MAGNUM OM-2500Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00817470005592), received between Nov 12, 2018 and Aug 19, 2020 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

3 other recalls cover devices cleared under the same FDA submission (K042584); they may or may not involve this specific model.

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.

• InjuryAug 19, 2020Difficult to Fold, Unfold or Collapse; Mechanical Jam; Difficult to Fold, Unfold or Collapse; Mechanical Jam

  IT WAS REPORTED THAT DURING AN ANTERIOR STABILIZATION THE SUTURE WAS LOAD CORRECTLY INTO THE ANCHOR AND SLACK WAS RATCHETED CORRECTLY IN THE DIRECTIONS OF THE ARROWS. ONCE THE ANCHOR WAS INSERTED INTO THE JOINT AND POSITIONED TO THE PRE DRILLED HOLE THE RATCHET STOP TAKING THE SUTURE, THUS NOT PERFORMING AND UNABLE TO COMPLETE ITS TASK. ANCHOR WAS TAKEN OUT AND ANOTHER WAS OPENED AND WORK PERFECTLY FINE. BECAUSE OF THIS THERE WAS A 5 MINUTE DELAY AND PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE WITH NO FURTHER COMPLICATIONS. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Information

  MAUDE report 10426459 ↗
• InjuryAug 20, 2019Failure to Fire; Failure to Fire

  IT WAS REPORTED THAT DURING AN OPEN SHOULDER STABILIZATION, DURING THE DEPLOYMENT OF THE MINI MAGNUM, THE CUSTOMER STATED THAT THE SNARE¿S SUTURE BROKE EARLY DURING INITIAL SUTURE REDUCTION OR TENSIONING AFTER ANCHOR INSERTION, BEFORE WING DEPLOYMENT. THE CUSTOMER HAD TO REVERT TO TRADITIONAL SUTURE PASSING THROUGH THE LABRUM WHICH IS AN EQUIVALENT TECHNIQUE. OTHER MINI MAGNUM ANCHORS WERE USED WITHOUT ISSUES. NO INJURIES OR DELAYS WERE REPORTED.

  Patient problems: Injury

  MAUDE report 8910067 ↗
• MalfunctionNov 12, 2018Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE DEVICE WAS USED IN THE PROCEDURE AND WHILE THERE CONTINUED TO TURN THE WHEEL TO INSERTED THE ANCHOR INTO THE HOLE THE LINE AT THE WHEEL BROKE ALSO THE SUTURE CUT TOO. THERE WAS NOT ANY PIECES AFTER PROCEDURE INSIDE THE PATIENT AND A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH A SIGNIFICANT DELAY.

  Patient problems: No Code Available

  MAUDE report 8060379 ↗
• MalfunctionNov 12, 2018Break; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE DEVICE WAS USED IN THE PROCEDURE AND WHILE THERE CONTINUED TO TURN THE WHEEL TO INSERTED THE ANCHOR INTO THE HOLE THE LINE AT THE WHEEL BROKE ALSO THE SUTURE CUT TOO. THERE WAS NOT ANY PIECES AFTER PROCEDURE INSIDE THE PATIENT AND A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8060291 ↗
• MalfunctionNov 12, 2018Break; Material Puncture/Hole

  IT WAS REPORTED THAT THE DEVICE WAS USED IN THE PROCEDURE AND WHILE THERE CONTINUED TO TURN THE WHEEL TO INSERTED THE ANCHOR INTO THE HOLE THE LINE AT THE WHEEL BROKE ALSO THE SUTURE CUT TOO. THERE WAS NOT ANY PIECES AFTER PROCEDURE INSIDE THE PATIENT AND A BACKUP DEVICE WAS AVAILABLE TO COMPLETE THE PROCEDURE WITH NO SIGNIFICANT DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8060234 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K042584. One submission often covers many models, so check the product and lot details in each record.

• Z-0628-2012 · Aug 8, 2011 · Terminated
  OPUS Minimagnum Implant Part Number OM-2500 is a bone anchor Intended for rotator cuff repair
• Z-0627-2012 · Aug 8, 2011 · Terminated
  5.0 mm Parafix Part Number 22-5011 is a suture anchor metal Intended for rotator cuff repair.
• Z-0049-2012 · May 11, 2011 · Terminated
  ArthroCare brand MiniMagnum Knotless Fixation Implant Device with Inserter Handle Plus SpeedStitch Magnum Wire Suture Cartridge; Catalog Number: OM-6007; Product is manufactured a