NA 04.005.528SRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886982085979), received between Jan 4, 2018 and Oct 18, 2024 — classified as 9 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryOct 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED REGARDING TREATMENT. PATIENT WAS GIVEN ANTIBIOTICS AND WAS NOT READMITTED.

  Patient problems: Unspecified Infection

  MAUDE report 20485490 ↗
• InjuryOct 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THERE HAS BEEN A SURGICAL SITE INFECTION AT THE HOSPITAL INVOLVING DEPUY SYNTHES DEVICES THAT WERE INVOLVED IN A HIP NAILING WITH NO FURTHER INFORMATION PROVIDED AT THIS TIME.

  Patient problems: Post Operative Wound Infection; Unspecified Infection

  MAUDE report 20370937 ↗
• InjuryJun 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT A SURGERY FOR TROCHANTERIC FRACTURE OF FEMUR. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. AFTER SURGERY, ON (B)(6) 2022, CUT-OUT OF THE BLADE AND NON-UNION WERE CONFIRMED. ON (B)(6) 2022, ALL THE IMPACTED PRODUCTS WERE EXTRACTED, AND A REVISION SURGERY WAS PERFORMED VIA BHA. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 38MM F/IM NAIL-STER. THIS IS REPORT 4 OF 6 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 14830731 ↗
• InjuryJun 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT SURGERY WITH THE NAIL, END CAP, BLADE, LOCKING SCREW AND CEMENT IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. LATER, ON (B)(6) 2022 IT WAS CONFIRMED THAT PENETRATION OF THE IMPLANT OCCURRED DUE TO OSTEONECROSIS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 38MM F/IM NAIL-STER. THIS IS REPORT 5 OF 5 FOR (B)(4).

  Patient problems: Necrosis

  MAUDE report 14828396 ↗
• InjuryFeb 4, 2022Migration; Migration

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT A REMOVAL SURGERY OF TFNA DUE TO CUT OUT CONVERTED TO TOTAL HIP. THE PROCEDURE SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME IS UNKNOWN. THIS REPORT INVOLVES ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 38MM F/IM NAIL-STER. THIS IS REPORT 1 OF 4 FOR (B)(4) .

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

  MAUDE report 13451489 ↗
• MalfunctionNov 19, 2021Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE, IT WAS NOTED WHILE INSERTING THE SCREWS, THE RESIDENT SURGEON DID NOT RECEIVE GOOD PURCHASE IN THE BONE. THE SCREW WAS EXCHANGED FOR A LONGER SCREW THAT ALSO DID NOT HAVE PURCHASE, BUT WAS ULTIMATELY ACCEPTED. THE PATIENT WAS OSTEOPOROTIC. NO ADVERSE EVENT OCCURRED AND NO BROKEN FRAGMENTS. PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 38MM F/IM NAIL-STER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12846980 ↗
• InjuryOct 20, 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 RE-OPERATION DUE TO BEING NON-COMPLIANT WITH THE PHYSICIAN'S INSTRUCTIONS WHICH RESULTED IN A NON-UNION FRACTURE. TITANIUM CANNULATED TIBIAL NAIL AND FOUR (4) LOCKING SCREWS WILL BE REMOVED. THERE WAS PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW W/T25 STARDRIVE 38MM F/IM NAIL-STER THIS IS REPORT 2 OF 5 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 12666266 ↗
• MalfunctionDec 20, 2018Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2018, DURING HIP SURGERY, UPON INSERTION OF A TITANIUM INTERLOCKING SCREW INTO A TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAIL, THE HEAD OF THE SCREW BROKE OFF. THE HEAD OF THE SCREW WAS SUCCESSFULLY REMOVED FROM THE PATIENT. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT MEDICAL PRODUCT: TFNA NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 5.0MM TI LOCKING SCREW. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8188268 ↗
• InjuryFeb 21, 2018Break; Break

  IT WAS REPORTED THAT PATIENT HAD PREVIOUS FRACTURE ON AN UNKNOWN DATE THAT WAS FIXED WITH A SYNTHES RETROGRADE/ANTEGRADE FEMORAL NAIL(RAFN) AND THREE (3) LOCKING SCREWS. TWO (2) OF THE DISTAL LOCKING SCREWS ARE BROKEN DISTALLY IN THE NAIL, THE PROXIMAL SCREW REMAINS INTACT. THE PATIENT UNDERWENT A REVISION OF THE OPEN REDUCTION OF INTERNAL FIXATION (ORIF) ON (B)(6) 2018 TO ADDRESS THE NONUNION FRACTURE THAT WAS STILL PRESENT. THE BROKEN SCREWS WERE REMOVED SUCCESSFULLY AND THE INTACT SCREW AND NAIL REMAINED IMPLANTED. A SYNTHES VARIABLE ANGLE CONDYLAR PLATE AND SCREWS WAS IMPLANTED TO ADDRESS THE NONUNION FRACTURE. CONCOMITANT DEVICES REPORTED: RETROGRADE/ANTEGRADE FEMORAL NAIL (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 5.0 MM LOCKING SCREW. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7287386 ↗
• InjuryFeb 21, 2018Break; Break

  IT WAS REPORTED THAT PATIENT HAD PREVIOUS FRACTURE ON AN UNKNOWN DATE THAT WAS FIXED WITH A SYNTHES RETROGRADE/ANTEGRADE FEMORAL NAIL(RAFN) AND THREE (3) LOCKING SCREWS. TWO (2) OF THE DISTAL LOCKING SCREWS ARE BROKEN DISTALLY IN THE NAIL, THE PROXIMAL SCREW REMAINS INTACT. THE PATIENT UNDERWENT A REVISION OF THE OPEN REDUCTION OF INTERNAL FIXATION (ORIF) ON (B)(6) 2018 TO ADDRESS THE NONUNION FRACTURE THAT WAS STILL PRESENT. THE BROKEN SCREWS WERE REMOVED SUCCESSFULLY AND THE INTACT SCREW AND NAIL REMAINED IMPLANTED. A SYNTHES VARIABLE ANGLE CONDYLAR PLATE AND SCREWS WAS IMPLANTED TO ADDRESS THE NONUNION FRACTURE. CONCOMITANT DEVICES REPORTED: RETROGRADE/ANTEGRADE FEMORAL NAIL (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1) THIS REPORT IS FOR ONE (1) 5.0MM LOCKING SCREW. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Nonunion/Delayed-union Bone Fracture

  MAUDE report 7287362 ↗
• InjuryJan 4, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A SYNTHES 11 MM TITANIUM (TI) CANNULATED TIBIAL NAIL TO TREAT AN UNKNOWN TIBIA FRACTURE ON AN UNKNOWN DATE. POSTOPERATIVELY, ON AN UNKNOWN DATE, IT WAS IDENTIFIED THAT THERE WAS A NON-UNION OF THE FRACTURE AND ON (B)(6) 2017, THE PATIENT WAS RETURNED TO THE OPERATING ROOM WHERE THE NAIL WAS REMOVED AND THE PATIENT WAS REVISED USING AN UNKNOWN TIBIAL NAIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) 5.0 MM TI LOCKING SCREW W/T25 STARDRIVE 38 MM F/IM NAIL-STERILE. THIS IS REPORT 5 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available; Nonunion/Delayed-union Bone Fracture

  MAUDE report 7164119 ↗