NA 04.211.018Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10886982119018), received between Jul 18, 2022 and Sep 22, 2026 — classified as 8 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Break; Entrapment of Device

  It was reported that on (b)(6) 2026, the patient underwent ORIF for a clavicle shaft fracture using the screw in question. The VACP was used for fixation. During screw insertion, excessive torque was continuously applied to the screw, resulting in screw fracture. The proximal one-third of the screw fractured, while the remaining distal two-thirds remained implanted in the patient. The surgery was completed successfully with the retained fragment left in the patient. According to the surgeon, the risk of screw fracture increased because the screw size had been reduced to 2.7 mm compared to the previous product.The surgery was completed successfully without any surgical delay.

  Patient problems: Foreign Body In Patient

  MAUDE report 50854670 ↗
• MalfunctionSep 1, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50544829 ↗
• InjuryJun 13, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT ORIF SURGERY FOR LEFT MIDSHAFT CLAVICLE FRACTURES WITH THE VA LOCKING SCREW AND A CLAVICLE PLATE AT DIFFERENT HOSPITAL. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. ON (B)(6) 2025, THE BREAKAGE OF THE VA LOCKING SCREW WAS CONFIRMED, AND THE REVISION SURGERY WAS SCHEDULED ON (B)(6) 2025. ALTHOUGH THE SURGERY WAS FOR A NONUNION, THE SURGEON OPINION WAS THAT THE SCREW BROKE BECAUSE THE PLATE WAS FIXED WITHOUT ANY TREATMENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information; Nonunion/Delayed-union Bone Fracture

  MAUDE report 22206326 ↗
• MalfunctionMar 4, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON DECEMBER 20, 2023, A FOREIGN OBJECT WAS FOUND IN THE STERILIZATION PACK. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L18 TAN THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18826444 ↗
• MalfunctionFeb 13, 2024Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN OSTEOSYNTHESIS WITH A VA LCP OLECRANON 4-HOLE PLATE. THE SCREW IN QUESTION WAS INSERTED IN VARIABLE ANGLE MODE, BUT FINAL TIGHTENING WITH TORQUE COULD NOT BE ACHIEVED. REPLACEMENT OF THE SCREW WAS NOT DONE AT THE SURGEON¿S DISCRETION. THE SURGEON COMPLETED THE TIGHTENING MANUALLY TO THE MAXIMUM EXTENT. FOR ALL OTHER SCREWS, THE FINAL TIGHTENING WAS SUCCESSFUL. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. PATIENT STATUS/ OUTCOME: STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L18 TAN THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18695192 ↗
• 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 L18 TAN THIS

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 18242804 ↗
• 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 L18 TAN. THIS IS

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 18240903 ↗
• MalfunctionOct 11, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT A SURGERY TREATING THE RIGHT CLAVICLE. THE SURGEON OPENED THE SCREW AND TRIED TO CONNECT THE SCREW HEAD TO A T8 SCREWDRIVER, BUT THE SCREW HEAD COULD NOT BE CONNECTED. THE SURGEON EXCHANGED THE SCREWDRIVER AND TRIED TO CONNECT THE SCREW TO THE NEW SCREWDRIVER, BUT HE COULDN¿T. THE SURGEON DID NOT USED THE SCREW IN QUESTION AT THE SURGEON¿S DISCRETION AND USED ANOTHER SCREW WITH THE SAME STANDARD. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. PATIENT STATUS/ OUTCOME: STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L18 TAN. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17912696 ↗
• MalfunctionSep 11, 2023Device-Device Incompatibility; Device-Device Incompatibility

  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 HUMERAL FRACTURE WITH THE LOCKING SCREW AND PLATE. DURING SCREW INSERTION, THE SCREWS DIDN¿T LOCK TO THE PLATE IN TWO HOLES (SECOND AND SIXTH HOLES FROM THE DISTAL HOLE). THE SURGEON USED A DRILL GUIDE AND DRILL, AND INSERTED THE SCREWS AFTER MEASURING. THAT TIME, TWO SCREWS WERE IDLE, AND THE SURGEON RE-DRILLED AND RE-INSERTED THE SCREWS. THE REINSERTED SCREWS WERE LOCKED TO THE PLATE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN A 30-MINUTE DELAY. THE PATIENT STATUS/OUTCOME WAS REPORTED TO BE STABLE. THIS REPORT INVOLVES ONE 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 18MMCLOSE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17720247 ↗
• MalfunctionMay 16, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. THE SURGEON DRILLED WITH A THREADED DRILL GUIDE AND INSERTED THE SCREW IN QUESTION, BUT THE SCREW WENT THROUGH THE SCREW HOLE ON A PLATE WITHOUT BEING LOCKED. THE SURGEON REPLACED THE SCREW WITH ANOTHER SCREW WITH THE SAME SIZE AND INSERTED IT TO THE SCREW HOLE ON THE PLATE. THAT SCREW WAS LOCKED SUCCESSFULLY AT THE SCREW HOLE ON THE PLATE AND INSERTED PROPERLY. THE SCREW IN QUESTION WAS DISCARDED AT THE HOSPITAL. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L18 TAN. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16939911 ↗
• MalfunctionMay 5, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT SURGERY WITH VA-CLAVICLE PLATE AND VA LOCKING SCREW. DURING INSERTION OF THE MEDIAL SCREW OF THE VA-CLAVICLE PLATE, AN EVENT OCCURRED. IN WHICH THE SCREW WAS DIFFICULT TO INSERT, PARTLY BECAUSE THE PATIENT HAD GOOD BONE QUALITY. AFTER 2.0 MM DRILLING, THE DIRECTION OF THE SCREW WAS CHECKED BY DEPTH GAUGE, AND INSERTION WAS ATTEMPTED. BUT THE SCREW COULD NOT BE INSERTED AT ALL. THE SURGEON SLIGHTLY WIDENED THE INSERTION OPENING WITH A HOSPITAL-OWNED 2.4 MM K-WIRE AND REINSERTED THE SCREW, WHICH INSERTED SMOOTHLY. AFTER THE SURGERY, THE SURGEON REQUESTED THAT A TAPPING SCREW BE NEEDED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. PATIENT IS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) VA LOCKSCR A, 2.7 HE 2.4 SELF-TAP L18 TAN. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16879450 ↗
• MalfunctionMay 5, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT SURGERY WITH VA-CLAVICLE PLATE AND VA LOCKING SCREW. DURING INSERTION OF THE MEDIAL SCREW OF THE VA-CLAVICLE PLATE, AN EVENT OCCURRED IN WHICH THE SCREW WAS DIFFICULT TO INSERT, PARTLY BECAUSE THE PATIENT HAD GOOD BONE QUALITY. AFTER 2.0 MM DRILLING, THE DIRECTION OF THE SCREW WAS CHECKED BY DEPTH GAUGE AND INSERTION WAS ATTEMPTED, BUT THE SCREW COULD NOT BE INSERTED AT ALL. THE SURGEON SLIGHTLY WIDENED THE INSERTION OPENING WITH A HOSPITAL-OWNED 2.4 MM K-WIRE AND REINSERTED THE SCREW, WHICH INSERTED SMOOTHLY. AFTER THE SURGERY, THE SURGEON REQUESTED THAT A TAPPING SCREW BE NEEDED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. PATIENT IS STABLE. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNK - DEPTH GAUGES: TRAUMA (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN) UNK - GUIDE/COMPRESSION/K-WIRES: TRAUMA(PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN) UNK - PLATES: TRAUMA (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN) THIS REPORT IS FOR ONE (1) VA LOCKS ø2.7 HE 2.4 SELF-TAP L18 TAN THIS IS REPORT 2 OF 4 FOR COMPLAIN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16879396 ↗
• MalfunctionMay 5, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT SURGERY WITH VA-CLAVICLE PLATE AND VA LOCKING SCREW. DURING INSERTION OF THE MEDIAL SCREW OF THE VA-CLAVICLE PLATE, AN EVENT OCCURRED IN WHICH THE SCREW WAS DIFFICULT TO INSERT, PARTLY BECAUSE THE PATIENT HAD GOOD BONE QUALITY. AFTER 2.0 MM DRILLING, THE DIRECTION OF THE SCREW WAS CHECKED BY DEPTH GAUGE AND INSERTION WAS ATTEMPTED, BUT THE SCREW COULD NOT BE INSERTED AT ALL. THE SURGEON SLIGHTLY WIDENED THE INSERTION OPENING WITH A HOSPITAL-OWNED 2.4 MM K-WIRE AND REINSERTED THE SCREW, WHICH INSERTED SMOOTHLY. AFTER THE SURGERY, THE SURGEON REQUESTED THAT A TAPPING SCREW BE NEEDED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. PATIENT IS STABLE NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNK - DEPTH GAUGES: TRAUMA (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). UNK - GUIDE/COMPRESSION/K-WIRES: TRAUMA(PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). UNK - PLATES: TRAUMA (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS REPORT IS FOR ONE (1) VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L18 TAN THIS IS REPORT 3 OF 4 FOR COMPL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16879370 ↗
• InjuryApr 5, 2023Break; Break

  DEVICE REPORT FROM SYNTHES 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 LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 18MM. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16682074 ↗
• InjuryFeb 21, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE 49-YEAR-OLD MALE PATIENT UNDERWENT THE UNKNOWN SURGERY FOR CLAVICLE TRUNK FRACTURE WITH VA CLAVICLE. THE FRACTURE SITE WAS SLIGHTLY DISTAL AND WAS A WEDGE-SHAPED FRACTURE WITH A RANGE OF 3 CM. THE FRACTURE WAS WRAPPED WITH THREAD, REPAIRED, AND FIXED WITH CS1 FOR THE DIAPHYSIS. POSTERIOR THERAPY WAS LIMITED TO 90° ABDUCTION ELEVATION. ON (B)(6) 2023, 9 DAYS AFTER SURGERY, THE MOST PROXIMAL SCREW WAS FOUND TO BE BROKEN OFF AT THE NECK. THE FRACTURE SITE APPEARS TO BE SLIGHTLY DISPLACED FROM THE INITIAL FIXATION DUE TO THE BREAKAGE OF ONE SCREW. BOTH DISTAL AND PROXIMAL ARE FIXED WITH FOUR VA2.7 LOCKING SCREWS EACH, BUT THE PROXIMAL ONE OR TWO APPEAR TO BE HANGING ON THE FRACTURE ON THE X-RAY, AND THE SURGEON WAS CONCERNED ABOUT IT. HIS COMMENT ON THE RELATIONSHIP BETWEEN THIS EVENT AND THE PRODUCT IS THAT THE MAJOR CAUSE OF THE BREAKAGE MAY BE THE LACK OF STRENGTH OF THE 2.7MM DIAMETER. HE CONSIDERED CHOOSING A PLATE ONE SIZE LONGER INTRAOPERATIVELY, BUT CHOSE CS1 BECAUSE THE PLATE DID NOT HIT WELL IN TEMPLATING. THE REOPERATION WAS NOT CONSIDERED AT THIS POINT. THE FRACTURE SIT

  Patient problems: Failure of Implant

  MAUDE report 16408507 ↗
• 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 15811346 ↗
• MalfunctionNov 16, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN 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 PSEUDORADICULAR 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 REP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15808757 ↗
• InjuryOct 19, 2022Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022 THE PATIENT UNDERWENT ORIF FOR CLAVICLE WITH THE PRODUCTS IN QUESTION. ON (B)(6) 2022, IT WAS FOUND THAT THE SCREW WAS BROKEN OFF AND ON (B)(6) 2022 THE PATIENT UNDERWENT REMOVAL SURGERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE PATIENT OUTCOME. IT WAS CONFIRMED WITH X-RAY IMAGING THAT NO FRAGMENTS REMAINED BEHIND IN THE BODY. THIS REPORT IS FOR A 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 18MM. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 15632021 ↗
• InjurySep 29, 2022Break; Break

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT ORIF FOR FRACTURE OF CLAVICLE SHAFT WITH THE SCREWS AND CLAVICLE PLATE IN QUESTION. DURING THE SURGERY, 3 LOCKING SCREWS AND 1 CORTEX SCREW WERE INSERTED AT THE PROXIMAL BONE FRAGMENT, AND 3 LOCKING SCREWS AND 1 CORTEX SCREW WERE INSERTED AT THE DISTAL BONE FRAGMENT. ON (B)(6) 2022 THE PATIENT VISITED THE HOSPITAL DUE TO PAIN, AND A REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2022. DURING THE REVISION PROCEDURE IT WAS CONFIRMED THAT THE 3 DISTAL SCREWS HAD BEEN DISLOCATED, AND THE 1 LOCKING SCREW HAD BEEN BROKEN AT ITS NECK. THE REVISION SURGERY WAS 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 18MM. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15502286 ↗
• InjuryAug 31, 2022Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY WITH THE IMPLANTS FOR RIGHT DISTAL CLAVICULAR FRACTURE. AFTER SURGERY, WHEN THE PATIENT LIFTED THE AFFECTED SIDE TO REACH FOR SOMETHING AT A HIGH PLACE, A CRACKLING NOISE WAS HEARD. CR IMAGING REVEALED THAT ALL 2.7 MM SCREWS INSERTED IN THE DISTAL PART OF THE FRACTURE WERE BROKEN JUST BELOW THE SCREWHEAD. ALL THE IMPLANTS WILL BE EXTRACTED AND REPLACED WITH A CLAVICLE HOOK PLATE IN A REVISION SURGERY. THE DATE OF THE REVISION SURGERY IS NOT DETERMINED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 18MM THIS IS REPORT 6 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Failure of Implant

  MAUDE report 15331866 ↗
• InjuryJul 18, 2022Migration; Migration

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION SURGERY FOR THE DISTAL CLAVICULAR OF RIGHT FRACTURE WITH THE PLATE AND SCREWS IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. ON (B)(6) 2022, SEVERAL MALFUNCTIONS WERE OBSERVED IN OUTPATIENT FOLLOW-UP EXAMINATION AS FOLLOWS. THE RIGHT CLAVICLE HAS OBVIOUS TENTING. IT WAS CONFIRMED BY COMPUTED RADIOGRAPHY (CR) IMAGE THAT TWO SCREWS INSERTED INTO THE DISTAL BONE FRAGMENT WERE BROKEN. THOSE LOT OR SIZE COULD NOT BE IDENTIFIED. TWO OTHER SCREWS INSERTED INTO THE DISTAL BONE HAS BACKED OUT. THE PLATE HAS BEEN DISLODGED. THE PATIENT HAS NO SUBJECTIVE SYMPTOM. A REVISION SURGERY WILL OCCUR BUT IT IS NOT KNOWN IF IT HAS BEEN COMPLETED. THIS IS REPORT 8 OF 9 FOR (B)(4). THIS REPORT IS FOR A LOCKING SCREW.

  Patient problems: Failure of Implant

  MAUDE report 15044274 ↗

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-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-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-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