NA 202.240Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982144119), received between Aug 10, 2018 and Aug 10, 2018 — classified as 1 injury.

5 other recalls cover devices cleared under the same FDA submission (K033995, K050110, K063049); 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 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.

• InjuryAug 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT PREVIOUSLY SUSTAINED AN INJURY TO HIS LEFT ARM AND UNDERWENT A FIXATION OF THE SUPRACONDYLAR HUMERUS FRACTURE ON AN UNSPECIFIED DATE. THE PATIENT REPORTS SUBSEQUENT LOOSENING OF THIS HARDWARE. PATIENT IS NOW SEVERAL YEARS OUT FROM THIS PROCEDURE AND HAS PAIN AND DYSFUNCTION WITH DIFFICULTY LIFTING ON THAT SIDE. X-RAYS REVEALED EVIDENCE OF A NON-UNION WITH GROSS MOTION TO THE FRACTURE SITE, SURGICAL INTERVENTION FOR THE CORRECTION OF THE NON-UNION WAS PERFORMED ON (B)(6) 2015. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2016 FOR REPAIR OF A NONUNION LEFT SUPRACONDYLAR HUMERAL FRACTURE WAS PERFORMED USING PRODUCTS MANUFACTURED BY DEPUY AND MEDTRONIC. IT IS UNKNOWN IF THE DEVICES USED IN ORIGINAL PROCEDURE WERE SYNTHES OR NON SYNTHES DEVICES. DURING THIS PROCEDURE, THE FAILED HARDWARE WAS REMOVED WHICH INCLUDED A PLATE THAT WAS FOUND TO BE BROKEN, ALONG WITH AN UNSPECIFIED AMOUNT OF BROKEN AND FAILED SCREWS. PATIENT WAS AGAIN RETURNED TO SURGERY ON (B)(6) 2016 WHERE SURGEON PERFORMED A CORRECTION OF A NON-UNION OF LEFT SUPRACONDYLAR HUMERUS FRACTURE. DEPUY SYNTHES HARDWARE WAS EXPLANTED AND BONE GRAFT WAS IMPLANTED. SURGEON ALSO PERFORMED NEUROLYSIS OF THE LEFT U

  Patient problems: Not Applicable

  MAUDE report 7774876 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033995, K050110, K063049. One submission often covers many models, so check the product and lot details in each record.

• Z-2389-2016 · Jun 28, 2016 · Terminated
  Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Synthes 2.4mm Titanium Locking Screws Self-Tapping with Stardrive Recess 12mm, Plate, Fixation, Bone,
• Z-0323-2016 · Nov 2, 2015 · Terminated
  2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone frag
• Z-0167-2016 · Oct 6, 2015 · Terminated
  2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantati
• Z-0380-2014 · Jul 31, 2013 · Terminated
  2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragmen
• Z-2278-2013 · Mar 8, 2013 · Terminated
  Synthes 3.5 MM LCP(R) Distal Humerus System The Synthes 3.5 MM LCP Distal Humerus System is intended for fixation of fractures of the distal humerus, olecranon, and ulna in adults