NA 356.830Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10886982195623), received between Jan 22, 2018 and Sep 16, 2024 — classified as 4 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 18, 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.

• MalfunctionSep 16, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE NAIL BROKE POSTOPERATIVELY. UPON RETURN OF PRODUCTS TO THE MANUFACTURER, IT WAS DISCOVERED THAT ADDITIONAL ITEMS WERE DEFORMED AND/OR BROKEN. THIS PRODUCT COMPLAINT CAPTURES THE FIRST BROKEN NAIL AND IS RELATED TO (B)(4), WHICH CAPTURES THE SECOND BROKEN NAIL.

  Patient problems: Insufficient Information

  MAUDE report 20224687 ↗
• MalfunctionSep 16, 2024Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE NAIL BROKE POSTOPERATIVELY. UPON RETURN OF PRODUCTS TO THE MANUFACTURER, IT WAS DISCOVERED THAT ADDITIONAL ITEMS WERE DEFORMED AND/OR BROKEN. THIS PRODUCT COMPLAINT CAPTURES THE FIRST BROKEN NAIL AND IS RELATED TO (B)(4), WHICH CAPTURES THE SECOND BROKEN NAIL.

  Patient problems: Insufficient Information

  MAUDE report 20224679 ↗
• MalfunctionOct 23, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SWITZERLAND REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN FEMORAL NECK OSTEOSYNTHESIS USING THE FEMORAL NECK SYSTEM (FNS) ON AN UNKNOWN DATE, THE GUIDE WIRE WENT THROUGH THE ACETABULUM AND INTO THE PELVIS. THERE SEEMED TO BE DEFECT OF THE POWER TOOL ATTACHMENT, WHICH DID NOT ALLOW THE GUIDE WIRE TO SLIDE INTO THE POWER TOOL. THE PATIENT HAD NO CONSEQUENCES, VERIFIED BY A POSTOPERATIVE CT SCAN. THIS REPORT IS FOR A GUIDE WIRE 3.2MM FOR PFNA BLADE. THIS IS REPORT 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17985544 ↗
• InjurySep 14, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT OPEN REDUCTION/INTERNAL FIXATION SURGERY WITH THE GUIDE WIRE. WHEN THE SURGEON INSERTED A BLADE, THE GUIDE WIRE PENETRATED THE FEMORAL HEAD AND ALSO PENETRATED THE ACETABULUM. AFTER INSERTING THE BLADE, THE SURGEON REMOVED THE GUIDE WIRE, BUT THE TIP OF THE GUIDE WIRE BROKE OFF AND REMAINED IN THE BODY. AFTER THE ORIF SURGERY WAS CLOSED, AT THE SENIOR SURGEON¿S DISCRETION, ANOTHER SURGEON WAS CONTACTED, AND THIS SURGEON PERFORMED A LAPAROTOMY AND REMOVED THE TIP OF THE GUIDEWIRE FROM THE ACETABULAR SIDE. THIS WAS SUCCESSFULLY REMOVED WITHOUT ANY DAMAGE TO ANY ORGANS. THE SURGERY WAS PROLONGED BY MORE THAN 120 MINUTES. THE SURGEON OPINED THAT THE BLADE HAD BEEN INSERTED WITHOUT CHECKING THE IMAGES, WHICH DELAYED THE DETECTION OF THE GUIDEWIRE PERFORATION. THIS REPORT INVOLVES ONE GUIDE WIRE 3.2MM FOR PFNA BLADE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 17746219 ↗
• InjuryJul 21, 2022Entrapment of Device; Material Deformation; Entrapment of Device; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SINGAPORE AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING A THE TROCHANTERIC FIXATION NAIL - ADVANCED (TFNA) CASE, 356.830_0761819291355 WAS INSERTED INTO THE FEMORAL HEAD, AND DRILL BIT STEPPED REAM F/TFNA HELIC BLADE+SCR F/DH WAS GUIDED INTO THE 356.830 TO DRILL. IT WAS MET WITH RESISTANCE HALFWAY THROUGH. THE SURGEON TRIED TO PUSH IN AND CONTINUE WITH THE DRILLING, BUT STILL MET WITH RESISTANCE. AN X-RAY SHOWED STEPPED REAM F/TFNA HELIC BLADE+SCR F/DH WAS CUTTING ON THE GUIDEWIRE Ø3.2 F/PFNA BLADE, AND THE GUIDEWIRE Ø3.2 F/PFNA BLADE APPEAR BENT. STEPPED REAM F/TFNA HELIC BLADE+SCR F/DH WAS REMOVED, AND FOUND NO DAMAGE TO THE DRILL BIT GUIDEWIRE Ø3.2 F/PFNA BLADE WAS REMOVED, AND METAL PARTICLES COULD BE SEEN LEFT INSIDE THE FEMORAL HEAD. SURGEON TRIED TO FLUSH OUT THE METAL PARTICLES, THERE WERE STILL METAL PARTICLE LEFT INSIDE THE FEMORAL HEAD. THE SURGEON CHANGE TO ANOTHER WIRE AND CONTINUE WITH THE SURGERY. NO PATIENT CONSEQUENCE WAS REPORTED. SURGERY WAS DELAYED 5 MINUTES DUE TO REPORTED ISSUE. THIS REPORT IS FOR ONE (1) GUIDEWIRE Ø3.2 F/PFNA BLADE. THIS IS REPORT 1 OF 2 FOR COMPLAINT PRODUCT COMPLAINT (B)(4).

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

  MAUDE report 15077011 ↗
• InjuryOct 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT FELL DOWN AND IS SCHEDULED FOR RE-OPERATION WITH THE LOCKING HIP PLATE + DHS TROCHANTER.

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

  MAUDE report 12682450 ↗
• MalfunctionJun 2, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING THE TROCHANTERIC FIXATION NAIL-ADVANCED (TFNA) IMPLANTATION ON (B)(6) 2020, THE STEPPED DRILL HAVE BROKEN OUT. THE REASON WAS NOT REPORTED. THERE WERE NO PATIENT CONSEQUENCES REPORTED. DURING MANUFACTURER'S PRELIMINARY INVESTIGATION OF THE RETURNED DEVICE ON (B)(6) 2020 IT WAS IDENTIFIED THAT AN GUIDE WIRE Ø 3.2MM JAMMED IN THE CORE HOLE OF STEPPED REAMER. THIS REPORT IS FOR ONE (1) GUIDEWIRE 3.2MM FOR PFNA BLADE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10111385 ↗
• MalfunctionJan 10, 2020Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE IN (B)(6) 2019, A GUIDE WIRE OF THE PROXIMAL FIXATION NAIL ANTI-ROTATION (PFNA) BLADE WAS DRILLED AND BROKE. NO FRAGMENTS WERE CREATED. SURGERY WAS SUCCESSFULLY COMPLETED WITH ANOTHER GUIDE WIRE. THERE WAS NO PATIENT HARM. CONCOMITANT DEVICES: AIMING ARM (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN), INSERTION HANDLE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN), DRILL SLEEVE (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN), DRILL BIT (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN), PFNA NAIL (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: UNKNOWN). THIS REPORT IS FOR A GUIDE WIRE 3.2MM FOR PFNA BLADE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9575301 ↗
• InjuryAug 13, 2018Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A PROXIMAL FEMUR NAILING ANTIROTATION (PFNA) PROCEDURE ON AN UNKNOWN DATE, DURING THE USAGE OF THE GUIDE WIRE BY THE SURGEON, HE NOTICED A DARK LIQUID LEAKING OUT OF THE DRILLING SITE. WHEN THE GUIDE WIRE WAS PULLED OUT, SEVERE DAMAGE TO THE BODY OF THE WIRE WAS CLEAR. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR A GUIDE WIRE Ø3.2 FOR PFNA BLADE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 7777686 ↗
• MalfunctionAug 7, 2018Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) CASE ON (B)(6) 2018, THE PFNA BLADE COULD NOT BE LOCKED IN PLACE. INITIALLY, IT WAS OBSERVED THAT THE UNKNOWN INSERTION HANDLE WOULD NOT LOCK INTO THE UNKNOWN PROTECTION SLEEVE, THUS NOT LOCKING THE BLADE ALL THE WAY. IN THE SURGEON¿S ATTEMPT TO REATTACH THE BLADE AND LOCK IT FULLY, THE BLADE WAS COMPLETELY SCREWED FROM ITS HOUSING INSTEAD AND COULD NOT BE RECOVERED. LOCKING THE BLADE WAS ABANDONED AND THE BLADE WAS LEFT INSIDE THE PATIENT. THE SURGEON NOTED THAT THE BLADE SHOULD HAVE A FAIL SAFE OPTION SO THAT IT CANNOT DISENGAGE AND THEREFORE ALWAYS LOCK EFFECTIVELY. IT WAS ALSO NOTED THAT THE GUIDE WIRE FOR PFNA BLADE WAS BENT WHEN IT WAS REMOVED. THERE WAS A 30-MINUTE SURGICAL DELAY REPORTED DUE TO THE DEVICE ISSUE. THE PROCEDURE WAS COMPLETED BUT WITH THE BLADE SITTING A LITTLE BIT OUT THAN IT WOULD NORMALLY BE. IT IS UNKNOWN WHAT THE PATIENT OUTCOME WAS. THIS REPORT IS FOR ONE (1) GUIDE WIRE 3.2MM FOR PFNA BLADE. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7758483 ↗
• MalfunctionJan 22, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING A PROXIMAL FEMUR NAILING ON (B)(6) 2017, A K WIRE SHEARED OFF INTRAOPERATIVELY. DURING INSERTION OF THE DRILL OVER THE K-WIRE, THE K-WIRE WAS CUT THROUGH BY THE DRILL. BACK UP INSTRUMENTATION WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY. A FIFTEEN (15) MINUTE SURGICAL DELAY WAS REPORTED. CONCOMITANT DEVICES: DRILL BIT (PART# 03.037.022, LOT# F-16763, QTY 1). INSERTION HANDLE (PART# 03.037.011, LOT# 8921813, QTY 1). CONNECTING SCREW (PART# 03.037.010, LOT# 9219128 QTY 1). AIMING ARM (PART# 03.037.114, LOT# L178546 QTY 1). TROCAR (PART# 03.037.019, LOT# 9079765, QTY 1). AIMING ARM LOCKING DEVICE (PART# 03.037.015, LOT# L122025, QTY 1). COMPRESSION NUT (PART# 03.037.016, LOT# 8947771, QTY 1). GUIDE WIRE SLEEVE (PART# 03.037.018, LOT# 8901948, QTY 1). SCREW GUIDE SLEEVE (PART# 03.037.017, LOT# 9066435, QTY 1). GUIDE WIRE (PART# 356.830, LOT# L572079 OR L572078, QTY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7209061 ↗