NA 202.230Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10886982144065), received between Nov 5, 2019 and Nov 5, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Device-Device Incompatibility” (1 report).

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.

• InjuryNov 5, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING PLATING OF A PILON FRACTURE, THE SURGEON USED 3.5 MM LOCKING COMPRESSION PLATE (LCP) ANTEROLATERAL DISTAL TIBIA PLATE 9 HOLES RIGHT. THE PLATE ACCEPTS 3.5 MM LOCKING AND CORTICAL SCREWS PROXIMALLY AND 2.7 MM LOCKING DISTALLY. THERE WERE NO ISSUES WITH ANY OF THE 3.5 MM SCREWS PROXIMALLY, BUT NONE OF THE 2.7 MM LOCKING SCREWS HE DRILLED AND INSERTED DISTALLY ACTUALLY LOCKED INTO THE PLATE, THEY JUST SPUN. THE SURGEON DRILLED AND ATTEMPTED TO INSERT FOUR (4) OR FIVE (5) 2.7 MM LOCKING SCREWS DISTALLY, ALL OF WHICH FAILED, BEFORE RESORTING TO USING 2.7 MM CORTICAL SCREWS INSTEAD. FOUR (4) OF THE 2.7 MM LOCKING SCREW DID NOT LOCK IN THE DISTAL HOLES OF THE PLATE. THE 3.5 MM LOCKING SCREWS DID LOCK IN THE PROXIMAL PART OF THE PLATE. HE USED THE APPROPRIATE LOCKING DRILL GUIDE, DRILL, AND SCREWS. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS GOOD. CONCOMITANT DEVICE REPORTED: UNKNOWN LOCKING DRILL GUIDE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1), UNKNOWN 2.0 DRILL BIT (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS REPORT IS FOR 2 OF 5 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9279691 ↗

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