NA 394.06Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982199485), received between May 16, 2024 and May 16, 2024 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: WEHBÉ, M.A. ET AL (1995), ULNAR SHORTENING USING THE AO SMALL DISTRACTOR, J HAND SURG VOL. 20A (XX), PAGES 959-964 (USA). THE STUDY DEMONSTRATES THAT ULNAR TRANSVERSE SHORTENING OSTEOTOMY WITH EXTERNAL COMPRESSION AND PLATING IS A SIMPLE AND EFFECTIVE METHOD OF ULNAR SHORTENING, AND THAT HIGHLY PRECISE AND COMPLEX INSTRUMENTATION IS NOT ESSENTIAL. DURING THE STUDY, A TOTAL OF 24 PATIENTS (12 MALE AND 12 FEMALE) AND A MEAN AGE OF 38 YEARS WERE INCLUDED IN THE STUDY. THESE PATIENTS HAD ULNAR IMPACTION SYNDROME AND UNDERWENT ULNAR SHORTENING OSTEOTOMY. PATIENTS WERE REVIEWED RETROSPECTIVELY TO EVALUATE A TECHNIQUE USING THE AO SMALL DISTRACTOR (SYNTHES) AND 2.7-MM DCP. ALL WERE FOLLOWED UP TO AN AVERAGE OF 32 MONTHS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: - (N=1) CONTINUOUS WRIST PAIN - (N=3) DELAYED UNION - (N=1) FELL AFTER PLATE REMOVAL AND FRACTURED HER ULNA THROUGH THE OSTEOTOMY LINE (WAS RE-PLATED AND HEALED) - (N=13) PAIN DIRECTLY OVER THE PLATE THIS REPORT IS FOR AN UNKNOWN SYNTHES SMALL DISTRACTOR. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS IS REPORT 1

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 19336523 ↗