NA 02.211.020Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10886982053619), received between Dec 12, 2017 and Jan 2, 2024 — classified as 14 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (3 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 16, 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.

• MalfunctionJan 2, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN UNKNOWN PROCEDURE WHEN USING A PLATE OUT OF THE 2.7 MIDFOOT FOREFOOT SET THE SURGEON WAS PUTTING IN THE FINAL LOCKING SCREW AND THE SCREW WENT THROUGH THE PLATE. THEY USED THE PROPER DRILL BIT AND THEY ALSO USED A 2.7 VA LOCKING SCREW. LOCKING SCREW WAS REMOVED AND REPLACED WITH A CORTEX SCREW FOR A LARGER HEAD. SURGERY WAS COMPLETED WITHOUT ANY SURGICAL DELAY. THIS REPORT IS FOR A VA-LOCKING SCREW. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18424546 ↗
• InjuryNov 30, 2023Migration; Migration

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023 THE PATIENT UNDERWENT REVISION SURGERY. THE PLATE AND SCREWS IN QUESTION WERE REMOVED, SCREWS HAVE BACKED OUT OF THE PLATE AND SKIN. THE REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 20MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18242592 ↗
• InjuryNov 30, 2023Migration; Migration

  DEVICE REPORT FROM AUSTRALIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6)2023 THE PATIENT UNDERWENT REVISION SURGERY. THE PLATE AND SCREWS IN QUESTION WERE REMOVED, SCREWS HAVE BACKED OUT OF THE PLATE AND SKIN. THE REVISION PROCEDURE WAS COMPLETED SUCCESSFULLY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 20MM. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18239475 ↗
• MalfunctionNov 14, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: IT WAS REPORTED THAT USING A 2.7 LOCKING SCREW DID NOT ENGAGE PLATE THREADS, HENCE NOT LIMITING OFF. CURRENTLY, HEAD PROTRUSIONS ARE CAUSING IRRITATION. HAS BEEN PLACED IN CAST FOR LONGER THAN USUAL GIVEN THE LACK OF LOCKED CONSTRUCT. THE SURGEON IS PLANNING TO REMOVE OR REVISE THE CONSTRUCT DUE TO THE PATIENT¿S REPORTED IRRITATION. THE SURGEON WILL REMOVE THE PLATE ONCE HEALING CAN BE CONFIRMED. PATIENT STATUS/OUTCOME/ CONSEQUENCES: YES, REDUCE CONSTRUCT STRENGTH. THIS REPORT IS FOR ONE (1) UNK - SCREWS: LOCKING. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18129754 ↗
• MalfunctionFeb 28, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  DEVICE REPORT FROM BELGIUM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PRODUCT IN QUESTION WAS FOUND WITH EMPTY PACKAGING. THE EVENT OCCURRED PRE-OP, THERE WAS NO REPORTED PATIENT INTERACTION. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR A 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 20MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16452417 ↗
• MalfunctionOct 4, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, WHILE INSERTING A 2.7 VA LOCKING SCREW, A SCREW DID NOT PROPERLY ENGAGE INTO THE LOCKING HOLES OF A POSTERIOR MEDIAL DISTAL HUMERUS PLATE. ADDITIONALLY, WHEN INSERTING A LOCKING SCREW, A SHAVING OF METAL CAME OFF OF THE SCREW. IT WAS REMOVED AND THE SURGERY WAS SUCCESSFULLY COMPLETED. NO SURGICAL DELAY WAS REPORTED. THIS REPORT INVOLVES ONE 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 20MM. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15536131 ↗
• MalfunctionOct 4, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, WHILE INSERTING A 2.7 VA LOCKING SCREW, A SCREW DID NOT PROPERLY ENGAGE INTO THE LOCKING HOLES OF A POSTERIOR MEDIAL DISTAL HUMERUS PLATE. ADDITIONALLY, WHEN INSERTING A LOCKING SCREW, A SHAVING OF METAL CAME OFF OF THE SCREW. IT WAS REMOVED AND THE SURGERY WAS SUCCESSFULLY COMPLETED. NO SURGICAL DELAY WAS REPORTED. THIS REPORT INVOLVES ONE 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 20MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15536124 ↗
• InjuryApr 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2019, THE PATIENT WAS INVOLVED IN AN INCIDENT AT WORK THAT RESULTED IN MULTIPLE INJURIES, ONE OF WHICH WAS A FRACTURE TO HIS ARM. TO REPAIR THE FRACTURE, THE SURGEON PLACED AN IMPLANT IN THE PATIENT'S ARM. ON (B)(6) 2019, THE IMPLANT BROKE CAUSING ANOTHER FRACTURE TO THE PATIENT'S ARM. ON (B)(6), 2019, THE PATIENT UNDERWENT A REVISION PROCEDURE TO REMOVE THE BROKEN IMPLANT. THIS IS REPORT 2 OF 17 FOR PC-(B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 14089635 ↗
• InjuryNov 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, ON OR ABOUT (B)(6) 2019 THE PATIENT HAD OPEN REDUCTION ULNAR FRACTURE PROXIMAL END WITH INTERNAL FIXATION OF HIS RIGHT ELBOW. ON OR ABOUT (B)(6) 2020 PATIENT WAS ADMITTED AND HAD AN INCISION, DRAINAGE, AND TREATMENT FOR INFECTION FROM HIS SURGICAL SITE. ON OR ABOUT (B)(6) 2021, THE PATIENT'S INFECTED HARDWARE WAS REMOVED FROM HIS BODY. THIS REPORT IS FOR ONE (1) 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 20. THIS IS REPORT 8 OF 10 FOR COMPLAINT. PRODUCT COMPLAINT (B)(4).

  Patient problems: Post Operative Wound Infection

  MAUDE report 12860594 ↗
• MalfunctionMay 7, 2021Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, A PATIENT UNDERWENT THE REVISION PROCEDURE OF A TMT-1 DUE TO PSEUDARTHROSIS. INITIAL PROCEDURE WAS PERFORMED ON (B)(6) 2020 WITH ARTHRODESIS WITH 2.7MM VARIABLE ANGLE (VA) X-PLATE. POSTOPERATIVELY, ONE (1) 2.7MM VA LOCKING SCREW WAS ALSO BROKEN IN THE SHAFT OF THE SCREW. THE SCREW WAS PARTIALLY EXPLANTED DURING REVISION PROCEDURE. THE SCREW SHAFT REMAINED IN THE BONE, BASED ON SURGEONS DECISION NOT TO REMOVE THE BROKEN SHAFT. REVISION WAS SUCCESSFULLY COMPLETED WITHOUT ANY ISSUE. THERE WAS NO SURGICAL DELAY. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 20. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11792533 ↗
• InjuryJan 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL EVENT DESCRIPTION. LEGAL AND MEDICAL RECORDS RECEIVED. ON OR ABOUT (B)(6) 2019, PATIENT EXPERIENCED DISPLACEMENT, PAIN, STIFFNESS OF RIGHT ELBOW, DISPLACED FRACTURE RIGHT, REMOVAL OF RADIUS HEAD IMPLANT, REMOVAL OF HARDWARE OF THE OLECRANON AS WELL AS THE RADIAL HEAD, LYSIS OF ADHESION AND DEBRIDEMENT. PATIENT PRESENTS DUE TO CONTINUED STIFFNESS OF THE RIGHT ELBOW AND WORSENING RIGHT ELBOW PAIN. FEELS LIKE OCCUPATIONAL THERAPY WAS VIGOROUS AND CAUSE ELBOW PAIN TO OCCUR AFTER SURGERY WHICH NEVER RESOLVED. PRIOR TO THAT SESSION SHE REPORTS SHE HAD WRIST PAIN AND NUMBNESS WHICH THEN RADIATED INTO THE ELBOW. CT SCAN OF RIGHT ELBOW WAS DONE FOR REVIEW. REPORTS OCCASIONAL NUMBNESS IN THE FINGER. ALSO HAS PERSISTENT NECK PAIN AND STIFFNESS. THE PATIENT PRESENTS WITH COMPLAINTS OF GRADUAL ONSET. THIS COMPLAINT INVOLVES (1) DEVICE RELATED PRODUCT COMPLAINT: (B)(4).

  Patient problems: Bone Fracture(s); Muscular Rigidity; Pain

  MAUDE report 11252495 ↗
• InjuryJan 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A RIGHT RADIAL HEAD REVISION RECONSTRUCTION, REMOVAL OF HARDWARE OF THE OLECRANON AS WELL AS THE RADIAL HEAD, LYSIS OF ADHESION AND DEBRIDEMENT AND WAS IMPLANTED WITH A NON-SYNTHES DEVICE DUE TO A RIGHT ELBOW RADIAL HEAD REPLACEMENT FAILURE, SYMPTOMATIC HARDWARE WITH STIFFNESS AND INCREASING PAIN. ON (B)(6) 2015, THE PATIENT HAS PRESENTED DISCOMFORT WITH PAIN OVER THE RIGHT ELBOW WHICH RADIATES TO THE RIGHT ELBOW. THE PATIENT FELL DOWN ON HER ELBOW AND SUSTAINED A FRACTURE DISLOCATION. SHE ALSO HAD NERVE SYMPTOMS MOSTLY IN THE ULNAR DISTRIBUTION. ON (B)(6) 2015, THE PATIENT UNDERWENT A RIGHT OLECRANON OPEN REDUCTION INTERNAL FIXATION, RADIAL HEAD RESECTION WITH RADIAL HEAD REPLACEMENT AND OPEN REDUCTION OF RADIAL HEAD AND WAS IMPLANTED WITH DEPUY SYNTHES 20MM DIAMETER HEAD AND A 4 HOLE LONG RIGHT OLECRANON PLATE. THE PATIENT WAS DIAGNOSED WITH RIGHT ELBOW FRACTURE-DISLOCATION, RADIAL HEAD OLECRANON COMMINUTED FRACTURE AND ULNAR NEURAPRAXIA. ON (B)(6) 2016, CT RIGHT UPPER EXTREMITY SHOWS PLATE AND SCREW FIXATION OF THE PROXIMAL ULNA. COMMINUTED INTRA-ARTICULAR FRACTURE NOW WITH BRIDGING CALLUS FORMATION. BRIDGING CALLUS FORM

  Patient problems: Bone Fracture(s); Muscular Rigidity; Pain

  MAUDE report 11251798 ↗
• InjuryAug 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION WITH PLATES AND SCREWS AND COMPRESSION DUE TO NONUNION LEFT PROXIMAL ULNA S/P ORIF MONTEGGIA FRACTURE SUBLUXATION. ON (B)(6) 2017, THE PATIENT UNDERWENT AN OPEN REDUCTION AND INTERNAL FIXATION OF THE COMMINUTED LEFT PROXIMAL ULNA AND WHERE A SYNTHES DEVICE WAS IMPLANTED. PRIOR TO THE REPORTED EVENT, THE PATIENT TRIPPED OVER A CURB AND FELL HER ON HER LEFT UPPER EXTREMITY RESULTING TO AN IMMEDIATE SEVERE PAIN. CONCOMITANT DEVICES REPORTED: 2.0MM CORTEX SCREW SLF-TPNG WITH STARDRIVE RECESS 24MM (PART NUMBER 201.374.97, LOT UNKNOWN, QUANTITY 1), 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 18MM (PART NUMBER 212.105, LOT UNKNOWN, QUANTITY 1), 2.7MM/3.5MM VA-LCP OLECRANON PL 4H/LT/116MM (PART NUMBER 02.107.304, LOT UNKNOWN, QUANTITY 1), 2.7MM METAPHYSEAL SCR SLF-TPNG W/T8 STRDRV RECESS/28MM (PART NUMBER 02.118.528, LOT UNKNOWN, QUANTITY 1), 2.7MM METAPHYSEAL SCR SLF-TPNG W/T8 STRDRV RECESS/34MM (PART NUMBER 02.118.534, LOT UNKNOWN, QUANTITY 1), 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 20MM (PART NUMBER 02.211.020, LOT UNKNOWN, QUANTITY 1), 2.7MM VA LCKNG SCREW SLF-TPNG WITH T

  Patient problems: Bone Fracture(s); No Code Available; Pain

  MAUDE report 10444635 ↗
• InjuryAug 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2017, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION WITH PLATES AND SCREWS AND COMPRESSION DUE TO NONUNION LEFT PROXIMAL ULNA S/P ORIF MONTEGGIA FRACTURE SUBLUXATION. ON (B)(6) 2017, THE PATIENT UNDERWENT AN OPEN REDUCTION AND INTERNAL FIXATION OF THE COMMINUTED LEFT PROXIMAL ULNA AND WHERE A SYNTHES DEVICE WAS IMPLANTED. PRIOR TO THE REPORTED EVENT, THE PATIENT TRIPPED OVER A CURB AND FELL HER ON HER LEFT UPPER EXTREMITY RESULTING TO AN IMMEDIATE SEVERE PAIN. CONCOMITANT DEVICES REPORTED: 2.0MM CORTEX SCREW SLF-TPNG WITH STARDRIVE RECESS 24MM (PART NUMBER 201.374.97, LOT UNKNOWN, QUANTITY 1), 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 18MM (PART NUMBER 212.105, LOT UNKNOWN, QUANTITY 1), 2.7MM/3.5MM VA-LCP OLECRANON PL 4H/LT/116MM (PART NUMBER 02.107.304, LOT UNKNOWN, QUANTITY 1), 2.7MM METAPHYSEAL SCR SLF-TPNG W/T8 STRDRV RECESS/28MM (PART NUMBER 02.118.528, LOT UNKNOWN, QUANTITY 1), 2.7MM METAPHYSEAL SCR SLF-TPNG W/T8 STRDRV RECESS/34MM (PART NUMBER 02.118.534, LOT UNKNOWN, QUANTITY 1), 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 20MM (PART NUMBER 02.211.020, LOT UNKNOWN, QUANTITY 1), 2.7MM VA LCKNG SCREW SLF-TPNG WITH T

  Patient problems: Bone Fracture(s); No Code Available; Pain

  MAUDE report 10444578 ↗
• InjuryAug 15, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2013, THE PATIENT UNDERWENT FUSION SURGERY ON THE FOOT AND WAS IMPLANTED WITH ONE (1) VARIABLE ANGLE- LOCKING COMPRESSION PLATE (VA-LCP) CLOVERLEAF FUSION PLATE, ONE (1) VA-LCP T-FUSION PLATE 2 HOLE HEAD, ONE(1) 4.0MM CANNULATED SCREW LONG THREAD, ONE (1) VA LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 26MM, ONE (1) VA LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 28MM, ONE (1) VA LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 14MM, ONE (1) VA LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 20MM, ONE (1) VA LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 24MM, ONE (1) VA LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 32MM, AND ONE (1) WASHER. IN LATE 2015, THE PATIENT BEGAN TO EXPERIENCE DISCOMFORT AND PAIN WHICH ATTRIBUTED TO HIS OSTEOARTHRITIS AND PREVIOUS FRACTURE. ON (B)(6) 2016, THE PAIN HAD WORSENED. X-RAYS OF THE FOOT WERE TAKEN WHICH SHOWED SEVERAL OF THE UNKNOWN SYNTHES SCREWS IMPLANTED WERE BROKEN. THE PATIENT¿S CLINIC VISITS ON (B)(6) 2016 AND (B)(6) 2017 WERE DUE TO THE PAIN FELT IN THE RIGHT ANKLE. THE PATIENT MET WITH ANOTHER SURGEON FOR A POSSIBLE REVISION, BUT THE SURGEON REFUSED TO PERFORM DUE TO THE RIS

  Patient problems: Loss of Range of Motion; No Code Available; Pain

  MAUDE report 8898755 ↗
• InjuryJun 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2015, THE PATIENT UNDERWENT A REMOVAL PROCEDURE OF PAINFUL HARDWARE PROXIMAL ASPECT OF RIGHT ULNA. ON (B)(6) 2014, THE PATIENT SUSTAINED AN INJURY AFTER TRIPPING AND FALLING FROM A STANDING POSITION AND LANDED DIRECTLY INTO THE RIGHT ELBOW. THE PATIENT HAD THE ONSET OF PAIN AND INABILITY TO FULLY USE THE ELBOW. SUBSEQUENT X-RAYS WERE TAKEN AND REVEALED A DISPLACED, DISTRACTED OLECRANON FRACTURE, WITH A COMMINUTED RIGHT RADIAL HEAD FRACTURE. THE PATIENT ALSO COMPLAINS OF PAIN IN THE RIGHT PROXIMAL HUMERUS. THE PATIENT WAS ORIGINALLY IMPLANTED ON (B)(6) 2014 WITH ONE (1) VARIABLE ANGLE ¿ LOCKING COMPRESSION PLATE (VA-LCP) PROXIMAL, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 14MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 16MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 20MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 24MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 30MM, ONE (1) VARIABLE ANGLE LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 40MM, ONE (1) LOCKING SCREW SELF-TAPPING WITH STARD

  Patient problems: Bone Fracture(s); Loss of Range of Motion; No Code Available; Pain

  MAUDE report 8692285 ↗
• InjuryNov 29, 2018Device Slipped; Device Slipped

  IT WAS NOTED THAT AT THE TIME OF THE REVISION PROCEDURE, THE CLAVICLE FRACTURE WAS NOT HEALED.

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 8115819 ↗
• InjuryOct 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A HARDWARE REMOVAL ON (B)(6) 2018 DUE TO A DRAINING WOUND. IT IS UNKNOWN WHEN THE DEVICES WERE IMPLANTED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT AND SURGICAL OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES EIGHT (8) DEVICES. THIS IS REPORT 7 OF 8 FOR (B)(4).

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7924072 ↗
• InjuryOct 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A HARDWARE REMOVAL ON (B)(6) 2018 DUE TO A DRAINING WOUND. IT IS UNKNOWN WHEN THE DEVICES WERE IMPLANTED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT AND SURGICAL OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES EIGHT (8) DEVICES. THIS IS REPORT 6 OF 8 FOR (B)(4).

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7924068 ↗
• MalfunctionJul 10, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2018. THE 2.7 VARIABLE ANGLE (VA) LOCKING SCREW DID NOT LOCK INTO THE SYNTHES 2.7/3.5 VARIABLE ANGLE LATERAL DISTAL HUMERUS PLATE. THE PLATE WAS IMPLANTED AND THE SCREW WAS DISCARDED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, WITH NO SURGICAL DELAY. THERE WAS NO REPORTED PATIENT CONSEQUENCE. THIS REPORT IS FOR A 2.7MM VA LOCKING SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 20MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7674529 ↗
• InjuryDec 12, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF RIGHT PROXIMAL ULNA ON (B)(6) 2017. AFTER THAT THE PATIENT COMPLAINED OF STIFFNESS AND SO THE SURGEON HAD TO DO THE REVISION SURGERY FOR REMOVAL OF THE PLATE AND SCREWS. THE PLATE AND THE SCREWS WERE INTACT AND THERE WAS NO MALFUNCTION WITH THE DEVICE. THE REVISION SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. THE PATIENT WAS STABLE AFTER THE SURGERY. THIS REPORT IS FOR ONE (1) 2.7MM VA LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 20MM. (B)(4).

  Patient problems: Muscular Rigidity; No Code Available

  MAUDE report 7108496 ↗

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-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-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-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-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