NA 202.220Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10886982144010), received between Apr 16, 2018 and Aug 19, 2022 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Twisted/Bent” (1 report).

6 other recalls cover devices cleared under the same FDA submission (K033995, K050110, K063049, K111540, K113364); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2022Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED DURING AN UNKNOWN PROCEDURE ON (B)(6) , 2022, THE DRILL BIT BROKE IN THE MIDDLE OF THE DRILL. SEVERAL SCREW HEADS APPEARED TO HAVE A BAD HEAD AND WERE NOT USED IN SURGERY. SURGERY WAS SUCCESSFULLY COMPLETED. PATIENT STATUS WAS NOTED AS OK. THIS IS REPORT 2 OF 11 FOR (B)(4). THIS REPORT IS FOR A DRILL BIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15259211 ↗
• InjuryJan 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2018, PATIENT HAD UNDERGONE AN ORTHOPEDIC REMOVAL PROCEDURE DUE TO PAIN. ORIGINAL DATE OF IMPLANT WAS ON (B)(6) 2012 FOR AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE LEFT ELBOW. IT WAS NOTED THAT FRACTURE HAD ALREADY HEALED. DEVICES INVOLVED WERE ONE (1) 3.5 MM CORTEX SCREW 16MM, ONE (1) 3.5MM CORTEX SCREW 20MM, ONE (1) 3.5 MM CORTEX SCREW 24MM, ONE (1) 3.5MM CORTEX SCREW 26MM, ONE (1) VARIABLE ANGLE (VA)-LOCKING COMPRESSION PLATE (LCP) EXTENDED MEDIAL DISTAL HUMERUS PLATE, ONE (1) METAPHYSEAL SCREW, ONE (1) 2.7MM VA LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 50MM, TWO (2) 2.7MM VA LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 60MM, ONE (1) LCP POSTEROLATERAL DISTAL HEMERUS PLATE WITH LATERAL SUPPORT, ONE (1) 2.7MM LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 14MM, TWO (2) 2.7MM LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 16MM, ONE (1) 2.7MM LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 20MM, AND ONE (1) 2.7MM LOCKING SCREW SELF-TAPPING WITH T8 STARDRIVE RECESS 60MM. ALL IMPLANTS WERE REMOVED EXCEPT FOR FOUR (4) SCREWS AS THE HEADS OF THE SCREWS WERE BROKEN OFF. IT WAS NOT DETERMINED WHICH AMONG THE SCREWS WERE

  Patient problems: Pain

  MAUDE report 8245489 ↗
• InjuryAug 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON OR AROUND (B)(6) 2016 SURGEON PERFORMED A CORRECTION OF NON UNION OF LEFT SUPRACONDYLAR HUMERUS FRACTURE. DEPUY SYNTHES HARDWARE WAS EXPLANTED AND BONE GRAFT WAS IMPLANTED. SURGEON ALSO PERFORMED NEUROLYSIS OF THE LEFT ULNAR NERVE. DUE TO DATABASE LIMITATIONS, EIGHT (8) ADDITIONAL DEVICES ARE CAPTURED IN (B)(4). THIS REPORT ADDRESSES DEVICES IDENTIFIED IN ADDITIONAL INFORMATION RECEIVED ON AUGUST 1, 2018. THIS REPORT IS FOR ONE (1) 2.7MM LOCKING SCREW. THIS IS REPORT 4 OF 8 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7799592 ↗
• InjuryApr 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER QUALITY UNIT RECEIVED A USER FACILITY REPORT FORWARDED FROM HARDIN MEMORIAL HOSPITAL; THIS REPORT IS AGAINST USER FACILITY MEDWATCH REPORT # (B)(4). ONLY ADDITIONAL AND/OR CORRECTED INFORMATION WILL BE CONTAINED IN THIS REPORT. A COPY OF THE USER FACILITY EVENT REPORT IS ATTACHED. IT WAS REPORTED PATIENT UNDERWENT A PROCEDURE IN WHICH THE 2.7MM/3.5MM LOCKING COMPRESSION PLATE (LCP) POSTEROLATERAL DISTAL FIBULA PLATE AND THIRTEEN (13) SCREWS FOR A CLAVICLE FRACTURE ON (B)(6) 2017. ON UNKNOWN DATE PATIENT DEVELOPED AN INFECTION AT THE IMPLANT SITE. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE SURGEON REMOVED ELEVEN (11) OF THE SCREWS AND THE PLATE. IT IS UNKNOWN WHY TWO (2) OF THE SCREWS REMAIN IMPLANTED. SURGERY WAS COMPLETED. PATIENT STATUS REPORTED AS OKAY. THE PLATE AND NINE (9) SCREWS ARE CAPTURED ON (B)(4). THIS REPORT CAPTURES THE REMAINING FOUR (4) SCREWS. THIS REPORT IS FOR ONE (1) 2.7MM LOCKING SCREW 20MM THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7434834 ↗
• InjuryApr 16, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER QUALITY UNIT RECEIVED A USER FACILITY REPORT FORWARDED FROM (B)(6) HOSPITAL; THIS REPORT IS AGAINST USER FACILITY MEDWATCH REPORT (B)(4). ONLY ADDITIONAL AND/OR CORRECTED INFORMATION WILL BE CONTAINED IN THIS REPORT. IT WAS REPORTED PATIENT UNDERWENT A PROCEDURE IN WHICH THE 2.7 MM/3.5 MM LOCKING COMPRESSION PLATE (LCP) POSTEROLATERAL DISTAL FIBULA PLATE AND THIRTEEN (13) SCREWS FOR A CLAVICLE FRACTURE ON (B)(6) 2017. ON UNKNOWN DATE PATIENT DEVELOPED AN INFECTION AT THE IMPLANT SITE. PATIENT WAS RETURNED TO SURGERY ON (B)(6) 2018 WHERE SURGEON REMOVED ELEVEN (11) OF THE SCREWS AND THE PLATE. IT IS UNKNOWN WHY TWO (2) OF THE SCREWS REMAIN IMPLANTED. SURGERY WAS COMPLETED. PATIENT STATUS REPORTED AS OKAY. THE PLATE AND NINE (9) SCREWS ARE CAPTURED ON (B)(4). THIS REPORT CAPTURES THE REMAINING FOUR (4) SCREWS. THIS REPORT IS FOR ONE (1) 2.7 MM LOCKING SCREW 20 MM. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 7434824 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K033995, K050110, K063049, K111540, K113364. One submission often covers many models, so check the product and lot details in each record.

• 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
• Z-0167-2016 · Oct 6, 2015 · Terminated
  2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantati
• Z-1274-2014 · Jan 7, 2014 · Terminated
  Drill Template and the Saw Guide for the Ulna Osteotomy System. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bon
• Z-0380-2014 · Jul 31, 2013 · Terminated
  2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragmen
• Z-2278-2013 · Mar 8, 2013 · Terminated
  Synthes 3.5 MM LCP(R) Distal Humerus System The Synthes 3.5 MM LCP Distal Humerus System is intended for fixation of fractures of the distal humerus, olecranon, and ulna in adults