NA 332.352Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982192721), received between Apr 5, 2018 and Feb 19, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2026Material Integrity Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT REMOVAL SURGERY FOR ANGLE BLADE PLATE. THE PRODUCT IS BELIEVED TO HAVE BEEN USED AND DAMAGED DURING SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE PRODUCT IN WAS RETURNED, AND ON DECEMBER 9, 2025, THE DAMAGE WAS CONFIRMED AT THE DISTRIBUTION CENTER. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 24389142 ↗
• MalfunctionJun 30, 2021Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING LOAN KIT INSPECTION, THE TECHNICIAN NOTICED THAT A LOCKING SCREW ON AN INSTRUMENT HAD SNAPPED OFF. THIS REPORT IS FOR AN INSERTER FOR BIFURCATED/INFANT AND TODDLER OSTEOTOMY PLATES. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12093172 ↗
• MalfunctionMar 26, 2020Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED ON (B)(6) 2020, IT WAS NOTICED THAT BOTH SCREWS IN THE TWO (2) INSERTER/EXTRACTOR FOR CHILD HIP PLATE WERE BOUND OR CROSS-THREADED MAKING THEM UNUSABLE. THE SALES CONSULTANT ATTEMPTED TO UNSCREW THE ONE IN THE INFANT INSERTER/EXTRACTOR, BUT THE SCREW HEAD SNAPPED OFF. THIS DID NOT IMPACT A SURGERY, AS THE SALES CONSULTANT WAS CHECKING THE SET BEFOREHAND. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) INSERTER FOR BIFURCATED/INFANT AND TODDLER OSTEOTOMY PLATES. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9882465 ↗
• MalfunctionApr 5, 2018Break; Break

  (B)(4) REPORTED THAT A DEPTH GAUGE FOR LOCKING SCREW WAS NOTED IN STERILE PROCESSING TO BE BENT BEYOND REPAIR. IT WAS ADDITIONALLY NOTED DURING STERILE PROCESSING THAT AN INSERTER FOR BIFURCATED / INFANT AND TODDLER OSTEOTOMY PLATES (REPORTED AS A GUIDE) WAS ALSO BROKEN. THERE IS NO PATIENT INVOLVEMENT. (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7400152 ↗