NA 213.024Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10886982153098), received between Jun 24, 2024 and Jun 24, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K000684); 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. How this data works · Data updated Oct 13, 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.

• MalfunctionJun 24, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED DURING SURGERY ON (B)(6) 2024, THE SCREWDRIVER DOES NOT HOLD THE SCREWS. NO INFORMATION IS KNOWN ON PATIENT OR SURGICAL STATUS. THIS REPORT IS FOR ONE SCRDRIVER SHAFT T8 CYLINDRIC W/GROOVE SH THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19595157 ↗
• MalfunctionJun 24, 2024Device-Device Incompatibility; No Apparent Adverse Event; Device-Device Incompatibility; No Apparent Adverse Event

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN FRANCE AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, IN THE PEDIATRIC SURGICAL OPERATING ROOM, IT WAS OBSERVED AFTER A VARIZATION OSTEOTOMY IN A PARAPLEGIC CHILD NOT WALKING, A BALLING HIP REFLECTING A RUPTURE OF THE 2 PROXIMAL LCP 3.5 SCREWS USED TO PLACE AN LCP 3.5 PLATE. THE SCREW HEAD LOCK WAS STILL IN PLACE. THE PATIENT HAD TO UNDERGO A NEW OPERATION OF 2 HOURS TO REFIT A NEW PLATE USING SCREWS OF DIFFERENT REFERENCES, INCLUDING THE ONE IN QUESTION. THIS REPORT INVOLVES ONE (1) 3.5MM LOCKING SCREW SELF-TAPPING 24MM. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19593768 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K000684. One submission often covers many models, so check the product and lot details in each record.

• Z-1800-2015 · May 13, 2015 · Terminated
  3.7mm Cannulated Locking Screws and 3.7mm Cannulated Conical Screws; . the Cannulated Screws are indicated for fixation of fractures, osteotomies, and non-unions of the clavicle,