NA 214502Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886705003686), received between Aug 16, 2018 and Aug 17, 2018 — classified as 2 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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 17, 2018Material Separation; Material Separation

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE BACKEND OF THE CUSTOMER'S SKID ROD WITH HANDLE 2/0-0 SUTURE (KNOT PUSHER) THAT WAS WELDED TOGETHER CAME APART. THE SALES REP STATED THAT THE DEVICE DID NOT COME APART IN THE PATIENT. THE SALES REP REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP COULD NOT PROVIDE A LOT NUMBER FOR THE DEVICE BUT STATED THAT THE DEVICE IS A COUPLE MONTHS OLD AND USED ONCE OR TWICE. THE SALES REP WAS NOT PRESENT FOR THE CASE THEREFORE COULD NOT PROVIDE ANY FURTHER INFORMATION. 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 7792885 ↗
• MalfunctionAug 16, 2018Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF PROCEDURE, THE CUSTOMER'S SKID ROD WITH HANDLE 2/0-0 SUTURE BROKE AT WHERE THE BLOCK ON THE DEVICE WHERE YOU PUT YOUR THUMB SNAPPED. THE SALES REP STATED THAT WHERE THE DEVICE BROKE STAYED OUTSIDE OF THE PATIENT AND THAT THERE WAS NO DEBRIS IN THE PATIENT. THE SALES REP REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP STATED THE FACILITY DISCARDED THE DEVICE THEREFORE COULD NOT PROVIDE A LOT NUMBER FOR THE DEVICE. THE SALES REP STATED THAT THE DEVICE WAS VERY OLD AND HEAVILY USED IN THE FIELD. THE SALES REP WAS NOT PRESENT FOR THE PROCEDURE THEREFORE COULD NOT PROVIDE ANY FURTHER INFORMATION. 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 7788073 ↗