NA 201.770Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886982142788), received between Oct 19, 2018 and Dec 23, 2021 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (9 reports).

10 other recalls cover devices cleared under the same FDA submission (K002271, K063049, K102694, K103243, K112583); 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, BEFORE THE CASE BEGAN, THE SCRUB TECH WAS CHECKING SCREW FITMENT OF 2.4 CORTEX SCREWS THROUGH THE GUIDE BLOCK OF 2.4 VA-LCP DISTAL RADIUS PLATE AND NOTICED THAT SCREW HEADS WERE NOT FITTING THROUGH GUIDE BLOCK 2.4 SCREW HOLES DISTALLY. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES (3) DEVICES. THIS REPORT IS FOR (1) 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 20MM. THIS REPORT IS 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13080196 ↗
• MalfunctionDec 23, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, BEFORE THE CASE BEGAN, THE SCRUB TECH WAS CHECKING SCREW FITMENT OF 2.4 CORTEX SCREWS THROUGH THE GUIDE BLOCK OF 2.4 VA-LCP DISTAL RADIUS PLATE AND NOTICED THAT SCREW HEADS WERE NOT FITTING THROUGH GUIDE BLOCK 2.4 SCREW HOLES DISTALLY. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS FOR (1) 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 20MM. THIS REPORT IS 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13080182 ↗
• InjuryNov 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE SURGEON WAS PERFORMING A PRE-PLANNED BONE GRAFTING OF A DISTAL TIBIA NON UNION AND REMOVED THE 2.4MM CORTEX SCREW. THIS REPORT IS FOR ONE (1) 2.4 CORTEX SCREW SLF-TPNG T8 SD REC 20. THIS IS REPORT 1 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12789116 ↗
• MalfunctionOct 28, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, SOME OF THE 2.4 MM CORTEX SCREWS WERE NOT FITTING THROUGH THE PLATE GUIDES FOR THE TWO COLUMN VARIABLE ANGLE DISTAL RADIUS PLATES. THE SET WAS OPENED AND TESTED THE THREE (3) 2.4 MM CORTEX SCREWS 20 MM, TWO (2) 2.4 MM CORTEX 22 MM, AND ONE (1) 2.4 MM CORTEX 24 MM. THE 2.4 MM CORTEX SCREWS WOULD NOT FIT THROUGH THE GUIDE BLOCK FOR TWO-COLUMN PLATE 6 HOLE HEAD, GUIDE BLOCK FOR TWO-COLUMN PLATE 7 HOLE HEAD, NOR THE GUIDE BLOCK FOR TWO-COLUMN PLATE NARROW 6 HOLE. THE REST OF THE 2.4 MM CORTEX SCREWS DID. THE ISSUE WAS FOUND IN STERILE PROCESSING DEPARTMENT (SPD). THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICES REPORTED: UNKNOWN CORTEX SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN) THIS COMPLAINT INVOLVES NINE (9) DEVICES. THIS IS 8 OF 9 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9244335 ↗
• MalfunctionOct 28, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, SOME OF THE 2.4MM CORTEX SCREWS WERE NOT FITTING THROUGH THE PLATE GUIDES FOR THE TWO COLUMN VARIABLE ANGLE DISTAL RADIUS PLATES. THE SET WAS OPENED AND TESTED THE THREE (3) 2.4MM CORTEX SCREWS 20MM, TWO (2) 2.4MM CORTEX 22MM, AND ONE (1) 2.4MM CORTEX 24MM. THE 2.4MM CORTEX SCREWS WOULD NOT FIT THROUGH THE GUIDE BLOCK FOR TWO-COLUMN PLATE 6 HOLE HEAD, GUIDE BLOCK FOR TWO-COLUMN PLATE 7 HOLE HEAD, NOR THE GUIDE BLOCK FOR TWO-COLUMN PLATE NARROW 6 HOLE. THE REST OF THE 2.4MM CORTEX SCREWS DID. THE ISSUE WAS FOUND IN STERILE PROCESSING DEPARTMENT (SPD). THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICES REPORTED: UNKNOWN CORTEX SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS COMPLAINT INVOLVES NINE (9) DEVICES. THIS IS 7 OF 9 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9244334 ↗
• MalfunctionOct 28, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, SOME OF THE 2.4MM CORTEX SCREWS WERE NOT FITTING THROUGH THE PLATE GUIDES FOR THE TWO COLUMN VARIABLE ANGLE DISTAL RADIUS PLATES. THE SET WAS OPENED AND TESTED THE THREE (3) 2.4MM CORTEX SCREWS 20MM, TWO (2) 2.4MM CORTEX 22MM, AND ONE (1) 2.4MM CORTEX 24MM. THE 2.4MM CORTEX SCREWS WOULD NOT FIT THROUGH THE GUIDE BLOCK FOR TWO-COLUMN PLATE 6 HOLE HEAD, GUIDE BLOCK FOR TWO-COLUMN PLATE 7 HOLE HEAD, NOR THE GUIDE BLOCK FOR TWO-COLUMN PLATE NARROW 6 HOLE. THE REST OF THE 2.4MM CORTEX SCREWS DID. THE ISSUE WAS FOUND IN STERILE PROCESSING DEPARTMENT (SPD). THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICES REPORTED: UNKNOWN CORTEX SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN) THIS COMPLAINT INVOLVES NINE (9) DEVICES. THIS IS 4 OF 9 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9244321 ↗
• MalfunctionMay 1, 2019Device-Device Incompatibility; Device-Device Incompatibility

  CONCOMITANT DEVICE REPORTED: GUIDE BLOCK FOR TWO-COLUMN PLATE (PART#03.111.701, LOT# UNKNOWN, QUANTITY#1) UNKNOWN PLATE ( PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8569078 ↗
• MalfunctionMay 1, 2019Device-Device Incompatibility; Device-Device Incompatibility

  CONCOMITANT DEVICE REPORTED: GUIDE BLOCK FOR TWO-COLUMN PLATE (PART#03.111.701, LOT# UNKNOWN, QUANTITY#1) UNKNOWN PLATE ( PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8569049 ↗
• MalfunctionMay 1, 2019Device-Device Incompatibility; Device-Device Incompatibility

  CONCOMITANT DEVICE REPORTED: GUIDE BLOCK FOR TWO-COLUMN PLATE (PART#03.111.701, LOT# UNKNOWN, QUANTITY#1) UNKNOWN PLATE ( PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8569033 ↗
• MalfunctionNov 28, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2018, DURING AN UNKNOWN SURGERY, THE SURGEON ATTEMPTED TO INSERT A CORTEX SCREW THROUGH A GUIDE BLOCK FOR TWO-COLUMN PLATE BUT THE SCREW WOULD NOT FIT THROUGH THE GUIDE BLOCK. THE OTHER 2.4 MM CORTEX SCREWS WERE USED SUCCESSFULLY. THE SURGICAL PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: GUIDE BLOCK FOR TWO-COLUMN PLATE (PART# 03.111.600, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 2.4MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 20MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8110099 ↗
• InjuryOct 19, 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. 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 WAS WITH THE ELBOW BEING FULLY SUPINATED OR AT LEAST IN NEUTRAL POSITION. WITHOUT REALIZING THIS, THE SURGEON PROCEEDED TO STABILIZE IT FULLY WITH COMBINATION OF THREE (3) NONLOCKING SCREW

  Patient problems: No Code Available

  MAUDE report 7986675 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K002271, K063049, K102694, K103243, K112583. One submission often covers many models, so check the product and lot details in each record.

• Z-0879-2020 · Dec 16, 2019 · Terminated
  2.4MM TI VA LOCKING SCREW STARDRIVE 10MM STERILE, Part Number 04.210.110TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the ste
• Z-0881-2020 · Dec 16, 2019 · Terminated
  2.4MM TI VA LOCKING SCREW STARDRIVE 16MM STERILE, Part Number 04.210.116TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the ste
• Z-0882-2020 · Dec 16, 2019 · Terminated
  2.4MM TI VA LOCKING SCREW STARDRIVE 18MM STERILE, Part Number 04.210.118TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the ste
• Z-0880-2020 · Dec 16, 2019 · Terminated
  2.4MM TI VA LOCKING SCREW STARDRIVE 12MM STERILE, Part Number 04.210.112TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the ste
• Z-0883-2020 · Dec 16, 2019 · Terminated
  2.4MM TI VA LOCKING SCREW STARDRIVE 24MM STERILE, Part Number 04.210.124TS - Product Usage:Sterile Tube Packaging is a packaging system to deliver single, sterile screws to the ste
• 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-0956-2013 · Jan 11, 2013 · Terminated
  Variable Angle Locking Compression Plate/VA-LCP Dorsal Distal Radius Plate, Part Number 02.115.431. Indicated for: Dorsally displaced fractures, Open joint reconstruction, and Cor