NA 02.211.010Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886982053541), received between Jul 3, 2018 and May 26, 2025 — classified as 6 injuries, 6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THREE (3) VA PATELLA SCREWS DID NOT LOCK. THERE WAS NO SURGICAL DELAY OR PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22084642 ↗
• MalfunctionMay 26, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THREE (3) VA PATELLA SCREWS DID NOT LOCK. THERE WAS NO SURGICAL DELAY OR PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22084636 ↗
• MalfunctionMay 23, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE VA LOCKING SCREW DID NOT LOCK IN. THERE WAS NO SURGICAL DELAY OR PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077716 ↗
• MalfunctionNov 20, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, AN ORIF ANKLE WAS PERFORMED AT HOSPITAL AS THE PLATE FAILED TO LOCK WITH THE SCREWS IN THE ANKLE SURGERY. STAFF TRIED MULTIPLE DIFFERENT SCREWS, DRILLED ON ANGLE & VA, TRIED A DIFFERENT PLATE, YET THE LOCKING SCREWS WOULD NOT LOCK INTO THE DISTAL CLUSTER. DUE TO THE PLATE NOT LOCKING, IT CAUSED UNNECESSARY DRILLING OF BONE AND ELONGATED TIME UNDER ANESTHESIA. THERE WAS A SURGICAL DELAY OF 1 HOUR. SURGEON SWAPPED THE PLATE OUT FOR FUNCTIONAL HARDWARE, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20732772 ↗
• MalfunctionNov 13, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, ORIF ANKLE WAS PERFORMED AT HOSPITAL AS THE PLATE FAILED TO LOCK WITH THE SCREWS IN THE ANKLE SURGERY. STAFF TRIED MULTIPLE DIFFERENT SCREWS, DRILLED ON ANGLE & VA, TRIED A DIFFERENT PLATE, YET THE LOCKING SCREWS WOULD NOT LOCK INTO THE DISTAL CLUSTER. DUE TO THE PLATE NOT LOCKING, IT CAUSED UNNECESSARY DRILLING OF BONE AND ELONGATED TIME UNDER ANESTHESIA. THERE WAS A SURGICAL DELAY OF 1 HOUR. SURGEON SWAPPED THE PLATE OUT FOR FUNCTIONAL HARDWARE. THERE WAS NO PATIENT STATUS/ OUTCOME / CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20675296 ↗
• InjuryMar 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, THE PATIENT UNDERWENT REVISION DUE TO SWELLLING, INFECTION(SEPSIS), PAIN AND IMPLANT FAILURE. XRAY AND ULTRASOUND CONFIRMED THAT THE HARDWARE IN HIS ANKLE HAS FAILED. THE PATIENT IS CURRENTLY TAKING BOTH ORAL AND IV ANTIBIOTICS. ON (B)(6) 2021 THE PATIENT WAS IMPLANTED WITH SYNTHES DEVICES ON LEFT ANKLE AFTER FALLING FROM A TREE. THIS REPORT IS FOR ONE (1)2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 10 THIS IS REPORT 8 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 16572169 ↗
• InjuryMar 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, THE PATIENT UNDERWENT REVISION DUE TO SWELLLING, INFECTION(SEPSIS), PAIN AND IMPLANT FAILURE. XRAY AND ULTRASOUND CONFIRMED THAT THE HARDWARE IN HIS ANKLE HAS FAILED. THE PATIENT IS CURRENTLY TAKING BOTH ORAL AND IV ANTIBIOTICS. ON (B)(6) 2021 THE PATIENT WAS IMPLANTED WITH SYNTHES DEVICES ON LEFT ANKLE AFTER FALLING FROM A TREE. THIS REPORT IS FOR ONE (1)2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 10. THIS IS REPORT 7 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 16572166 ↗
• InjuryMar 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, THE PATIENT UNDERWENT REVISION DUE TO SWELLING, INFECTION(SEPSIS), PAIN AND IMPLANT FAILURE. XRAY AND ULTRASOUND CONFIRMED THAT THE HARDWARE IN HIS ANKLE HAS FAILED. THE PATIENT IS CURRENTLY TAKING BOTH ORAL AND IV ANTIBIOTICS. ON (B)(6) 2021 THE PATIENT WAS IMPLANTED WITH SYNTHES DEVICES ON LEFT ANKLE AFTER FALLING FROM A TREE. THIS REPORT IS FOR ONE (1) 2.7 VA LCKNG SCR SLF-TPNG T8 SD REC 10. THIS IS REPORT 3 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: Pain; Swelling/ Edema; Unspecified Infection

  MAUDE report 16568753 ↗
• InjuryJan 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY TO IMPLANT THE DEVICES IN 2016. THE PATIENT FOUND OUT THAT THERE WAS A PROBLEM WITH THE IMPLANTS APPROXIMATELY 2 MONTHS AGO WHEN HE WENT TO THE EMERGENCY ROOM BECAUSE HIS ARM WAS BAD, AND X-RAYS WERE TAKEN. THE PATIENT UNDERWENT REVISION SURGERY TO REMOVE THE HARDWARE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 2.7MM VA LCKNG SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 10MM. THIS IS REPORT 8 OF 8 FOR (B)(4).

  Patient problems: Failure of Implant

  MAUDE report 16113698 ↗
• InjuryApr 1, 2020Adverse 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 OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF SUPRACONDYLAR-INTERCONDYLAR FRACTURE OF THE LEFT DISTAL HUMERUS AND ANTERIOR SUBCUTANEOUS TRANSPOSITION OF THE ULNAR NERVE DUE TO COMMINUTED SUPRACONDYLAR-INTERCONDYLAR FRACTURE OF THE LEFT DISTAL HUMERUS. DURING A MRI OF THE SPINE, THE PATIENT HAD SEVERE PAIN IN HER ELBOW. SHE FOUND OUT FROM THE SURGEON THAT DURING THE SURGERY TO REPAIR HER HUMERUS A DRILL BIT BROKE AND THE FRAGMENT WAS NOT REMOVED. IT WAS MORE BENEFICIAL TO LEAVE THE ITEM IMPLANTED RATHER THAN TAKING IT OUT. THE PHYSICIAN ADVISED THE PATIENT THAT TO REMOVED IT MAY CAUSE HER MORE HARM TO THE ITEM WAS LEFT IN. THIS IS REPORT 2 OF 3 FOR (B)(4). THIS PC IS LINKED TO (B)(4).

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 9910419 ↗
• InjuryApr 1, 2020Adverse 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 OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF SUPRACONDYLAR-INTERCONDYLAR FRACTURE OF THE LEFT DISTAL HUMERUS AND ANTERIOR SUBCUTANEOUS TRANSPOSITION OF THE ULNAR NERVE DUE TO COMMINUTED SUPRACONDYLAR-INTERCONDYLAR FRACTURE OF THE LEFT DISTAL HUMERUS. DURING A MRI OF THE SPINE, THE PATIENT HAD SEVERE PAIN IN HER ELBOW. SHE FOUND OUT FROM THE SURGEON THAT DURING THE SURGERY TO REPAIR HER HUMERUS A DRILL BIT BROKE AND THE FRAGMENT WAS NOT REMOVED. IT WAS MORE BENEFICIAL TO LEAVE THE ITEM IMPLANTED RATHER THAN TAKING IT OUT. THE PHYSICIAN ADVISED THE PATIENT THAT TO REMOVED IT MAY CAUSE HER MORE HARM TO THE ITEM WAS LEFT IN. (B)(4).

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 9910350 ↗
• MalfunctionJul 3, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) LEFT DISTAL HUMERUS FRACTURE ON (B)(6) 2018. DURING THE PROCEDURE, THE MEASUREMENT OF THE DEPTH GAUGE FOR SCREWS WAS 5MM WHICH WAS TOO SHORT. A SECOND SET WAS OPENED FOR ANOTHER DEPTH GAUGE AND THE SURGEON EXPRESSED THE SAME PROBLEM WITH THE SECOND ONE. IT WAS ALSO REPORTED THAT THE THREE (3) VARIABLE ANGLE (VA) LOCKING SCREWS WERE WASTED. ALL THREE SCREWS WERE REMEASURED TO CONFIRM LENGTH. THE VA LOCKING SCREW WOULD NOT LOCK INTO THE MOST DISTAL-LATERAL HOLE OF THE PLATE. THE SURGEON TRIED TO REMOVE IT BUT THE SCREW JUST SPUN IN THE LOCKING HOLE WITHOUT RETRACTING OUT. THE SURGEON CONTINUED TO IMPLANT THE PLATE BECAUSE THE REDUCTION AND THE REST OF THE FIXATION WERE GOOD. THE SCREW WAS ALSO REMAINED IMPLANTED BECAUSE IT WOULD NOT GET OUT WITHOUT TAKING THE PLATE OFF. THERE WERE 5-10 MINUTES OF SURGICAL DELAY. THE PATIENT OUTCOME WAS STABLE. CONCOMITANT DEVICES REPORTED: UNKNOWN VARIABLE ANGLE LOCKING SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 3) THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7658623 ↗

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-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-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-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