NA 03.168.010Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 10886982274519), received between Jan 8, 2021 and Jun 17, 2026 — classified as 2 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2026Break

  IT WAS REPORTED THAT THE DEVICE HAS BROKEN THREADS ON THE TIP. DEVICE WAS DISCARDED. THERE WAS NO REPORTED PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25537470 ↗
• MalfunctionJan 16, 2026Device-Device Incompatibility

  DURING AN FNS REMOVAL, THE SURGEON INSERTED THE MULTIFUNCTION ROD WITH THE IMPACTOR ON TOP TO GRAB BOLT AND PLATE OUT. THE THREADS OF THE MULTIFUNCTION ROD WERE OVER INSERTED IN THE BOLT AND PLATE AND WILL NOT BUDGE TO COME OUT. THERE WAS NO PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24098087 ↗
• MalfunctionAug 18, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE MULTIFUNCTION ROD FROM THE FNS SET HAS WELDED INTO THE ANTIROTATION SCREW. CANNOT REMOVE AND IS NOT ADHERED TO AN IMPLANT. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22835264 ↗
• MalfunctionAug 4, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE STAPLES PRE DEPLOYED BEFORE PULLING / PUSHING BUTTON, SURGEON DID NOT WANT ANYTHING TO BE CHARGED. THE MULTIFUNCTION TOOL DID NOT THREAD, SD 2.5 HEX WAS WARPED (SD314.001).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22709756 ↗
• MalfunctionAug 4, 2025Break; Break

  IT WAS REPORTED DURING A PROCEDURE THE FEMORAL NECK SYSTEM (FSN) MISSED THE TARGETER COMPLETELY; THE DRILL WAS SET TO 95MM BUT OVERDRILLED TO 100MM. THERE WAS NO IMPACT ON THE PATIENT. IT WAS NOTED THERE WAS RUST ON THE FSN ITEMS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22701674 ↗
• MalfunctionJul 29, 2025Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THERE WAS RUST ON FEMORAL NECK SYSTEM (FNS) ITEMS, AND NEED REPLACING DUE TO FNS DRILL BIT HITTING. THE X2 CANNULATED SCREWS BROKE WHILE INSERTING IN FEMORAL NECK. THE SCREW (03.354.460) BROKE IN FEMORAL NECK. IT SNAPPED IN HALF WHILE INSERTING. THE FNS MISSED THE TARGETER COMPLETELY AND WHENEVER WE SET THE DRILL TO 95MM IT OVER DRILLED TO 100MM. IT KEPT SLIDING FOR SOME REASON. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS RELATED TO (B)(4) WHICH CAPTURES ADDITIONAL REPORTED DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22651269 ↗
• InjuryMar 10, 2025Break; Break

  IT WAS REPORTED THAT ON AN (B)(6) 2025 THE SURGEON WAS USING THE ROD FOR REMOVAL AND THE TIP OF THE ROD SNAPPED OFF INTRAOPERATIVELY DURING REMOVAL. PLATE AND SCREWS WERE REMOVED SUCCESSFULLY. THERE WAS NO ADVERSE PATIENT CONSEQUENCE AND NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 21563444 ↗
• MalfunctionJan 10, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024 DURING THE PROCEDURE, WHICH WAS THE REMOVAL OF A FEMORAL NECK SYSTEM, UPON FOLLOWING THE PROPER REMOVAL STEPS PER THE SURGICAL TECHNIQUE, THE MULTIFUNCTION ROD (03.168.010) BROKE WHILE TRYING TO REMOVE THE ANTIROTATION SCREW. SPECIFICALLY, THE END OF THE ITEM THAT CONTAINS THREADS (WHICH WAS ATTACHED TO THE ANTIROTATION SCREW) SNAPPED OFF. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO DELAYS, NEGATIVE OUTCOMES, OR INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21124451 ↗
• MalfunctionNov 4, 2024Break; Break

  IT IS REPORTED THAT DURING SURGERY, THE MULTIFUNCTIONAL BAR BROKE AT THE TIP WHEN COMPRESSION WAS DONE AND THE TIP WAS INSIDE THE ROTATING SCREW (BLUE) THAT WAS INSIDE THE PATIENT. THERE WERE NO ISSUES WITH THE SPECIALIST AND ACCORDING TO HIS INDICATION WHAT HAPPENED WITH THIS BAR WILL NOT AFFECT IN ANYTHING THE PATIENT SINCE THIS FRAGMENT WAS INSIDE THE ROTATING SCREW (BLUE). THE SURGERY WAS COMPLETED SUCCESSFULLY, WITHOUT AFFECTING THE PATIENT AND WITHOUT ALTERATIONS IN THE SURGICAL TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20600738 ↗
• MalfunctionJun 24, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON 5/27/2024 DURING A PROCEDURE AT THE HOSPITAL WITH DR. SHIN, THEY COULD NOT GET THE MULTIFUNCTION ROD TO THREAD INTO THE AIMING ARM/ANTIROTATION SCREW. ALSO, BECAUSE OF THIS, THEY WERE NOT ABLE TO GET MUCH COMPRESSION. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY, FRAGMENTS GENERATED OR THE PATIENT'S OUTCOME. NO FURTHER INFORMATION TO REPORT AT THIS TIME. THIS REPORT IS FOR ONE (1) MULTIFUNCTION ROD FOR INSERTION INSTS THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19594383 ↗
• MalfunctionAug 1, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023 WHILE EXTRACTING THE ANTI ROTATION SCREW FROM FNS SYSTEM THE MULTIFUNCTION THE ROD TIP WAS BROKEN OFF IN THE AR SCREW. A NEEDLE DRIVER WAS USED TO GRAB THE SCREW AND EXTRACT. NO SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) MULTIFUNCTION ROD FOR INSERTION INSTRUMENTS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17432108 ↗
• MalfunctionMay 3, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN INDIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE ROD FOR COMPRESSION OF FNS SYSTEM BROKE DURING SURGERY, WHEN COMPRESSION WAS APPLIED. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. DESIRED COMPRESSION WAS NOT ABLE TO BE TAKEN. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS NOT SUCCESSFULLY COMPLETED. THIS REPORT INVOLVES ONE (1) MULTIFUNCTION ROD FOR INSERTION INSTRUMENTS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16860658 ↗
• MalfunctionMar 8, 2023Break; Break

  DEVICE REPORT FROM ITALY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSERTION ROD IN QUESTION WAS FOUND TO BE BROKEN. THE EVENT OCCURRED POST-OP. THERE WAS NO REPORTED PATIENT INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A MULTIFUNCTION ROD FOR INSERTION INSTRUMENTS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16501883 ↗
• InjuryAug 2, 2022Entrapment of Device; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN INDIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE COMPRESSION DEVICE WAS BROKEN DURING COMPRESSION AND TIP OF BROKEN DEVICE IS ENGAGED WITH BLADE. SURGERY WAS DELAYED FOR 10 MINUTES DUE TO THE REPORTED EVENT. THE REPORTED PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) (B)(4). THIS IS REPORT 1 OF 1 FOR COMPLAINT MULTIFUNCTION ROD F/INSERTION INSTR.

  Patient problems: Foreign Body In Patient

  MAUDE report 15146981 ↗
• MalfunctionJan 13, 2022Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2021, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION SURGERY FOR NECK FRACTURE OF FEMUR. AFTER THE FNS WAS INSERTED, THE SURGEON TRIED TO APPLY INTER-FRAGMENTARY COMPRESSION INTRAOPERATIVELY, BUT THE COMPRESSION COULD NOT BE APPLIED BECAUSE THE SILVER CYLINDER OF THE INSERT CAME OFF AND THE BLACK RING ALSO LOOSENED. THEREFORE, THE SURGEON GAVE UP THE COMPRESSION AND TRIED TO REMOVE THE DEVICE BY COMPLETELY LOOSENING THE BLACK RING, BUT THE DEVICE DID NOT COME OFF THE IMPLANT. WHEN THE BLACK RING WAS KEPT TURNED, IT CAME OFF, AND ALL INSTRUMENTS WERE DISASSEMBLED AND COULD BE REMOVED FROM THE IMPLANT. WHEN THE SALES REP LATER CHECKED THE DEVICE, IT WAS FOUND THAT THE DEVICE, WHICH SHOULD NOT HAVE BEEN DISASSEMBLED, HAD BEEN DISASSEMBLED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A THIRTY (30) MINUTE DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) MULTIFUNCTION ROD FOR INSERTION INSTRUMENTS THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13253014 ↗
• MalfunctionJan 12, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE MULTIFUNCTIONAL ROD FOR INSERTION INSTRUMENT WHEN SCREWED INTO THE ANTIROTATION SCREW, THE THREADED PORTION BROKE OFF IN THE BACKSIDE OF THE ANTIROTATION SCREW. THERE WAS TEN (10) MINUTES SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS REPORT IS FOR ONE (1) MULTIFUNCTION ROD FOR INSERTION INSTRUMENTS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13239294 ↗
• MalfunctionNov 2, 2021Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 INTRAOPERATIVELY IT WAS IDENTIFIED THAT MULTIFUNCTION ROD F/INSERTION INSTRUMENT IS DEFECTIVE (SCREW THREAD=DEMOLISHED). NO PATIENT CONSEQUENCE REPORTED. DURING MANUFACTURER'S INVESTIGATION ON (B)(6) 2021 OF THE RETURNED DEVICE, IT WAS IDENTIFIED THAT THE DISTAL THREADED TIP OF THE DEVICE WAS BROKEN, AND BROKEN FRAGMENT WAS NOT RETURNED. THIS REPORT IS FOR ONE (1) MULTIFUNCTION ROD FOR INSERTION INSTRUMENTS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12739052 ↗
• MalfunctionAug 6, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A REVISION SURGERY DUE TO PAIN. ORIGINALLY, THE PATIENT UNDERWENT FOR A SURGERY WITH FNS IMPLANTS ON (B)(6) 2021. ON (B)(6) 2021, THE PATIENT WAS REPORTED PAIN AND SCHEDULED FOR REVISION SURGERY. IN THE REVISION, AFTER THE ANTI-ROTATION SCREW WAS REMOVED, WHEN THE SURGEON TRIED TO REMOVE THE LOCKING SCREW WITH AN EXTRACTION SCREWDRIVER, THE SCREWDRIVER BROKE, AND THE FRAGMENT WAS REMAINED IN THE SCREW HEAD. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED. CARBIDE DRILL BIT Ø4 F/INSTR (PART# 309.004S, LOT# UNKNOWN, QUANTITY# 1), DIAMOND BAR (PART# 309.004S, LOT# UNKNOWN, QUANTITY# 1), SPARECENTERPIN F/309.065 (PART# 309.670, LOT# UNKNOWN, QUANTITY# 1), UNK - NAIL HEAD ELEMENTS: FNS BOLT (PART# UNKNOWN, LOT# UNKNOWN, QTY1), UNKNOWN UNK - NAIL HEAD ELEMENTS: FNS ANTIROTATION (PART# UNKNOWN, LOT# UNKNOWN, QTY1). THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR (1) MULTIFUNCTION ROD FOR INSERTION INSTRUMENTS. THIS REPORT IS 3 OF 4 FOR (B)(4). RELATED PRODUCT CO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12288940 ↗
• MalfunctionApr 28, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING THE SURGICAL PROCEDURE ON (B)(6) 2021, THE MULTIFUNCTIONAL ROD WAS USED TO PERFORM COMPRESSION AND IT SPLIT WITHOUT CAUSING HARM TO THE PATIENT. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) MULTIFUNCTION ROD FOR INSERTION INSTRUMENTS THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11740691 ↗
• MalfunctionApr 28, 2021Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, THE MULTIFUNCTIONAL BAR USED TO PERFORM COMPRESSION BROKE WHILE IT WAS BEING MANIPULATED. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT HARM. THIS REPORT IS FOR A MULTIFUNCTION ROD FOR INSERTION INSTRUMENTS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11740307 ↗
• MalfunctionApr 13, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE MULTIFUNCTION ROD ITEM TURNED OUT TO BE DEFECTIVE. THE THREAD ON THE TIP DID NOT GO INTO THE SCREW DUE TO DAMAGE. IT WAS UNKNOWN HOW THE DAMAGE OCCURRED. IT WAS UNKNOWN IF THE SURGERY COMPLETED SUCCESSFULLY. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) MULTIFUNCTION ROD FOR INSERTION INSTS. THIS REPORT IS 1 OF 1 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11660842 ↗
• MalfunctionJan 8, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE COMPRESSION SLEEVE BROKE. THERE WAS A SURGICAL DELAY OF SIXTY (60) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) MULTIFUNCTION ROD F/INSERTION INSTR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11139928 ↗