NA 04.211.014Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10886982118998), received between Sep 27, 2022 and Aug 21, 2025 — classified as 8 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2025Defective Device; Defective Device

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT ORIF SURGERY FOR CLAVICLE FRACTURE. AFTER THE SURGERY, THE SALES REP WAS INFORMED BY THE DISTRIBUTOR THAT BURRS HAD APPEARED WHILE INSERTING THE SCREW IN QUESTION, SO A DIFFERENT PRODUCT HAD BEEN OPENED AND USED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22866478 ↗
• 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 22345999 ↗
• 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 22345980 ↗
• 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 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 22345900 ↗
• MalfunctionDec 12, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT FOREIGN-BODY REMOVAL TO REMOVE THE PLATE AND SCREW WITH THE PRODUCTS IN QUESTION. IN THE SURGERY, WHEN ATTEMPTING TO EXTRACT THE SCREW IN QUESTION WITH THE SCREWDRIVER IN QUESTION, THE HEAD OF THE SCREW BROKE OFF AND SEPARATED FROM THE SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20913167 ↗
• MalfunctionMar 6, 2024Break; Break

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH VACLP. AFTER THE ORIGINAL SURGERY, A REMOVAL SURGERY WAS PERFORMED. DURING THE REMOVAL SURGERY, THE 2ND SCREW FROM THE LATERAL BROKE OFF UNDERNEATH THE SCREW HEAD WHEN IT WAS TURNED WITH A SCREWDRIVER. THE BROKEN SCREW WAS REMOVED WITH A REMOVAL KIT. IT WAS CONFIRMED VIA X-RAY THAT THERE WERE NO PIECES LEFT IN THE PATIENT¿S BODY. NO FURTHER INFORMATION IS AVAILABLE. THE REMOVAL SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THIS REPORT IS FOR A 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 14MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18848228 ↗
• MalfunctionNov 30, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT A REMOVAL SURGERY. THE PRIMARY SURGERY WAS PERFORMED WITH THE CLAVICLE PLATE AND THE SCREWS FOR THE CLAVICLE DIAPHYSEAL FRACTURE ON (B)(6) 2022. WHEN THE PLATE WAS REMOVED, THE FOUR SCREWS BROKE UNDER THE SCREW HEADS. THE SURGEON TURNED THE SCREW HEAD TWICE TO REMOVE IT AND IT BROKE UNDER THE SCREW HEAD. ALTHOUGH THE SURGEON TRIED TO REMOVE THE BROKEN SCREWS WITH HOLLOW REAMER AND OTHER INSTRUMENTS, THEY COULD NOT BE REMOVED. THE FOUR SCREW SHAFTS REMAINED IN THE BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. PATIENT STATUS/ OUTCOME: PROGRESS IS UNDER OBSERVATION. ACCORDING TO THE SURGEON, POSSIBLE CAUSE OTHER THAN THE PRODUCT IS TOO MANY SCREWS AND THE SCREWS WERE FIXED TOO TIGHTLY. THE SURGEON ASKED THE FOLLOWING QUESTIONS. WHAT IS THE NUMBER OF CASES OF BROKEN SCREWS IN RELATION TO THE NUMBER OF VA CLAVICLE PLATES USED IN JAPAN? WHICH HAS MORE CASES OF BROKEN SCREWS, CORTEX SCREWS OR LOCKING SCREWS? HOW MANY CASES OF EACH? NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L14 TAN. THIS IS

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 18240904 ↗
• MalfunctionNov 30, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT A REMOVAL SURGERY. THE PRIMARY SURGERY WAS PERFORMED WITH THE CLAVICLE PLATE AND THE SCREWS FOR THE CLAVICLE DIAPHYSEAL FRACTURE ON (B)(6) 2022. WHEN THE PLATE WAS REMOVED, THE FOUR SCREWS BROKE UNDER THE SCREW HEADS. THE SURGEON TURNED THE SCREW HEAD TWICE TO REMOVE IT AND IT BROKE UNDER THE SCREW HEAD. ALTHOUGH THE SURGEON TRIED TO REMOVE THE BROKEN SCREWS WITH HOLLOW REAMER AND OTHER INSTRUMENTS, THEY COULD NOT BE REMOVED. THE FOUR SCREW SHAFTS REMAINED IN THE BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. PATIENT STATUS/ OUTCOME: PROGRESS IS UNDER OBSERVATION. ACCORDING TO THE SURGEON, POSSIBLE CAUSE OTHER THAN THE PRODUCT IS TOO MANY SCREWS AND THE SCREWS WERE FIXED TOO TIGHTLY. THE SURGEON ASKED THE FOLLOWING QUESTIONS. -WHAT IS THE NUMBER OF CASES OF BROKEN SCREWS IN RELATION TO THE NUMBER OF VA CLAVICLE PLATES USED IN JAPAN? -WHICH HAS MORE CASES OF BROKEN SCREWS, CORTEX SCREWS OR LOCKING SCREWS? HOW MANY CASES OF EACH? NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L14 TAN THIS I

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 18240899 ↗
• InjuryAug 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN OSTEOSYNTHESIS WITH A VA-LCP VOLAR RIM DRP (04.115.751S) FOR FRACTURE OF THE LEFT DISTAL RADIUS. IN THE SURGERY, THE VA-LCP DHP IN QUESTION (04.117.508S) WAS ALSO APPLIED TO THE DORSAL SIDE FOR JOINT FIXATION. APPROXIMATELY 3 MONTHS AFTER SURGERY, BONE UNION WAS CONFIRMED, AND REMOVAL OF THE IMPLANTS WAS SCHEDULED. AFTER THAT, INFECTION OF THE DORSAL SIDE AND LOOSENING OF THE SCREW WAS OBSERVED AT THE TIME OF X-RAYS TAKEN APPROXIMATELY 2 WEEKS AGO. ON (B)(6), A REMOVAL SURGERY WAS PERFORMED. THE PALMAR VA-LCP VOLAR RIM DRP WAS SUCCESSFULLY REMOVED, AND BONE UNION WAS OBSERVED TO BE ACHIEVED WITHOUT PROBLEMS. DORSAL SIDE WAS INFECTED, AND THE LOCKING SCREW WAS LOOSENING. NONE OF THE PLATES AND SCREWS WERE DIFFICULT TO REMOVE, AND ALL THE PLATES AND SCREWS COULD BE REMOVED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 14MM. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: Skin Inflammation/ Irritation; Unspecified Infection

  MAUDE report 17452638 ↗
• 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 PSEUDO ARTHROPLASTY 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 AUGUST 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 IMPLANT

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

  MAUDE report 15811766 ↗
• InjuryNov 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) 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 IMPLANT

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

  MAUDE report 15811446 ↗
• InjuryNov 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) 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 IMPLANT

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

  MAUDE report 15811300 ↗
• InjuryNov 16, 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 15811264 ↗
• MalfunctionNov 16, 2022Break; Break

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN (B)(4) AS FOLLOWS: THIS PC REPORTS THE SCREW BREAKAGE. 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 PSEUDOARTICULAR SURGERY WITH THE PRODUCTS IN QUESTION BECAUSE SHE WAS CONCERNED ABOUT THE PROTRUSION OF HER COLLARBONE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. 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. REGARDING THE CAUSE OF THE BREAKAGE, THE SURGEON COMMENTED THAT THE IMPLANT MUST HAVE BEEN SUBJECTED TO A CONSIDERABLE BOUNCE LOAD AFTER PLATE FIXATION BECAUSE THE BONE FRAGMENTS WERE ORIGINALLY DISPLACED SIGNIFICANTLY IN THE POST-CONSERVATIVE TREATMENT PSEUDOARTHROSIS. THE SURGEON ALSO COMMENTED THAT SIMILAR EVENTS WOULD LIKELY HAVE OCCURRED EVEN WITHOUT THIS PLATE, AS OTHER COMPANIES OFTEN USE NEARLY EQUIVALENT SCREW DIAMETERS. PATIENT STATUS/ OUTCOME: STABLE NO FURTHER INFORMATION IS AVAILABLE. THIS RE

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15809934 ↗
• InjuryNov 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) 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 IMPLANT

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

  MAUDE report 15809901 ↗
• InjurySep 27, 2022Use of Device Problem; Use of Device Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT SURGERY FOR A FRACTURE OF ELBOW BONE HEAD WITH THE PLATE AND SCREWS IN QUESTION. ON AN UNKNOWN DATE, THE FIXATION WAS LOST. ON (B)(6) 2022, A REVISION SURGERY WAS PERFORMED AND COMPLETED SUCCESSFULLY WITH A NEW PLATE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 14MM. THIS IS REPORT 3 OF 10 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15490657 ↗
• InjurySep 27, 2022Use of Device Problem; Use of Device Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT SURGERY FOR A FRACTURE OF ELBOW BONE HEAD WITH THE PLATE AND SCREWS IN QUESTION. ON AN UNKNOWN DATE, THE FIXATION WAS LOST. ON (B)(6) 2022, A REVISION SURGERY WAS PERFORMED AND COMPLETED SUCCESSFULLY WITH A NEW PLATE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 14MM. THIS IS REPORT 4 OF 10 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 15490652 ↗

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-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-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-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-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