NA 04.211.016Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10886982119001), received between Jul 18, 2022 and Mar 24, 2026 — classified as 21 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Break” (22 reports).

7 other recalls cover devices cleared under the same FDA submission (K100776, K103243); 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 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 24, 2026Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT NO SCREW WAS PRESENT INSIDE THE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24679925 ↗
• MalfunctionMar 24, 2026Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT NO SCREW WAS PRESENT INSIDE THE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24673504 ↗
• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: NO INFORMATION PROVIDED. DATE OF EVENT: 3 DEC 2025 DATE OF IMPLANT: (B)(6) 2025 DEVICE LOCATION: LEFT. ¿ POSTOPERATIVE ADVERSE EVENT: "PAIN/DISCOMFORT/PROMINENCE" ¿ IS THE AE RELATED TO THE IMPLANTATION OR EXPLANTATION OF THE HOOK PLATE? "POSSIBLE" ¿ IS THE AE RELATED TO THE INVESTIGATIONAL DEVICE (VA CLAVICLE PLATE/VA CLAVICLE HOOK PLATE)? " POSSIBLE" ¿ IS THE AE RELATED TO THE CONDITION UNDER INVESTIGATION? ¿POSSIBLE¿ ¿ DPS IMPLANT WAS USED. DEVICE RELATED: POSSIBLE PROCEDURE RELATED: POSSIBLE DEVICE LOCATION: LEFT. TREATMENT: IMPLANT REMOVAL, THE EVENT RESULTED IN A MEDICAL OR SURGICAL INTERVENTION TO PREVENT LIFE THREATENING ILLNESS OR INJURY OR PERMANENT IMPAIRMENT TO A BODY STRUCTURE OR A BODY FUNCTION. DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 04.112.814S LOT NUMBER: NO INFORMATION PROVIDED COMPONENT TYPE: PLATE DESCRIPTION: 2.7MM TI VA LCP HOOK PLATE LONG/ 15MM/ LEFT/ STERILE. CATALOG NUMBER: 04.211.014TS LOT NUMBER: NO INFORMATION AVAILABLE COMPONENT TYPE: SCREW DESCRIPTION: VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L14 TAN. CATALOG NUMBER: 04.211.014TS LOT NUMBER: NO INFORMATION AVAILABLE COMPONENT TYPE: SCREW DESCRIPTION: VA LOCKSCR ø2.7 HE 2.4 S

  Patient problems: Discomfort; Pain; Skin Inflammation/ Irritation

  MAUDE report 24388614 ↗
• InjuryJul 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY FOR DISTAL CLAVICLE FRACTURE WITH THE PLATE AND THE SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. ON (B)(6) 2025, THE SALES REP VISITED THE HOSPITAL AFTER BEING INFORMED BY THE DISTRIBUTOR THAT THE PLATE WOULD BE REMOVED AND REPLACED WITH A VA CLAVICLE PLATE. AFTER LOOKING AT THE X-RAY, THE SALES REP CONFIRMED THAT THE FRACTURE WAS NEAR THE MOST PROXIMAL PLATE. THE SURGEON'S OPINION WAS THAT THE MOST PROXIMAL SCREW AND THE SCREW NEXT TO IT WERE INSERTED SO THAT THEY CONVERGED, WHICH CAUSED STRESS TO CONCENTRATE AND LEAD TO A SECONDARY FRACTURE. AFTER REMOVING THE PRODUCT, THE PATIENT WILL BE REFIXED WITH A VA CLAVICLE PLATE. THE DOCTOR'S OPINION ON THE RELATIONSHIP BETWEEN THIS INCIDENT AND THE PRODUCT: THE MOST PROXIMAL SCREW AND THE SECOND ROW OF VA 2.7 (04.211.016TS) WERE INSERTED SO THAT THEY CONVERGED, WHICH CAUSED STRESS TO CONCENTRATE AND LEAD TO A SECONDARY FRACTURE. PATIENT IS STABLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 22637419 ↗
• InjuryJul 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY FOR DISTAL CLAVICLE FRACTURE WITH THE PLATE AND THE SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. ON (B)(6) 2025, THE SALES REP VISITED THE HOSPITAL AFTER BEING INFORMED BY THE DISTRIBUTOR THAT THE PLATE WOULD BE REMOVED AND REPLACED WITH A VA CLAVICLE PLATE. AFTER LOOKING AT THE X-RAY, THE SALES REP CONFIRMED THAT THE FRACTURE WAS NEAR THE MOST PROXIMAL PLATE. THE SURGEON'S OPINION WAS THAT THE MOST PROXIMAL SCREW AND THE SCREW NEXT TO IT WERE INSERTED SO THAT THEY CONVERGED, WHICH CAUSED STRESS TO CONCENTRATE AND LEAD TO A SECONDARY FRACTURE. AFTER REMOVING THE PRODUCT, THE PATIENT WILL BE REFIXED WITH A VA CLAVICLE PLATE. THE DOCTOR'S OPINION ON THE RELATIONSHIP BETWEEN THIS INCIDENT AND THE PRODUCT: THE MOST PROXIMAL SCREW AND THE SECOND ROW OF VA 2.7 (04.211.016TS) WERE INSERTED SO THAT THEY CONVERGED, WHICH CAUSED STRESS TO CONCENTRATE AND LEAD TO A SECONDARY FRACTURE. PATIENT IS STABLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 22629590 ↗
• InjuryJul 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY FOR DISTAL CLAVICLE FRACTURE WITH THE PLATE AND THE SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. ON (B)(6) 2025, THE SALES REP VISITED THE HOSPITAL AFTER BEING INFORMED BY THE DISTRIBUTOR THAT THE PLATE WOULD BE REMOVED AND REPLACED WITH A VA CLAVICLE PLATE. AFTER LOOKING AT THE X-RAY, THE SALES REP CONFIRMED THAT THE FRACTURE WAS NEAR THE MOST PROXIMAL PLATE. THE SURGEON'S OPINION WAS THAT THE MOST PROXIMAL SCREW AND THE SCREW NEXT TO IT WERE INSERTED SO THAT THEY CONVERGED, WHICH CAUSED STRESS TO CONCENTRATE AND LEAD TO A SECONDARY FRACTURE. AFTER REMOVING THE PRODUCT, THE PATIENT WILL BE REFIXED WITH A VA CLAVICLE PLATE. THE DOCTOR'S OPINION ON THE RELATIONSHIP BETWEEN THIS INCIDENT AND THE PRODUCT: THE MOST PROXIMAL SCREW AND THE SECOND ROW OF VA 2.7(04.211.016TS) WERE INSERTED SO THAT THEY CONVERGED, WHICH CAUSED STRESS TO CONCENTRATE AND LEAD TO A SECONDARY FRACTURE. PATIENT IS STABLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 22629381 ↗
• MalfunctionJun 27, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY FOR MIDSHAFT CLAVICLE FRACTURE WITH THE VACP CS1. ON JUN 9, 2025, THE SALES REP GOT AN INFORMATION THAT THE SCREWS BROKE AT THE REMOVAL SURGERY. WHEN THE SURGEON TURNED THE SCREWDRIVER TO REMOVE THE SCREWS, IT BROKE AT THE SCREW HEAD. USING PLIERS ETC., THEY WERE ALL REMOVED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22346199 ↗
• MalfunctionJun 27, 2025Break; Break

  IT WAS REPORTED THAT ON FEB 6, 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY FOR MIDSHAFT CLAVICLE FRACTURE WITH THE VACP CS1. ON JUN 9, 2025, THE SALES REP GOT AN INFORMATION THAT THE SCREWS BROKE AT THE REMOVAL SURGERY. WHEN THE SURGEON TURNED THE SCREWDRIVER TO REMOVE THE SCREWS, IT BROKE AT THE SCREW HEAD. USING PLIERS ETC., THEY WERE ALL REMOVED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22346046 ↗
• MalfunctionJun 27, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY FOR MIDSHAFT CLAVICLE FRACTURE WITH THE VACP CS1. ON (B)(6) 2025, THE SALES REP GOT AN INFORMATION THAT THE SCREWS BROKE AT THE REMOVAL SURGERY. WHEN THE SURGEON TURNED THE SCREWDRIVER TO REMOVE THE SCREWS, IT BROKE AT THE SCREW HEAD. USING PLIERS ETC., THEY WERE ALL REMOVED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22346036 ↗
• MalfunctionJun 27, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY FOR MIDSHAFT CLAVICLE FRACTURE WITH THE VACP CS1. ON JUN 9, 2025, THE SALES REP GOT AN INFORMATION THAT THE SCREWS BROKE AT THE REMOVAL SURGERY. WHEN THE SURGEON TURNED THE SCREWDRIVER TO REMOVE THE SCREWS, IT BROKE AT THE SCREW HEAD. USING PLIERS ETC., THEY WERE ALL REMOVED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 22346020 ↗
• MalfunctionNov 14, 2024Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE PRODUCTS IN QUESTION. BECAUSE OF THE OUT OF STOCK, THERE WERE ONLY THREE 16MM SCREWS FROM THE SET, WHEREAS EIGHT SHOULD HAVE BEEN INCLUDED IN THE ORIGINAL SET. DIFFERENT SIZE SCREWS WERE USED FOR THE FOURTH AND SUBSEQUENT SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20684609 ↗
• MalfunctionJun 17, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY TREATING THE HUMERUS. THE SURGEON INSERTED THE SCREW INTO THE MOST DISTAL HOLE OF THE PLATE, BUT TORQUE COULD NOT BE APPLIED, AND THE SCREW IDLED. THE SURGEON REMOVED THE SCREW ONCE, CHECKED THE INSERTION ANGLE, AND REINSERTED THE SCREW, BUT THE TORQUE COULD NOT BE APPLIED TO THE SCREW. THE SCREW WAS LEFT IN THE BODY AT THE SURGEON¿S DISCRETION BECAUSE IT DIDN¿T SEEM TO COME OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. PATIENT WAS STABLE. THIS REPORT IS FOR A 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 16MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19554124 ↗
• MalfunctionMay 15, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT ORIF WITH A VA-DHP PLATE FOR DISTAL HUMERUS FRACTURE. IN THE PROCESS OF DRILLING WITH SHARP OR WIDE ANGLE TO MOST DISTAL SCREW HOLE ON THE PLATE, DRILLING AND AIMED SCREW WERE BEING AIR, THE TORQUE WORKED POORLY, THEREFORE, METAL GRINDED OBJECTS WERE NOTICED. ONCE THEY WERE TAKEN OUT, WITHOUT WIDE ANGLE CONDITION, DRILLING TO THE SAME HOLE, THE MOST DISTAL SCREW ONE, WAS PERFORMED AS RETRY FOR INSERTION, AS A RESULT, THE TORQUE WELL-WORKED. INTRA-OP IMAGE INTENSIFIER CONFIRMED THERE IS NO THE REMAINDERS IN THE PATIENT¿S BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L16 TAN THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19321892 ↗
• MalfunctionMay 7, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY TREATING HUMERUS. WHEN A MEDIAL PLATE WAS INSTALLED, THREE (3) OUT OF FIVE (5) SCREWS WERE NOT LOCKED AND BECAME IDLED. ONE OF THE IDLED SCREWS WAS REPLACED WITH ANOTHER SCREW, AND THAT SCREW WAS ABLE TO BE APPLIED TORQUE. THEREFORE, TWO (2) IDLED SCREWS WERE USED AS THEY WERE AND LEFT IN THE PATIENT¿S BODY. SINCE A POSTERIOR LATERAL PLATE WAS ALSO USED, THE ASSISTING SURGEON DETERMINED THAT THERE WAS NO PROBLEM WITH FIXATION, AND THE SURGERY WAS COMPLETED. EXTENDED SURGICAL TIME WAS LESS THAN THIRTY (30) MINUTES. THIS REPORT IS FOR A SCREW. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19258437 ↗
• MalfunctionApr 18, 2024Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2024, WHEN SCREWING THE SCREW INTO THE BONE, THE SCREW HEAD BROKE OFF. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THE FRAGMENTS WERE REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION. THIS REPORT INVOLVES ONE 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 16MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19138425 ↗
• InjuryDec 26, 2023Break; Break

  THIS REPORT IS FOR ONE (1) 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 12MM.

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 18394884 ↗
• MalfunctionSep 11, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE PRODUCTS IN QUESTION. ON AN UNKNOWN DATE, THE OLECRANON IMPLANTS WERE REMOVED AS BONE FUSION WAS ACHIEVED. DURING THE PROCEDURE, IT WAS FOUND THAT TWO OF THE SCREWS WERE DIFFICULT TO REMOVE. ONE OF THE SCREWS BROKE IMMEDIATELY UPON TURNING THE SCREW. THE OTHER SCREW BROKE WHEN THE ENTIRE PLATE WAS BEING TURNED WHILE ATTEMPTING TO REMOVE THE SCREW. PATIENT OUTCOME IS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 16MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17718725 ↗
• MalfunctionJul 31, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  THE EVENT WAS IDENTIFIED IN THE LOCAL DISTRIBUTOR'S FACILITY, THEREFORE, NO PATIENT WAS INVOLVED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17427247 ↗
• MalfunctionApr 25, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT OPEN REDUCTION/INTERNAL FIXATION SURGERY FOR A RIGHT CLAVICLE FRACTURE WITH THE VA-LCP PLATE IN QUESTION. THE FRACTURE SITE WAS MAINTAINED IN REDUCED POSITION BY INSERTING A LAG SCREW AND FURTHER FIXED WITH CS2 DIAPHYSEAL PLATE. THEN, THE LOCKING SCREW IN QUESTION WAS INSERTED, BUT METAL FRAGMENTS WERE GENERATED AT THAT TIME. BOTH THE SCREW AND PLATE WERE IMPLANTED IN THE PATIENT, AND ONLY THE METAL PIECES WERE COLLECTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE PATIENT STATUS WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 16MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16809246 ↗
• InjuryApr 5, 2023Break; Break

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT THE OPEN REDUCTION AND INTERNAL FIXATION (ORIF) SURGERY FOR CLAVICULAR DIAPHYSEAL FRACTURE WITH VA-CP DIAPHYSIS CS2 IMPLANTS. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER 6 WEEKS, ON (B)(6) 2023, OF NON-WEIGHT BEARING, AT THE MOMENT WHEN THE PATIENT TRIED TO LIFT THE ARM FOR THE FIRST TIME, 3 LOCKING SCREWS 2.7 MM IN QUESTION ON THE PROXIMAL SIDE WERE BROKEN, AND 1 CORTICAL SCREW IN QUESTION CAME OFF. REVISION SURGERY WAS DONE ON (B)(6) 2023, WITH OUR ANTERIA CLAVICLE IMPLANTS. THE REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE SURGEON COMMENTED THAT WHEN USING THE 3.5 MM PLATE OF THE PAST STANDARD, THE SCREW DID NOT BREAK EVEN IF THE REDUCTION POSITION WAS SOMEWHAT POOR, BUT THIS TIME THE SCREW BROKE BECAUSE THE NEW PRODUCT STANDARD WAS SMALLER, AND THE STRENGTH WAS WEAKER. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 2.7MM TI VA LACKING SCR SELF-TAPING WITH T8 STARDRIVE RECESS 16MM. THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16682076 ↗
• InjuryApr 5, 2023Break; Break

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT THE OPEN REDUCTION AND INTERNAL FIXATION (ORIF) SURGERY FOR CLAVICULAR DIAPHYSEAL FRACTURE WITH VA-CP DIAPHYSIS CS2 IMPLANTS. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER 6 WEEKS, ON (B)(6) 2023, OF NON-WEIGHT BEARING, AT THE MOMENT WHEN THE PATIENT TRIED TO LIFT THE ARM FOR THE FIRST TIME, 3 LOCKING SCREWS 2.7 MM IN QUESTION ON THE PROXIMAL SIDE WERE BROKEN, AND 1 CORTICAL SCREW IN QUESTION CAME OFF. REVISION SURGERY WAS DONE ON (B)(6) 2023, WITH OUR ANTERIA CLAVICLE IMPLANTS. THE REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. THE SURGEON COMMENTED THAT WHEN USING THE 3.5 MM PLATE OF THE PAST STANDARD, THE SCREW DID NOT BREAK EVEN IF THE REDUCTION POSITION WAS SOMEWHAT POOR, BUT THIS TIME THE SCREW BROKE BECAUSE THE NEW PRODUCT STANDARD WAS SMALLER, AND THE STRENGTH WAS WEAKER. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 2.7MM TI VA LACKING SCR SELF-TAPNG WITH T8 STARDIVE RECESS 16MM. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16682073 ↗
• MalfunctionJan 4, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION WITH THE VA LOCKING SCREWS IN QUESTION FOR THE OLECRANON FRACTURE. WHEN THE VA LOCKING SCREW WAS INSERTED INTO THE MOST PROXIMAL HOLE, THE SCREW WOULD NOT TIGHTEN AND IDLED. THEREFORE, A NEW SCREW WAS USED. HOWEVER, THIS NEW SCREW WOULD NOT TIGHTEN AND IDLED AS WELL. THE SURGEON DETERMINED THAT SUFFICIENT LOCKING SCREWS HAVE BEEN INSERTED IN OTHER HOLES. THE SURGEON CONSIDERED POSTOPERATIVE BACK-OUT AND DECIDED TO REMOVE THE SCREWS IN QUESTION. THE CAUSE OF THE EVENT IS UNKNOWN. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 16MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16094694 ↗
• MalfunctionJan 4, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION WITH THE VA LOCKING SCREWS IN QUESTION FOR THE OLECRANON FRACTURE. WHEN THE VA LOCKING SCREW WAS INSERTED INTO THE MOST PROXIMAL HOLE, THE SCREW WOULD NOT TIGHTEN AND IDLED. THEREFORE, A NEW SCREW WAS USED. HOWEVER, THIS NEW SCREW WOULD NOT TIGHTEN AND IDLED AS WELL. THE SURGEON DETERMINED THAT SUFFICIENT LOCKING SCREWS HAVE BEEN INSERTED IN OTHER HOLES. THE SURGEON CONSIDERED POSTOPERATIVE BACK-OUT AND DECIDED TO REMOVE THE SCREWS IN QUESTION. THE CAUSE OF THE EVENT IS UNKNOWN. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 16MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16094690 ↗
• MalfunctionNov 17, 2022Break; Break

  THIS PC IS RELATED TO (B)(4) WHICH REPORTS PAIN AND DEVICE EXPLANTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15815945 ↗
• InjuryNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: THIS PC IS RELATED TO (B)(4) WHICH REPORTS THE SCREW BREAKAGE . THIS PC REPORTS THE PAIN. IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT HAD AN INJURY TO THE CLAVICLE, AND AFTER CONSERVATIVE TREATMENT, PSEUDOARTHROSIS DEVELOPED. ON (B)(6) 2022, THE PATIENT UNDERWENT THE CLAVICLE FRACTURE PSEUDOARTHROPLASTY WITH THE PRODUCTS IN QUESTION BECAUSE SHE WAS CONCERNED ABOUT THE PROTRUSION OF HER COLLARBONE. DURING AN OUTPATIENT VISIT ON (B)(6) 2022, THE PATIENT WAS OBSERVED TO HAVE 5 DISTAL SCREW FRACTURES. SINCE THERE WERE NO COMPLAINTS OF PAIN AT THIS POINT, THE PATIENT WAS DECIDED TO BE FOLLOWED UP. IN LATE (B)(6) 2022, THE PATIENT COMPLAINS OF PAIN AND THE IMPLANTS WERE DETERMINED TO BE REMOVED. ON (B)(6) 2022, THE IMPLANTS WERE REMOVED. IT WAS OBSERVED THAT FIVE DISTAL SCREWS BROKEN OFF AT THE BASE OF THE HEAD. THE SCREW SHAFT PORTION APPEARED TO PROTRUDE OUTSIDE THE BONE ON THE X-RAY, BUT AFTER THE PLATE WAS REMOVED, THE SCREW SHAFT PORTION COULD NOT BE SEEN DUE TO SCARRING. THE SURGEON USED A HALO REAMER TO CUT THE BONE IN THE FRONT AND THEN USED RADIO PLIERS AND SCREW GRASPING FORCEPS TO SAFELY REMOVE THE IMPLANTS

  Patient problems: Nonunion/Delayed-union Bone Fracture; Pain

  MAUDE report 15814978 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K100776, K103243. One submission often covers many models, so check the product and lot details in each record.

• 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-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-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-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-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-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