE SURGICAL PROCEDURE. THE GRAFT WAS RECOVERED USING THE SAME DEVICE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Not Applicable

  MAUDE report 10345273 ↗
• MalfunctionApr 6, 2020Break; Break

  IT WAS REPORTED BY THE SALES REP VIA COMPLAINT SUBMISSION TOOL THAT DURING AN UNKNOWN PROCEDURE THE TENDONHARV PIGTAIL PEELER EA BROKE OFF. NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9930649 ↗
• MalfunctionJan 6, 2020Dull, Blunt; Dull, Blunt

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNKNOWN PROCEDURE, THE TENDONHARV PIGTAIL PEELER *EA TORE THE GRAFT AND THE PROCEDURE HAD TO BE CANCELLED. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9553222 ↗
• MalfunctionNov 26, 2019Failure to Advance; Failure to Advance

  THIS IS REPORT 1 OF 3 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN COLOMBIA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE TENDONHARV PIGTAIL PEELER *EA DEVICE TORE THE GRAFT AND THE PROCEDURE HAD TO BE CANCELLED. IT WAS FURTHER REPORTED THAT THE RESTORE FULLFLUTE REAM 8MM *EA DEVICE WAS NOT ABLE TO CUT, AND ANOTHER RESTORE FULLFLUTE REAM 8MM *EA DEVICE WAS USED TO TRY TO MAKE THE TIBIAL TUNNEL; HOWEVER, IT WAS IN THE SAME CONDITION THAT IT WAS NOT ABLE TO CUT EITHER. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9375383 ↗
• MalfunctionFeb 22, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE EXTRACTOR (STRIPPER) BURST THE DOCTOR'S GRAFT. THE DOCTOR HAS COMPLAINED SEVERAL TIMES ABOUT THIS ITEM. THE PROCEDURE WAS A KNEE ARTHROSCOPY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7288914 ↗