HEALIX TRANSTEND ORTHOCORD PERCANNULA 222337Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705023844), received between Jul 16, 2018 and Sep 3, 2018 — classified as 3 malfunctions.

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

• MalfunctionSep 3, 2018Break; Break

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP REPORTED THAT DURING A ROTATOR CUFF REPAIR THAT THE CUSTOMER'S HEALIX TRANSTEND BR ANCHOR DUAL SUTURE BROKE MIDBODY WHEN IT WAS ABOUT 1/2 WAY INSERTED INTO THE BONEHOLE. THE SURGEON REMOVED THE BROKEN PIECE OF ANCHOR AND LEFT THE IMPLANT SECURELY CONTAINED WITHIN THE BONEHOLE. THE SURGEON THEN INSERTED A SECOND HEALIX TRANSTEND BR ANCHOR DUAL SUTURE WHICH WOULD NOT ENGAGE FULLY INTO THE BONEHOLE. THIS ANCHOR WAS LEFT SITTING PROUD. THE SURGEON USED THE CANNULA AND MALLET TO BREAK OFF THE PROUD PIECES UNTIL ONLY 1MM OF THE ANCHOR WAS LEFT OUTSIDE OF THE BONE. THE SALES REP REPORTED THAT THE SURGEON REMOVED ALL BROKEN PIECES FROM THE PATIENT JOINT SPACE. THE SURGEON COMPLETED THE PROCEDURE WITH THIS SECOND ANCHOR WITH NO PATIENT CONSEQUENCES BUT THERE WAS A TEN MINUTE DELAY. THE SALES REP REPORTED THAT THE BONEHOLE WAS PREPPED WITH THE HEALIX AWL/TAP AND THAT THE BONE QUALITY WAS HARD. THE SALES REP WAS ABLE TO RETRIEVE A BROKEN PIECE OF THE ANCHOR WHICH WILL BE SENT IN FOR EVALUATION. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILAB

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7840638 ↗
• MalfunctionSep 3, 2018Break; Break

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP REPORTED THAT DURING A ROTATOR CUFF REPAIR THAT THE CUSTOMER'S HEALIX TRANSTEND BR ANCHOR DUAL SUTURE BROKE MIDBODY WHEN IT WAS ABOUT 1/2 WAY INSERTED INTO THE BONEHOLE. THE SURGEON REMOVED THE BROKEN PIECE OF ANCHOR AND LEFT THE IMPLANT SECURELY CONTAINED WITHIN THE BONEHOLE. THE SURGEON THEN INSERTED A SECOND HEALIX TRANSEND BR ANCHOR DUAL SUTURE WHICH WOULD NOT ENGAGE FULLY INTO THE BONEHOLE. THIS ANCHOR WAS LEFT SITTING PROUD. THE SURGEON USED THE CANNULLA AND MALLET TO BREAK OFF THE PROUD PIECES UNTIL ONLY 1MM OF THE ANCHOR WAS LEFT OUTSIDE OF THE BONE. THE SALES REP REPORTED THAT THE SURGEON REMOVED ALL BROKEN PIECES FROM THE PATIENT JOINT SPACE. THE SURGEON COMPLETED THE PROCEDURE WITH THIS SECOND ANCHOR WITH NO PATIENT CONSEQUENCES BUT THERE WAS A TEN MINUTE DELAY. THE SALES REP REPORTED THAT THE BONEHOLE WAS PREPPED WITH THE HEALIX AWL/TAP AND THAT THE BONE QUALITY WAS HARD. THE SALES REP WAS ABLE TO RETRIEVE A BROKEN PIECE OF THE ANCHOR WHICH WILL BE SENT IN FOR EVALUATION. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILAB

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7840618 ↗
• MalfunctionJul 16, 2018Break; Break

  THE SALES REP REPORTED THREE OF HIS HEALIX ANCHORS BROKE DURING A ROTATOR CUFF PROCEDURE. THE SURGEON WAS INSERTING A 3.4MM HEALIX BR ANCHOR WITH A TAP WHEN THE DISTAL TIP BROKE. HE REMOVED ALL BROKEN FRAGMENTS AND WENT TO INSERT A HEALIX TRANSTEND ANCHOR INTO THE SAME BONE HOLE AGAIN WITH THE TAP AND THE DISTAL TIP ALSO BROKE UPON INSERTION. THE SURGEON REMOVED THE BROKEN FRAGMENTS AND DECIDES TO INSERT A 3.4MM HEALIX PEEK ANCHOR. THIS ANCHOR STRIPPED OUT WHILE INSERTING AND COULD NOT BE FULLY INSERTED. WHILE THE SURGEON WAS ATTEMPTING TO UNSCREW THIS ANCHOR, IT BROKE INTO PIECES. THE SURGEON REMOVED A FEW FRAGMENTS BUT ENDED UP TAPPING THE REST OF THE BROKEN FRAGMENTS INTO THE BONE. HE THEN WAS ABLE TO SUCCESSFULLY INSERT A HEALIX ADVANCE ANCHOR WITH NO ISSUES. THERE WERE NO PATIENT CONSEQUENCES. THERE WAS A 5 MINUTE DELAY. THIS WAS A (B)(6) MALE PATIENT WITH HARD BONE AND THIS WAS THE SURGEONS FIRST TIME USING HEALIX TRANSTEND. ALL COMPLAINT DEVICES WERE DISCARDED. NO FURTHER INFORMATION WAS AVAILABLE. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-53664 AND 1221934-2018-53665.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7690871 ↗