NA 214.838Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10886982154682), received between Apr 3, 2018 and Jul 3, 2023 — classified as 17 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryJul 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN COLUMBIA AS FOLLOWS: IT WAS REPORTED A REVISION SURGERY OCCURRED ON AN UNKNOWN DATE IN JUNE 2023. THE TECHNICAL ASSISTANT PERFORMED THE PRE-OPERATIVE PLAN WITH THE SURGEON, WHICH WAS NOTED AS "THE PLAN IS TO REMOVE THE MEDIAL PLATE. THE LATERAL PLATE WILL BE LEFT. ONLY THE DISTAL SCREWS ARE TO BE RELEASED. THE OSTEOTOMY WILL BE PERFORMED, AND THE INSERT WILL BE PLACED TO CORRECT THE PSEUDOARTHROSIS". DURING THE PROCEDURE THE MEDIAL PLATE WAS REMOVED AND THEN THE DISTAL SCREWS OF THE LATERAL PLATE WERE REMOVED, BUT THE PLATE WAS NOT REMOVED. OSTEOTOMY WAS PERFORMED AND THE INSERT WAS PLACED, THEN PROCEEDED TO FIX THE PLATE USING NEW SCREWS FROM J&J. IT SHOULD BE NOTED THAT 2 INTERFRAGMENTARY COMPRESSION SCREWS WERE ALSO PLACED. THE PROCEDURE ENDED WITHOUT ANY NOVELTY AND WITH TOTAL NORMALITY. THE PLATE IMPLANTED IN THE PATIENT WAS FROM ANOTHER BRAND, AND THE SCREWS TO FIX THIS PLATE ARE FROM J&J. ORIGINAL IMPLANT DATE WAS NOT NOTED. THIS IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 38MM FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 17247897 ↗
• InjuryMay 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THE PATIENT UNDERWENT LEFT TOTAL KNEE ARTHROPLASTY WITH DISTAL REPLACEMENT. HARDWARE REMOVAL LEFT FEMUR DUE TO LEFT SUPRACONDYLAR/INTERCONDYLAR FEMORAL FRACTURE NONUNION, HARDWARE FAILURE AND OSTEOARTHRITIS LEFT KNEE. ON (B)(6) 2021 THE PATIENT UNDERWENT LEFT DISTAL FEMUR OPEN REDUCTION AND INTERNAL FIXATION WITH A SYNTHES LATERAL PLATE AND MULTIPLE CERCLAGE CABLES DUE TO LEFT DISTAL FEMUR COMMINUTED INTRA-ARTICULAR FRACTURE AND MORBID OBESITY. IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT HAD A FALL. SHE WAS CLIMBING OVER SOMETHING LIKE A DOG GATE, TRIPPED AND FELL. SHE INITIALLY FELT PAIN IN HER LEFT KNEE. SHE WAS DIAGNOSED WITH A LEFT DISTAL FEMUR FRACTURE. THIS COMPLAINT INVOLVES (18) DEVICES. THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 38MM.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 16940605 ↗
• InjuryMay 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2023, THERE WAS A HARDWARE REMOVAL/REVISION SURGERY DUE TO FEMORAL NONUNION. FROM THE LATERAL SIDE, THE SURGEON REMOVED A VA CONDYLAR PLATE AND CORRESPONDING SCREWS. FROM THE MEDIAL SIDE, THE SURGEON REMOVED A VA PROXIMAL TIBIA PLATE AND CORRESPONDING SCREWS. THE SURGEON THEN ADDRESSED THE NONUNION SITE, AND PLACED 2 NEW PLATES ONTO THE PATIENT'S FEMUR. THREE BROKEN SCREWS FROM THE PRIMARY SURGERY WERE RETAINED IN PATIENT'S FEMUR. THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 38MM. THIS IS REPORT 3 OF 14 FOR COMPLAINT (B)(4). ADDITIONAL DEVICES ARE REPORTED UNDER RELATED COMPLAINT (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 16896970 ↗
• InjuryApr 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2021, THE PATIENT UNDERWENT LEFT TOTAL KNEE ARTHROPLASTY WITH DISTAL REPLACEMENT. HARDWARE REMOVAL LEFT FEMUR DUE TO LEFT SUPRACONDYLAR/INTERCONDYLAR FEMORAL FRACTURE NONUNION, HARDWARE FAILURE AND OSTEOARTHRITIS LEFT KNEE. ON (B)(6) 2021 THE PATIENT UNDERWENT LEFT DISTAL FEMUR OPEN REDUCTION AND INTERNAL FIXATION WITH A SYNTHESE LATERAL PLATE AND MULTIPLE CERCLAGE CABLES DUE TO LEFT DISTAL FEMUR COMMINUTED INTRA-ARTICULAR FRACTURE AND MORBID OBESITY. IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT HAD A FALL. SHE WAS CLIMBING OVER SOMETHING LIKE A DOG GATE, TRIPPED AND FELL. SHE INITIALLY FELT PAIN IN HER LEFT KNEE. SHE WAS DIAGNOSED WITH A LEFT DISTAL FEMUR FRACTURE. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 38MM THIS IS REPORT 3 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 16723786 ↗
• 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 38MM. THIS IS REPORT 3 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15801556 ↗
• 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 DHS/DCS LAG SCREW 12.7MM THREAD/90MM THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: Necrosis

  MAUDE report 15798640 ↗
• InjuryOct 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 REMOVAL OF LARGE FRAG LATERAL PROXIMAL TIBIA PLATE DUE TO PAIN. THERE WAS NO SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. NO FRAGMENTS WERE GENERATED. PATIENT CONSEQUENCES WERE UNKNOWN. THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 38MM THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Pain

  MAUDE report 15536790 ↗
• InjuryNov 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A REMOVAL OF HARDWARE AND REVISION OF OPEN REDUCTION INTERNAL FIXATION(ORIF) LEFT FEMUR DUE TO FAILED FIXATION. LEFT HIP, FAILED DHS CONSTRUCT FOR SUBTROCH PROXIMAL FEMUR FRACTURE. THE ORIGINAL SURGERY WAS ON (B)(6) 2021. THIS REPORT IS FOR (1) 4.5MM CORTEX SCREW SELF-TAPPING 38MM. THIS IS REPORT 5 OF 7 FOR COMPLAINT (B)(4).

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

  MAUDE report 12902898 ↗
• InjuryNov 30, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, PATIENT UNDERWENT A REMOVAL OF HARDWARE AND REVISION OF OPEN REDUCTION INTERNAL FIXATION(ORIF) LEFT FEMUR DUE TO FAILED FIXATION. LEFT HIP, FAILED DHS CONSTRUCT FOR SUBTROCH PROXIMAL FEMUR FRACTURE. THE ORIGINAL SURGERY WAS ON (B)(6) 2021. THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 38MM. THIS IS REPORT 7 OF 7 FOR COMPLAINT (B)(4).

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

  MAUDE report 12902816 ↗
• InjuryNov 10, 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 FOR A SURGERY. DURING A SURGERY, THERE WAS A REVISION FIXATION DUE TO FRACTURE DISTAL TO HARDWARE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 38MM. THIS IS REPORT 2 OF 6 FOR (B)(4).

  Patient problems: Bone Fracture(s)

  MAUDE report 12788441 ↗
• InjurySep 22, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT FOR AN ORTHOPEDIC PROCEDURE. DURING THE PROCEDURE, WHILE THEY ARE FIXING A BROKEN FEMUR THE HEAD OF A 4.5MM LARGE FRAGMENT CORTEX SCREW BROKE IN THE PLATE. THE HEAD OF THE SCREW WAS REMOVED, AND THE SHAFT OF THE SCREW WAS LEFT IN THE BONE. PATIENT CONSEQUENCE IS UNKNOWN. NO SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: UNK - PLATES: FEMUR (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 1). THIS COMPLAINT INVOLVES (1) DEVICE. THIS REPORT IS FOR (1) 4.5MM CORTEX SCREW SELF-TAPPING 38MM. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 12516084 ↗
• InjurySep 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A REMOVAL PROCEDURE, THE PLATE WAS REMOVED DUE TO BONE HEALING FAILURE. THIS WAS IMPLANTED NO (B)(6) 2021. PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES (10) DEVICES. THIS REPORT IS FOR (1) 4.5MM CORTEX SCREW SELF-TAPPING 38MM. THIS REPORT IS 5 OF 10 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12502220 ↗
• InjuryJul 15, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON BROKE A CORTEX SCREW WHILE DOING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE FEMUR. THE SHAFT OF SCREW REMAINS IN THE PATIENT'S BONE AND HEAD WAS REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY REPORTED. NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 38MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 12173804 ↗
• 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 38MM. THIS IS REPORT 6 OF 15 FOR (B)(4).

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

  MAUDE report 12088598 ↗
• InjuryMay 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, PATIENT UNDERWENT A HARDWARE REMOVAL PROCEDURE DUE TO BONE HEALING. THE DOCTOR SCHEDULED A REMOVAL OF AN ANGLED BLADE PLATE AND THE PATIENT HAD A PROXIMAL FEMUR CORRECTION ON A PREVIOUS DATE. PATIENT WAS HEALED AND NO LONGER NEEDED THE IMPLANTED HARDWARE. REMOVAL WAS VERY UNEVENTFUL AND HAD NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW SELF-TAPPING 38MM. THIS IS REPORT 3 OF 5 FOR COMPLAINT (B)(4).

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

  MAUDE report 11837229 ↗
• InjuryOct 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A REVISION SURGERY OCCURRED ON (B)(6) 2020, DUE TO WOUND BREAKDOWN. ORIGINAL IMPLANT DATE UNKNOWN. THE PATIENT UNDERWENT REMOVAL OF ALL HARDWARE AND NO FRAGMENTS WERE GENERATED. ALL HARDWARE WAS REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION.. THERE IS NO SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS WAS UNKNOWN. THIS IS REPORT 2 OF 10 FOR (B)(4).

  Patient problems: Wound Dehiscence

  MAUDE report 10643048 ↗
• 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 38MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

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

  MAUDE report 8202038 ↗
• MalfunctionNov 16, 2018Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT A HIP SURGERY ON (B)(6) 2018, ONE (1) CORTEX SCREW SELF-TAPPING BROKE NEAR THE HEAD OF THE SCREW WHILE POWER DRIVING INTO THE LEFT FEMUR. THE SCREW ALREADY HAD BICORTICAL PURCHASE, NO CLINICAL SIGNIFICANCE, AND LEFT INTACT, EIGHT (8) TOTAL CORTICES PURCHASED, STABLE FOR FIXATION. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PATIENT AND PROCEDURE OUTCOME IS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN CORTEX SCREWS (PART #, LOT #, QUANTITY 7). 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 8081813 ↗
• MalfunctionApr 6, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT HAD ORIGINAL SURGERY ON (B)(6) 2018, FOR TREATMENT OF A PROXIMAL FEMUR FRACTURE. THE PATIENT WAS IMPLANTED WITH ONE (1) 130 DEGREE/62MM STANDARD BARREL 3 HOLE 62MM AND SCREWS. INTER-OPERATIVE, IT WAS REPORTED THAT A 4.5 CORTICAL SCREW BROKE DURING IMPLANTATION. THE ENTIRE HEAD OF THE SCREW BROKE OFF ALONG WITH 2MM OF THE SHAFT. THE SCREW SHAFT FRAGMENT WAS LEFT IN THE PATIENT BONE. IT WAS REPORTED THAT THE PATIENT HAD HARD BONE ON THE SPOT AND THE RESIDENT USED MORE FORCE THAN NECESSARY WHEN THE SCREW BROKE. ALL SCREW HOLE POSITION ON THE PLATE WAS FILLED. ANOTHER SCREW WAS AVAILABLE IN THE OPERATING ROOM. THIS NEW SCREW WAS IMPLANTED JUST BELOW THE SHAFT IN THE PLATE. THE BROKEN IMPLANT HAS BEEN RETAINED BY THE HOSPITAL. NO ADDITIONAL MEDICAL INTERVENTION WAS NEEDED. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO TIME DELAY. THE PATIENT IS REPORTED IN STABLE CONDITION. SALES CONSULTANT HAS NO MORE INFORMATION TO REPORT ON THIS EVENT. CONCOMITANT DEVICES: 130 DEGREE DHS® PLATE STANDARD BARREL 3 HOLES 62MM (ITEM # 281.031, LOT NUMBER UNKNOWN, QUANTITY 1 EACH) UNKNOWN SCREWDRIVER (ITEM # UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1 EACH) UNKNOWN SCREW (ITEM #

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7404522 ↗
• MalfunctionApr 3, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING A RIGHT HIP SURGICAL PROCEDURE ON (B)(6) 2018, WHILE PLACING TWO (2) SEPARATE CORTICAL SCREWS, THE SCREW HEADS BROKE, LEAVING THE BROKEN SCREW IN THE PATIENT. SURGERY WAS COMPLETED WITH NO REPORTED DELAY. THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7393703 ↗
• MalfunctionApr 3, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING A RIGHT HIP SURGICAL PROCEDURE ON (B)(6) 2018, WHILE PLACING TWO (2) SEPARATE CORTICAL SCREWS, THE SCREW HEADS BROKE, LEAVING THE BROKEN SCREW IN THE PATIENT. SURGERY WAS COMPLETED WITH NO REPORTED DELAY. THIS REPORT IS FOR ONE (1) 4.5MM CORTEX SCREW. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7393686 ↗