NA 02.211.018Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10886982053602), received between Dec 12, 2017 and Dec 14, 2023 — classified as 10 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (5 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.

• MalfunctionDec 14, 2023Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT ON NOVEMBER 22, 2023, THE PACKAGE THAT WAS SUPPOSED TO CONTAIN A SCREW WAS DELIVERED SEALED AND EMPTY. ALL CONTENTS WERE RECEIVED BUT ONE OF THE PACKETS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 18MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18329109 ↗
• 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 13 OF 17 FOR PC-(B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 14090666 ↗
• MalfunctionJun 30, 2021Material Twisted/Bent; Material Twisted/Bent

  THE ISSUE WAS DISCOVERED DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12094165 ↗
• MalfunctionJun 30, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, SCREW HEADS WERE STRIPPED OUT AND WOULD NOT RETAIN THE SCREWDRIVER AND THUS NOT ALLOWING THEM TO BE INSERTED. IT IS UNKNOWN IF THERE IS SURGICAL DELAY REPORTED AND IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 18. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12094152 ↗
• 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 18. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11792631 ↗
• MalfunctionAug 5, 2020Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE REPORTER PLACED AN ORDER AND WHEN RECEIVED AT THE HOSPITAL TO RESTOCK THE TRAY, THERE WAS NO PRODUCT IN THE PACKAGE OF THE VARIABLE ANGLE (VA) LOCKING SCREW, THOUGH THE PACKAGE WAS FULLY SEALED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 18MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10367853 ↗
• MalfunctionDec 3, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) PROCEDURE OF THE OLECRANON, A VARIABLE ANGLE (VA) LOCKING SCREW DID NOT LOCK INTO THE UNKNOWN PLATE. THERE WAS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9403720 ↗
• MalfunctionOct 17, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, TWO (2) OF THE VARIABLE ANGLE (VA) DISTAL LOCKING SCREWS DID NOT LOCK INTO THE VARIABLE ANGLE - LOCKING COMPRESSION PLATE (VA-LCP) DURING AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF THE ANKLE. THE SCREWS WERE LEFT IN PLACE AND THERE IS NO PLAN FOR REVISION. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT OUTCOME. THIS REPORT IS FOR ONE (1) 2.7 MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 18 MM. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9204126 ↗
• MalfunctionOct 11, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNKNOWN ORTHOPEDIC PROCEDURE, THREE (3) VARIABLE ANGLE (VA) LOCKING SCREWS WOULD NOT LOCK INTO FOUR DIFFERENT SCREW HOLES OF THE VA LOCKING COMPRESSION PLATE (LCP) OLECRANON PLATE. THERE WAS A SURGICAL DELAY OF 30 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 18MM. THIS IS REPORT 4 OF 4 FOR REPORT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9178966 ↗
• MalfunctionJun 5, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, THREE (3) LOCKING SCREWS WERE NOT LOCKING IN. THE VARIABLE ANGLE DISTAL FIBULA PLATE WAS ALSO USED. THERE WAS A SURGICAL DELAY OF TWENTY (20) MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE SCREWS STILL IMPLANTED IN THE PATIENT. CONCOMITANT DEVICES REPORTED: 2.7MM VA-LCP LATERAL DISTAL FIBULA PLATE/6 HOLES/LEFT (PART# 02.118.407, LOT# UNKNOWN, QUANTITY# 1. THIS IS REPORT 1 OF 3 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN LOCKING SCREW.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8670528 ↗
• MalfunctionFeb 26, 2019Device-Device Incompatibility; Device-Device Incompatibility

  CONCOMITANT DEVICES REPORTED: 1.8MM DRILL BIT (PART # (B)(4), LOT UNKNOWN, QUANTITY 1), VARIABLE ANGLE GUIDE (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8371386 ↗
• 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 8115521 ↗
• InjuryNov 6, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT THE REMOVAL OF A VARIABLE ANGLE (VA) LOCKING SCREW, VA LOCKING COMPRESSION PLATE (LCP) LATERAL DISTAL FIBULAR PLATE, AND UNKNOWN SCREWS ON (B)(6) 2018. DURING THE REMOVAL PROCEDURE, THE HEAD OF A VA LOCKING SCREW BROKE OFF. THE REMOVAL PROCEDURE IS ADDRESSED IN THIS REPORT. (B)(4) ADDRESSES THE INTRAOPERATIVE ISSUE WITH THE BROKEN SCREW HEAD. THIS REPORT IS FOR ONE (1) 2.7MM VA LOCKING SCREW. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Discomfort; No Code Available; Pain

  MAUDE report 8041378 ↗
• MalfunctionOct 31, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018 DURING REMOVAL OF VARIABLE ANGLE LOCKING COMPRESSION PLATE LATERAL DISTAL FIBULAR PLATE, THE SCREW HEAD OF VARIABLE ANGLE LOCKING SCREW BROKE OFF DURING ANKLE RECONSTRUCTION. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT AND PROCEDURE OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN PLATE ( PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8026487 ↗
• 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 5 OF 8 FOR (B)(4).

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7924056 ↗
• 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 4 OF 8 FOR (B)(4).

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7924045 ↗
• 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 2 OF 8 FOR (B)(4).

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7924041 ↗
• 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 1 OF 8 FOR (B)(4).

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7924037 ↗
• InjuryMar 30, 2018Break; Break

  IT WAS REPORTED THAT IN (B)(6) 2017 THE SURGEON PERFORMED A METATARSOPHALANGEAL FUSION ON THE PATIENT. POST-OP, IN (B)(6) 2018, THE PATIENT COMPLAINED OF PAIN AT THE OPERATION SITE. THE PATIENT STATES THAT THE SITE HAD BEEN RUN OVER BY A PERSON IN A WHEELCHAIR. X-RAYS SHOWED TWO BROKEN SCREWS AND A PLATE LOOSENING. DURING A SCHEDULED REVISION SURGERY ON (B)(6) 2018, THE SURGEON REMOVED THE PLATE AND SCREWS. THE SURGEON DID NOT REMOVE THE PIECES OF THE BROKEN SCREWS FROM THE PATIENT AND THEY WERE LEFT IN THE PATIENT¿S FOOT. THE FUSION SITE WAS REFUSED WITH TWO STAPLES. THE PATIENT OUTCOME WAS GOOD WITH NO SURGERY DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICES REPORTED: 2.7 MM VA LOCKING SCREW 18 MM (PART 02.211.018, LOT UNKNOWN, QTY 1), 2.7 MM VA LOCKING SCREW 16 MM (PART 02.211.016, LOT UNKNOWN, QTY 1), 2.7 MM VA LOCKING SCREW 14 MM (PART 02.211.014, LOT UNKNOWN, QTY 1), 2.7 MM CORTEX SCREW (PART 202.820, LOT UNKNOWN, QTY 2), 2.4/2.7 VA-LCP FOREFOOT/MIDFOOT PLATING SYSTEM (PART 02.211.237, LOT 6613277, QTY 1). THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant; Pain

  MAUDE report 7384754 ↗
• InjuryMar 30, 2018Break; Break

  IT WAS REPORTED THAT IN (B)(6) 2017 THE SURGEON PERFORMED A METATARSOPHALANGEAL FUSION ON THE PATIENT. POST-OP, IN (B)(6) 2018, THE PATIENT COMPLAINED OF PAIN AT THE OPERATION SITE. THE PATIENT STATES THAT THE SITE HAD BEEN RUN OVER BY A PERSON IN A WHEELCHAIR. X-RAYS SHOWED TWO BROKEN SCREWS AND A PLATE LOOSENING. DURING A SCHEDULED REVISION SURGERY ON (B)(6) 2018, THE SURGEON REMOVED THE PLATE AND SCREWS. THE SURGEON DID NOT REMOVE THE PIECES OF THE BROKEN SCREWS FROM THE PATIENT AND THEY WERE LEFT IN THE PATIENT¿S FOOT. THE FUSION SITE WAS REFUSED WITH TWO STAPLES. THE PATIENT OUTCOME WAS GOOD WITH NO SURGERY DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICES REPORTED: 2.7MM VA LOCKING SCREW 18MM (PART 02.211.018, LOT UNKNOWN, QTY 1), 2.7MM VA LOCKING SCREW 16MM (PART 02.211.016, LOT UNKNOWN, QTY 1), 2.7MM VA LOCKING SCREW 14MM (PART 02.211.014, LOT UNKNOWN, QTY 1), 2.7MM CORTEX SCREW (PART 202.820, LOT UNKNOWN, QTY 2), 2.4/2.7 VA-LCP FOREFOOT/MIDFOOT PLATING SYSTEM (PART 02.211.237, LOT 6613277, QTY 1). THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant; Pain

  MAUDE report 7384753 ↗
• 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 18MM. THIS IS REPORT 5 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: Muscular Rigidity; No Code Available

  MAUDE report 7108534 ↗

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