NA 214.840Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886982154699), received between May 16, 2018 and Aug 6, 2025 — classified as 8 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (6 reports).

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.

• MalfunctionAug 6, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT THERE WAS A BROKEN SCREW. THE SCREW HEAD REMOVED AND SCREW SHAFT RETAINED. LATERALITY = RIGHT, BONE = FEMUR, PROCEDURE = PROXIMAL FEMUR (HIP) OSTEOTOMY, DIAGNOSIS = ANGULAR CORRECTION.

  Patient problems: Foreign Body In Patient

  MAUDE report 22729459 ↗
• InjuryNov 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT DYNAMIC HIP SYSTEM (DHS). THERE WAS SURGICAL SITE INFECTION POSTOPERATIVE COMPLICATIONS REPORTED. PATIENT STATUS/ OUTCOME? FRACTURE UNITED AFTER REVISION WITH ANTIBIOTIC COATED IMN. THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 40MM THIS IS REPORT 4 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15801370 ↗
• InjuryNov 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT DYNAMIC HIP SYSTEM (DHS). THERE WAS AVN/OSTEONECROSIS OF THE FEMORAL HEAD POSTOPERATIVE COMPLICATIONS REPORTED. THIS REPORT IS FOR ONE (1) 135 DEG DHS PL-STD BARREL 2 HOLES/46 THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Necrosis

  MAUDE report 15800978 ↗
• InjuryNov 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED PATIENT UNDERWENT DYNAMIC HIP SYSTEM (DHS). THERE WAS AVN / OSTEONECROSIS OF THE FEMORAL HEAD POSTOPERATIVE COMPLICATIONS REPORTED. THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 40MM THIS IS REPORT 4 OF 4 FOR COMPLAINT: (B)(4).

  Patient problems: Necrosis

  MAUDE report 15798562 ↗
• MalfunctionJan 10, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE CORTEX SCREWS SELF TAPPING HEAD BROKE OFF DURING INSERTION. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT STATUS WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWDRIVER (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) 4.5MM CORTEX SCREW SELF-TAPPING 40MM. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13215431 ↗
• InjuryJun 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT HARDWARE REMOVAL OF A RIGHT FEMUR FOR OSTEOMYELITIS INFECTION. THE ORIGINAL DATE OF SURGERY WAS (B)(6) 2019. ALL HARDWARE WAS REMOVED EASILY. THERE WAS (1) POSTOPERATIVELY BROKEN SCREW. NO FRAGMENTS WERE GENERATED FROM THE BROKEN IMPLANT. THERE WAS NO SURGICAL DELAY REPORTED. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR (1) 4.5MM CORTEX SCREW SELF-TAPPING 40MM. THIS IS REPORT 15 OF 15 FOR COMPLAINT (B)(4).

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

  MAUDE report 12088887 ↗
• InjuryJun 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT HARDWARE REMOVAL OF A RIGHT FEMUR FOR OSTEOMYELITIS INFECTION. THE ORIGINAL DATE OF SURGERY WAS (B)(6) 2019. ALL HARDWARE WAS REMOVED EASILY. THERE WAS ONE (1) POSTOPERATIVELY BROKEN SCREW. NO FRAGMENTS WERE GENERATED FROM THE BROKEN IMPLANT. THERE WAS NO SURGICAL DELAY REPORTED. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 40MM. THIS IS REPORT 10 OF 15 FOR COMPLAINT (B)(4).

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

  MAUDE report 12088882 ↗
• MalfunctionAug 25, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEVICES WERE DISCOVERED AS DAMAGED AFTER THE SALES CONSULTANT RECEIVED THE ITEM SHIPMENTS. MULTIPLE PACKAGES WERE BROKEN WITH THE SCREWS REPORTED AS FLATTENED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 40MM. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10448769 ↗
• InjuryFeb 17, 2020Break; Break

  IT WAS REPORTED ON (B)(6) 2020, THE PATIENT UNDERWENT REMOVAL OF A BROKEN DHS (DYNAMIC HIP SCREW). THE 4.5 CORTEX SCREW THAT WAS BROKEN WAS 214.840. ALL IMPLANTS WERE SUCCESSFULLY REMOVED. THE PATIENT STATUS AND PROCEDURE OUTCOME ARE UNKNOWN. CONCOMITANT MEDICAL PRODUCTS: UNK - PLATES: DHS/DCS (PART# 281.102, LOT# UNKNOWN, QUANTITY# 1). UNK - NAIL HEAD ELEMENTS: DHS/DCS LAG SCREW (PART# 280.950, LOT# UNKNOWN, QUANTITY# 1). UNK - SCREWS: CORTEX (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS IS REPORT 01 OF 01 OF (B)(4).

  Patient problems: No Code Available

  MAUDE report 9716776 ↗
• InjuryDec 28, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, A DYNAMIC HIP SYSTEM (DHS) WAS REVISED DUE TO NON-UNION AND BROKEN HARDWARE. THE WASHER 13.0MM, 7.3 CANNULATED SCREW, SIDE PLATE, LAG SCREW, AND TWO (2) BROKEN 4.5MM CORTEX SCREWS WERE REMOVED SUCCESSFULLY AND REPLACED WITH A TROCHANTERIC FEMORAL NAIL SYSTEM ADVANCED (TFNA). THIS WAS ORIGINALLY IMPLANTED ON (B)(6) 2018 FOR A HIP FRACTURE. THERE WAS AN UNKNOWN SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS UNKNOWN. CONCOMITANT DEVICE: WASHER 13.0MM (PART #: 219.99, LOT #: UNKNOWN, QUANTITY: 1); 7.3MM CANNULATED SCREW 32MM THREAD/80MM (PART #: 209.880 LOT #: UNKNOWN, QUANTITY: 1); 135 DEG DHS® PLATE-STANDARD BARREL 2 HOLES/46MM M (PART #: 281.102 LOT #: UNKNOWN, QUANTITY: 1); DHS®/DCS® LAG SCREW 12.7MM THREAD/85MM (PART #: 280.850 LOT #: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 40MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Failure of Implant; Nonunion/Delayed-union Bone Fracture

  MAUDE report 8202050 ↗
• MalfunctionAug 31, 2018Break; Break

  DEVICE REPORT FROM SYNTHES (B)(4) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, DURING AN OSTEOTOMY PROCEDURE, THE FIRST CORTICAL SCREW BROKEN IN THE PATIENT WHEN IT WAS IMPLANTED. THEN, A DRILL BIT PART ALSO BROKE AND STAYED IN THE PATIENT. SURGICAL OUTCOME WAS NOT AFFECTED, THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO SURGICAL DELAY. PATIENT OUTCOME WAS NOT PROVIDED. CONCOMITANT DEVICES REPORTED: LOCKING COMPRESSION PLATE (LCP) DISTAL FEMUR PLATE - LESS INVASIVE STABILIZATION SYSTEM (LISS) (PART 222.259, LOT UNKNOWN, QUANTITY 1), 5.0 MM LOCKING SCREW, SELF-TAPPING (PART 212.214, LOT UNKNOWN, QUANTITY 3), 5.0 MM LOCKING SCREW, SELF-TAPPING (PART 212.217, LOT UNKNOWN, QUANTITY 2), 5.0 MM LOCKING SCREW, SELF-TAPPING (PART 212.219, LOT UNKNOWN, QUANTITY 1), 5.0 MM LOCKING SCREW, SELF-TAPPING (PART 212.223, LOT UNKNOWN, QUANTITY 2), 5.0 MM LOCKING SCREW, SELF-TAPPING (PART 212.224, LOT UNKNOWN, QUANTITY 2), 2.0 MM KIRSCHNER WIRE (PART 212.224, LOT UNKNOWN, QUANTITY 2). THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7838012 ↗
• InjuryMay 16, 2018Break; Break

  IT WAS REPORTED THAT THE HEAD OF A 4.5MM CORTEX SCREW BROKE OFF DURING A RETROGRADE NAILING OF MIDSHAFT OPEN FEMUR FRACTURE ON (B)(6) 2018. THE SCREW HIT THE FEMORAL NAIL AS THE SURGEON WAS INSERTING THE SCREW IN THE FEMUR; THE HEAD OF THE SCREW BROKE OFF. A CONSIDERABLE AMOUNT OF TIME WAS SPENT PERFORMING FLUOROSCOPY AND ATTEMPTING TO RETRIEVE THE SCREW. THE THREADS OF THE SCREW WERE REMOVED. THE HEAD OF THE SCREW COULD BE SEEN ON FLUOROSCOPY BUT WAS DEEP IN THE QUADRICEP MUSCLE AND COULD NOT BE RETRIEVED WITHOUT HARMING THE PATIENT. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH PATIENT OUTCOME AS EXPECTED. CONCOMITANT DEVICE REPORTED: RETROGRADE FEMORAL NAIL (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 40MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 7520238 ↗