NA 03.118.005Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982073341), received between Jan 27, 2025 and Aug 8, 2025 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Material Twisted/Bent” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 8, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE COMPRESSION DISTRACTION POST FOR VA LOCKING SCREW HAS THREADS STRIPPED. THE ISSUE IDENTIFIED DURING INSPECTION. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22751633 ↗
• MalfunctionAug 8, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE COMPRESSION DISTRACTION POST FOR VA LOCKING SCREW HAS THREADS STRIPPED. THE ISSUE IDENTIFIED DURING INSPECTION. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22751629 ↗
• MalfunctionAug 8, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE COMPRESSION DISTRACTION POST FOR VA LOCKING SCREW HAS THREADS STRIPPED. THE ISSUE IDENTIFIED DURING INSPECTION. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22751624 ↗
• MalfunctionAug 8, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE COMPRESSION DISTRACTION POST FOR VA LOCKING SCREW HAS THREADS STRIPPED. THE ISSUE IDENTIFIED DURING INSPECTION. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22751612 ↗
• MalfunctionAug 8, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE COMPRESSION DISTRACTION POST FOR VA LOCKING SCREW HAS THREADS STRIPPED. THE ISSUE IDENTIFIED DURING INSPECTION. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22751600 ↗
• MalfunctionAug 8, 2025Material Twisted/Bent; Material Twisted/Bent

  THE FOLLOWING PRODUCT ISSUES WERE REPORTED TO HAVE OCCURRED ON AN UNKNOWN DATE: DEPTH GAUGE FOR 3.5MM CORTEX SCREWS (X 3) - HOOK IS BROKEN FROM USAGE IN PELVIS RATCHET WRENCH-11MM WIDTH ACROSS FLATS (X 3) - RATCHET DOESN'T WORK. 2.4/2.7 VOLT(TM) SCR RACK 6-90 2 HIGH 1/3 WIDTH ALUM FRAME (X 2) - RACKS ARE FADED FROM WASH AND SOAP. 1. 6MM/0.8MM DOUBLE DRILL GUIDE (X 2) - GUIDE IS BENT. 2. 0MM/1.1MM DOUBLE DRILL GUIDE (X 2) - GUIDE IS BENT. 2.7MM COMPRESSION/DISTRACTION POST/FOR VA-LOCKING HOLE X 6- THREADS ARE STRIPPED. 2.8MM GUIDE WIRE/ 300MM LENGTH FLUTED TIP (X 6)- THREADS STRIPPED. 2.7MM VOLT(TM) CONDYLAR PLATE 6H/58MM (X 1) - PLATE DID NOT LOCK WITH LOCKING SCREW. 2.7MM VOLT(TM) CONDYLAR PLATE 10H/95MM (X 1) PLATE DID NOT LOCK WITH LOCKING SCREW. 15.5MM MONOBLOC FLEXIBLE REAMER - LONG (X 2) - REAMERS ARE DULL. PERIOSTEAL ELEVATOR 14MM STRAIGHT BLADE-ROUND EDGE (X 3)- RUST ON ELEVATOR. THERE WAS NO PATIENT INVOLVEMENT; ISSUES WERE NOTED IN STERILE PROCESSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22748420 ↗
• MalfunctionJan 27, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE DEVICES WERE NOT THREADING IN. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21241730 ↗
• MalfunctionJan 27, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE DEVICES WERE NOT THREADING IN. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21241237 ↗