LCP 222.229Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10886982156693), received between Mar 15, 2018 and Sep 18, 2018 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2018Break; Break

  IT WAS REPORTED DURING THE ROTATOR CUFF NEOPLASTY THE IMPLANT BROKE. THE BROKEN PIECE DIDN'T FALL INTO PATIENT. THEY CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY DURING PROCEDURE. ADDITIONAL INFORMATION RECEIVED VIA EMAIL FROM THE AFFILIATE ON DECEMBER 30, 2015: IT WAS NOTED THE PROCEDURE WAS COMPLETED BY EITHER USING THE SAME BONE HOLE OR CREATING AN ADDITIONAL ONE. THE PROCEDURE WAS NOT EXTENDED FOR MORE THAN THIRTY (30) MINUTES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7885257 ↗
• MalfunctionAug 31, 2018Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, THE DISTAL TIP OF THE CUSTOMER'S HEALIX BR 4.5MM ANCHOR WITH ORTHOCORD BROKE UPON INSERTION. THE SURGEON FULLY REMOVED THE BROKEN PIECE AND COMPLETED THE PROCEDURE WITH ANOTHER SAME TYPE, SAME SIZE ANCHOR IN THE SAME BONE HOLE. THE SALES REP REPORTED THAT THE SURGEON WAS NOT OFF-AXIS AND THAT THE BONE QUALITY WAS GOOD. THE CUSTOMER ALREADY DISCARDED THE COMPLAINT DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7838835 ↗
• MalfunctionAug 1, 2018Break; Break

  SCREW BREAKAGE. IT WAS REPORTED THAT THE SCREW BROKE IN UNKNOWN PROCEDURE. THE BROKEN PIECE WAS RETRIEVED FROM PATIENT. CHANGED NEW ONE TO COMPLETE. THERE WAS NO ADVERSE EVENT ON PATIENT REPORT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7739832 ↗
• MalfunctionJul 19, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT THE DISTAL PORTION OF THE CUSTOMER'S 4.5MM HEALIX BR ANCHOR BROKE UPON INSERTION INTO THE BONE HOLE DURING A SHOULDER SURGICAL PROCEDURE. THE SURGEON REMOVED THE ANCHOR AND ALL BROKEN PIECES AND DISCARDED THEM. HE THEN CREATED A NEW BONE HOLE AND INSERTED ANOTHER ANCHOR TO COMPLETE THE PROCEDURE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE BONE QUALITY WAS AVERAGE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7704197 ↗
• MalfunctionJul 9, 2018Fracture; Fracture

  IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE ANCHOR DEVICE BROKE. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE; HOWEVER, IT WAS REPORTED THAT A SPARE DEVICE WAS USED TO COMPLETE THE PROCEDURE IN THE SAME BONE HOLE. IT WAS REPORTED THAT THE BROKEN PIECE WAS RETRIEVED FROM PATIENT. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO 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 7669714 ↗
• InjuryMar 15, 2018Break; Break

  ADDITIONAL INFORMATION RECEIVED ON 10/26/2018 STATED THAT THE PATIENT HAS GOOD BONE QUALITY. THE PLACEMENT WAS DONE ACCORDING TO TECHNIQUE AND WASN'T OFF AXIS. IT WAS REPORTED THAT A FRAGMENT WAS REMOVED FROM THE PATIENT AND AN ADDITIONAL BONE HOLE WAS MADE TO COMPLETE THE PROCEDURE USING ANCHORS FROM ANOTHER COMPANY. THERE WAS A DELAY ABOUT 10 MINUTES. THERE WAS NO CONSEQUENCES FOR THE PATIENT. THE ITEM WAS RETURNED ON FEBRUARY 28TH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7341741 ↗