NA 201.368.97Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982141927), received between Oct 22, 2018 and Aug 24, 2020 — classified as 4 injuries.

4 other recalls cover devices cleared under the same FDA submission (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 18, 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.

• InjuryAug 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION WITH PLATES AND SCREWS AND COMPRESSION DUE TO NONUNION LEFT PROXIMAL ULNA S/P ORIF MONTEGGIA FRACTURE SUBLUXATION. ON (B)(6) 2017, THE PATIENT UNDERWENT AN OPEN REDUCTION AND INTERNAL FIXATION OF THE COMMINUTED LEFT PROXIMAL ULNA AND WHERE A SYNTHES DEVICE WAS IMPLANTED. PRIOR TO THE REPORTED EVENT, THE PATIENT TRIPPED OVER A CURB AND FELL HER ON HER LEFT UPPER EXTREMITY RESULTING TO AN IMMEDIATE SEVERE PAIN. CONCOMITANT DEVICES REPORTED: 2.0MM CORTEX SCREW SLF-TPNG WITH STARDRIVE RECESS 6MM (PART NUMBER 201.356.97, LOT UNKNOWN, QUANTITY 1), 2.0MM CORTEX SCREW SLF-TPNG WITH STARDRIVE RECESS 12MM (PART NUMBER 201.362.97, LOT UNKNOWN, QUANTITY 1), 2.0MM CORTEX SCREW SLF-TPNG WITH STARDRIVE RECESS 16MM (PART NUMBER 201.366.97, LOT UNKNOWN, QUANTITY 1), 2.0MM CORTEX SCREW SLF-TPNG WITH STARDRIVE RECESS 20MM (PART NUMBER 201.370.97, LOT UNKNOWN, QUANTITY 1), 2.0MM LCP(TM) PLATE 4 HOLES/31MM (PART NUMBER 247.344, LOT UNKNOWN, QUANTITY 1), 3.5MM CORTEX SCREW SELF-TAPPING 16MM (PART NUMBER 204.816, LOT UNKNOWN, QUANTITY 1), 3.5MM CORTEX SCREW SELF-TAPPING 20MM (PART NUMBER 204.82, LOT UNKNOWN, QUANT

  Patient problems: Bone Fracture(s); No Code Available; Pain

  MAUDE report 10442567 ↗
• InjuryFeb 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A REMOVAL OF THE VARIABLE ANGLE (VA) LOCKING T-PLATE AND SCREWS DUE TO AN INFECTION. INITIALLY, THE PATIENT WAS IMPLANTED WITH THE REPORTED DEVICES ON (B)(6) 2019. DURING THE PROCEDURE, ALL THE ORIGINAL IMPLANTS WERE SUCCESSFULLY REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT SURGICAL DELAY. PATIENT STATUS WAS UNKNOWN. THIS IS REPORT 6 OF 7 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 9739078 ↗
• InjuryJun 12, 2019Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2015, THE PATIENT UNDERWENT A REMOVAL PROCEDURE OF PAINFUL HARDWARE PROXIMAL ASPECT OF RIGHT ULNA. ON (B)(6) 2014, THE PATIENT SUSTAINED AN INJURY AFTER TRIPPING AND FALLING FROM A STANDING POSITION AND LANDED DIRECTLY INTO THE RIGHT ELBOW. THE PATIENT HAD THE ONSET OF PAIN AND INABILITY TO FULLY USE THE ELBOW. SUBSEQUENT X-RAYS WERE TAKEN AND REVEALED A DISPLACED, DISTRACTED OLECRANON FRACTURE, WITH A COMMINUTED RIGHT RADIAL HEAD FRACTURE. THE PATIENT ALSO COMPLAINS OF PAIN IN THE RIGHT PROXIMAL HUMERUS. THE PATIENT WAS ORIGINALLY IMPLANTED ON (B)(6) 2014 WITH ONE (1) VARIABLE ANGLE ¿ LOCKING COMPRESSION PLATE (VA-LCP) PROXIMAL, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8. STARDRIVE RECESS 14MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8. STARDRIVE RECESS 16MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8. STARDRIVE RECESS 20MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8. STARDRIVE RECESS 24MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8. STARDRIVE RECESS 30MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8. STARDRIVE RECESS 40MM, ONE (1) LOCKING SCREW SELF-TAPPING WITH

  Patient problems: Bone Fracture(s); Loss of Range of Motion; No Code Available; Pain

  MAUDE report 8692744 ↗
• InjuryOct 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE IMPLANTATION PROCEDURE ON (B)(6) 2015, THE PATIENT UNDERWENT AN OPEN TREATMENT OF LEFT ELBOW DISLOCATION WITH PRIMARY REPAIR OF ANTERIOR CAPSULAR AVULSION INJURY, A LEFT ELBOW RADIAL HEAD REPLACEMENT FOR FRACTURE AND A LEFT ELBOW PRIMARY REPAIR OF LATERAL ULNAR COLLATERAL LIGAMENT. ONCE THE INJURY WAS VISIBLE AFTER SUITABLE INCISION WAS MADE, THE SURGEON FOUND AN OBVIOUS CLEAR SOMATIC AVULSION OF THE LATERAL ULNAR COLLATERAL LIGAMENT OFF THE HUMORAL ATTACHMENT POINT, BUT THIS APPEARED TO BE INTACT DISTALLY ON THE ULNA. RADIAL HEAD FRACTURE SHOWED ALMOST FRAGMENTS. THE SURGEON BELIEVED THAT A PRIMARY OPEN REDUCTION INTERNAL FIXATION MIGHT BE THE AMENABLE, AND HENCE PROCEEDED TO ATTEMPT THE SAME WITH THE GOAL OF PRESERVING NATIVE BONE FOR THE PATIENT. AFTER CLEANING THE WOUND SITE FOR BETTER VISUALIZATION OF THE OPERATING SITE, THE ARTICULAR SURFACE WAS LAGGED BACK TOGETHER WITH TWO (2) 2.0 MM LAG SCREWS, WITH HEADS COUNTERSUNK. THIS NOW STABILIZED THE ARTICULAR BLOCKS, WAS DIS-IMPACTED AND THEN A RADIAL HEAD LOCKING PLATE WAS APPLIED. ADDITIONAL LATERAL RADIOGRAPHS AFTER THE PROVISIONAL STABILIZATION SHOWED A NEAR-PERFECT REDUCTION; HOWEVER, THE ELBOW

  Patient problems: No Code Available

  MAUDE report 7992169 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under 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