SPEEDSCREW OM-8500Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00817470004076), received between Mar 14, 2018 and Sep 28, 2020 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K101448); 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 16, 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.

• InjurySep 28, 2020Break; Break

  IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR, THE IMPLANT OF THE SPEEDSCREW SEVERED THE SUTURE AND THE SUTURE GOT STUCK INSIDE THE INSERTION DEVICE WHEN IT WAS BEING USED. THE INITIAL ANCHOR WAS LEFT INSIDE THE PATIENT'S ANATOMY. NO DELAY OR OTHER COMPLICATION WERE REPORTED. SMITH AND NEPHEW BACK-UP DEVICE WAS USED IN AN ADDITIONAL BONE HOLE TO COMPLETE THE SURGERY. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Information

  MAUDE report 10597434 ↗
• MalfunctionMar 14, 2018Break

  IT WAS REPORTED THAT WHEN PASSING THE SUTURE THE PULLER BROKE (THE METAL WIRE THAT FEEDS THE SUTURE). THE PHYSICIAN DOUBLE-STACKED A 6.5 ON TOP OF A 5.5, ALL THE PIECES WERE REMOVED FROM THE PATIENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7337043 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K101448. One submission often covers many models, so check the product and lot details in each record.

• Z-0614-2012 · Aug 8, 2011 · Terminated
  OPUS SpeedScrew Implant Product Number OM-6500 is a bone anchor Intended to be used for fixation of soft tissue to bones