TENOLOK, HI-FI T60SRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10845854043790), received between Dec 17, 2018 and May 30, 2023 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (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 18, 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.

• InjuryMay 30, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  THE DISTRIBUTOR REPORTED ON BEHALF OF THE CUSTOMER THAT THE T60S 6.0MM TENOLOK TENODESIS ANCHOR WITH ONE NO. 2 HI-FI SUTURE WAS IMPLANTED ON (B)(6) 2023 AND ON (B)(6) 2023 A REVISION BICEPS REPAIR PROCEDURE WAS COMPLETED AS THE DR. ¿HAD A TENOLOK FAIL AFTER THE ORIGINAL SURGERY ON (B)(6).¿. THE ORIGINAL SURGERY WAS A BICEPS REPAIR THAT WAS COMPLETED WITH NO COMPLICATIONS. THE PATIENT IS RECOVERING AND NO EXTENDED STAY AT THE HOSPITAL WAS REQUIRED. THIS REPORT IS BEING RAISED DUE TO THE REPORTED INJURY OF REVISION SURGERY NEEDED FOR A FAILED IMPLANT.

  Patient problems: Failure of Implant

  MAUDE report 17018479 ↗
• MalfunctionSep 13, 2021Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, T60S, WAS BEING USED ON (B)(6) 2021 DURING A BICEPS TENODESIS PROCEDURE AND THE ANCHOR HOLE WAS DRILLED AND ANCHOR AND TENDON INSERTED, ANCHOR DID NOT DEPLOY WITH USUAL 'CRACKING' SOUND. UPON EXAMINATION AFTER THE INSERTED WAS REMOVED THE ANCHOR WAS IN TWO PARTS AND NOT HOLDING THE TENDON. THERE WAS NO REPORT OF IMPACT OR INJURY TO THE FEMALE PATIENT. THERE WAS A 5 MINUTE DELAY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER TENOLOK OF THE SAME LOT NUMBER. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12460118 ↗
• MalfunctionJul 1, 2020Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE T60S WAS BEING USED ON (B)(6) 2020 DURING A BICEPTS TENODESIS PROCEDURE WHEN THE ANCHOR BROKE INTO THREE PIECES WHILE BEING IMPLANTED. THE SURGEON WAS REPORTED AS INSERTING THE ANCHOR PER TECHNIQUE GUIDE WHEN HE TRIED TO DEPLOY THE ANCHOR. AN AUDIBLE POP WAS HEARD, AND THE ANCHOR HAD BROKEN INTO THREE PIECES. A GRASPER WAS USED TO REMOVE THE PIECES OF THE ANCHOR FROM THE PATIENT. THE PROCEDURE WAS COMPLETED AS PLANNED AFTER A 30-MINUTE DELAY. THERE WAS NO REPORT OF INJURY TO THE PATIENT, NO MEDICAL INTERVENTION AND NO HOSPITALIZATION OCCURRED. THE PATIENT IS LISTED AS RECOVERING. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10219826 ↗
• MalfunctionOct 2, 2019Human-Device Interface Problem; No Apparent Adverse Event; Human-Device Interface Problem; No Apparent Adverse Event

  THE CUSTOMER REPRESENTATIVE REPORTED ON BEHALF OF THE FACILITY THAT THE T60S, 6.0MM TENOLOK ANCHOR, WHICH WAS EXPIRED, WAS IMPLANTED INTO A PATIENT ON (B)(6) 2019. THE EXPIRATION DATE WAS 06/2019. THE CUSTOMER HAS SPOKEN WITH THEIR ORTHO TECH ABOUT THESE IMPLANTS AND THEY SHOULD BE HAVING MONTHLY CONSIGNMENT CHECKS, WHICH I BELIEVE WAS DONE IN THE LAST TWO WEEKS. THIS REPORT IS BEING RAISED ON THE BASIS OF DEVICE MALFUNCTION DUE TO AN EXPIRED IMPLANT BEING IMPLANTED INTO A PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9147555 ↗
• MalfunctionDec 17, 2018Break; Break

  THE CUSTOMER REPORTED AN ISSUE WITH THE 6.0MM TENOLOK TENODESIS ANCHOR WITH ONE NO. 2 HI-FI SUTURE ITEM # T60S, LOT # 929906 THAT OCCURRED DURING BICEPS TENODESIS PROCEDURE INVOLVING A (B)(6) MALE ((B)(6)) ON (B)(6) 2018. IT WAS REPORTED THAT THE SURGEON HAD INSERTED THE FIRST ANCHOR INTO THE DRILLED HOLE ON THE BI-CIPITAL GROOVE AND STARTED TO TIGHTEN THE TENDON IN THE DRILLED HOLE. THE SURGEON WAS TIGHTENING THE BLACK HANDLE AT THE TOP OF THE TENOLOK TO SECURE THE TENDON INTO THE PATIENT BONE WHEN THE ANCHOR BROKE. THE SURGERY WAS AN OPEN PROCEDURE SO RETRIEVERS WERE USED TO TAKE THE PIECES OUT FROM THE PATIENT AND NO FRAGMENTS REMAINED IN THE PATIENT. THERE WAS NO REPORT OF IMPACT OR INJURY TO THE PATIENT AND NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT STATUS AT TIME OF THIS REPORT IS GOOD. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO REPORTED DELAY USING AN ALTERNATIVE TENOLOK ANCHOR. DUE TO PREVIOUS FILINGS THIS EVENT WILL BE REPORTED AND IS BEING RAISED ON THE BASIS OF A DEVICE MALFUNCTION WITH POTENTIAL OF INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8168729 ↗