DJO SURGICAL 010-55-030Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888912069984), received between Sep 19, 2018 and Apr 30, 2020 — classified as 1 injury, 1 malfunction.

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

2 other recalls cover devices cleared under the same FDA submission (K931665); 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2020Break

  INSTRUMENT FAILURE - THE 30MM SCREW HEAD BROKE UPON IMPLANTATION. 70 PERCENTAGE OF IT STAYED IN THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10013935 ↗
• InjurySep 19, 2018Break; Material Fragmentation

  REPORTED INCIDENT - DURING A LEFT TOTAL ARTHROSCOPY, A PIECE OF ONE OF THE TITANIUM SCREWS USED FOR THE PROCEDURE BROKE AFTER INSERTION. THE BROKEN PIECE (HEAD OF THE SCREW) WAS REMOVED FROM THE SURGICAL FIELD AND SEQUESTERED WITH THE MATERIALS SUPERVISOR ALONG WITH THE MANUFACTURER'S PACKAGING. THE BODY OF THE SCREW REMAINED INTACT AND HIP FIXATION WAS ESTABLISHED. THE SURGEON FELT THAT THE HIP SOCKET WAS STABLE AND DID NOT ELECT TO PLACE ANY FURTHER SCREWS. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7889265 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K931665. One submission often covers many models, so check the product and lot details in each record.

• Z-0139-2013 · Sep 28, 2012 · Terminated
  6.5mm Cancellous Bone Screw Intended to be used for the fixation of the acetabular shell or fracture repair.
• Z-2146-2012 · Jul 16, 2012 · Terminated
  djo surgical Screw 6.5 mm, Sz 25mm, low profile. Product is intended for the fixation of the acetabular shell or fracture repair