NA 02.127.140Recalls & reported problems

Synthes GmbH · 3.5MM VARIABLE ANGLE LOCKING SCREW/SLF-TPNG/STRDRV/40MM · Class 2 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 9
Deaths reported: 0
Injuries reported: 9
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10886982043245), received between Oct 30, 2020 and Jan 26, 2023 — classified as 9 injuries.

The most frequently reported specific device problem is “Break” (5 reports).

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

Device problems

Break5
Adverse Event Without Identified Device or Use Problem4
No Apparent Adverse Event2

Patient problems

No Code Available5
Nonunion/Delayed-union Bone Fracture5
Deformity/ Disfigurement4
Malunion of Bone4
No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

InjuryJan 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2023, THERE WAS REMOVAL OF HARDWARE DUE TO MALUNION. A PREVIOUS SURGERY WAS DONE IN MEXICO, AND PATIENTS TIBIA HEALED IN EXTREME VARUS. A CORRECTION SURGERY WAS COMPLETED FOLLOWING THE HARDWARE REMOVAL. HARDWARE/EXPLANT REMOVAL WAS DUE TO EXTREME VARUS DEFORMITY. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR ONE (1) 3.5 VA LCKNG SCR SLF-TPNG/SD/40. THIS IS REPORT 6 OF 6 FOR COMPLAINT (B)(4).
Patient problems: Deformity/ Disfigurement; Malunion of Bone
MAUDE report 16251168 ↗
InjuryJan 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
T WAS REPORTED THAT ON (B)(6) 2023, THERE WAS REMOVAL OF HARDWARE DUE TO MALUNION. A PREVIOUS SURGERY WAS DONE IN MEXICO, AND PATIENTS TIBIA HEALED IN EXTREME VARUS. A CORRECTION SURGERY WAS COMPLETED FOLLOWING THE HARDWARE REMOVAL. HARDWARE/EXPLANT REMOVAL WAS DUE TO EXTREME VARUS DEFORMITY. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR ONE (1) 3.5 VA LCKNG SCR SLF-TPNG/SD/40. THIS IS REPORT 5 OF 6 FOR COMPLAINT (B)(4).
Patient problems: Deformity/ Disfigurement; Malunion of Bone
MAUDE report 16251164 ↗
InjuryJan 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2023, THERE WAS REMOVAL OF HARDWARE DUE TO MALUNION. A PREVIOUS SURGERY WAS DONE IN MEXICO, AND PATIENTS TIBIA HEALED IN EXTREME VARUS. A CORRECTION SURGERY WAS COMPLETED FOLLOWING THE HARDWARE REMOVAL. HARDWARE/EXPLANT REMOVAL WAS DUE TO EXTREME VARUS DEFORMITY. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR ONE (1) 3.5MM CORTEX SCREW SELF-TAPPING 30MM THIS IS REPORT 4 OF 6 FOR COMPLAINT (B)(4).
Patient problems: Deformity/ Disfigurement; Malunion of Bone
MAUDE report 16251163 ↗
InjuryJan 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT ON (B)(6) 2023, THERE WAS REMOVAL OF HARDWARE DUE TO MALUNION. A PREVIOUS SURGERY WAS DONE IN MEXICO, AND PATIENTS TIBIA HEALED IN EXTREME VARUS. A CORRECTION SURGERY WAS COMPLETED FOLLOWING THE HARDWARE REMOVAL. HARDWARE/EXPLANT REMOVAL WAS DUE TO EXTREME VARUS DEFORMITY. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR ONE (1) 3.5 VA LCKNG SCR SLF-TPNG/SD/40. THIS IS REPORT 2 OF 6 FOR COMPLAINT (B)(4).
Patient problems: Deformity/ Disfigurement; Malunion of Bone
MAUDE report 16251132 ↗
InjuryOct 30, 2020Break; Break
IT WAS CLARIFIED THAT FOUR (4) VARIABLE LOCKING SCREWS AND THREE (3) CORTEX SCREWS WERE REMOVED BUT NOT BROKEN. THREE (3) OF THE LOCKING SCREWS WERE BROKEN. TWO (2) OF THE BROKEN SCREWS WERE REMOVED; ONE (1) BROKEN SCREW AND THE 3.5 ANTEROLATERAL RIGHT 15-HOLE PLATE WERE LEFT IN THE PATIENT. UPDATED CONCOMITANT DEVICES: LCP ANTEROLATERAL DISTAL TIBIAL PLATE (PART 241.45, LOT UNKNOWN, QUANTITY 1); CORTEX SCREW, SELF-TAPPING, L40MM (PART 204.84, LOT UNKNOWN, QUANTITY 3); VA LOCKING SCREW, SELF-TAPPING, L40MM (PART 02.127.140, LOT UNKNOWN, QUANTITY 2). THIS IS REPORT 2 OF 3 FOR (B)(4).
Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture
MAUDE report 10763920 ↗
InjuryOct 30, 2020Break; Break
IT WAS CLARIFIED THAT FOUR (4) VARIABLE LOCKING SCREWS AND THREE (3) CORTEX SCREWS WERE REMOVED BUT NOT BROKEN. THREE (3) OF THE LOCKING SCREWS WERE BROKEN. TWO (2) OF THE BROKEN SCREWS WERE REMOVED; ONE (1) BROKEN SCREW AND THE 3.5 ANTEROLATERAL RIGHT 15-HOLE PLATE WERE LEFT IN THE PATIENT. UPDATED CONCOMITANT DEVICES: LCP ANTEROLATERAL DISTAL TIBIAL PLATE (PART 241.45, LOT UNKNOWN, QUANTITY 1); CORTEX SCREW, SELF-TAPPING, L40MM (PART 204.84, LOT UNKNOWN, QUANTITY 3); VA LOCKING SCREW, SELF-TAPPING, L40MM (PART 02.127.140, LOT UNKNOWN, QUANTITY 2).
Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture
MAUDE report 10763806 ↗
InjuryOct 30, 2020Break; No Apparent Adverse Event; Break; No Apparent Adverse Event
IT WAS CLARIFIED THAT FOUR (4) VARIABLE LOCKING SCREWS AND THREE (3) CORTEX SCREWS WERE REMOVED BUT NOT BROKEN. THREE (3) OF THE LOCKING SCREWS WERE BROKEN. TWO (2) OF THE BROKEN SCREWS WERE REMOVED; ONE (1) BROKEN SCREW AND THE 3.5 ANTEROLATERAL RIGHT 15-HOLE PLATE WERE LEFT IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Code Available; Nonunion/Delayed-union Bone Fracture
MAUDE report 10763763 ↗
InjuryOct 30, 2020Break; No Apparent Adverse Event; Break; No Apparent Adverse Event
IT WAS CLARIFIED THAT FOUR (4) VARIABLE LOCKING SCREWS AND THREE (3) CORTEX SCREWS WERE REMOVED BUT NOT BROKEN. THREE (3) OF THE LOCKING SCREWS WERE BROKEN. TWO (2) OF THE BROKEN SCREWS WERE REMOVED; ONE (1) BROKEN SCREW AND THE 3.5 ANTEROLATERAL RIGHT 15-HOLE PLATE WERE LEFT IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Code Available; Nonunion/Delayed-union Bone Fracture
MAUDE report 10763498 ↗
InjuryOct 30, 2020Break; Break
IT WAS CLARIFIED THAT FOUR (4) VARIABLE LOCKING SCREWS AND THREE (3) CORTEX SCREWS WERE REMOVED BUT NOT BROKEN. THREE (3) OF THE LOCKING SCREWS WERE BROKEN. TWO (2) OF THE BROKEN SCREWS WERE REMOVED; ONE (1) BROKEN SCREW AND THE 3.5 ANTEROLATERAL RIGHT 15-HOLE PLATE WERE LEFT IN THE PATIENT. UPDATED CONCOMITANT DEVICES: LCP ANTEROLATERAL DISTAL TIBIAL PLATE (PART: 241.45, LOT: UNKNOWN, QUANTITY 1); CORTEX SCREW, SELF-TAPPING, L40MM (PART: 204.84, LOT: UNKNOWN, QUANTITY 3); VA LOCKING SCREW, SELF-TAPPING, L40MM (PART: 02.127.140, LOT: UNKNOWN, QUANTITY 2) THIS IS REPORT 1 OF 3 FOR (B)(4).
Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture
MAUDE report 10763313 ↗

Device details

UDI-DI	`10886982043245`
Brand	NA
Model	02.127.140
Catalog no.	02127140
Company	Synthes GmbH
Product code	HRS · PLATE, FIXATION, BONE
Class	Class 2
FDA submission	K120689, K120854, K121601
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Feb 6, 2025

Device type (GMDN): Orthopaedic bone screw (non-sliding)

A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.

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Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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