NA 03.010.405Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10886982068576), received between Dec 20, 2016 and Mar 3, 2023 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 3, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM GERMANY REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, A GUIDE WIRE FOR BLADE PASSED THE NAIL EITHER VENTRALLY OR DORSALLY. SURGEON CHANGED TO OTHER PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) INSTRUMENTS. SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF APPROXIMATELY THIRTY MINUTES. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A RADIOLUCENT INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16478316 ↗
• MalfunctionNov 10, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON UNKNOWN DATE THE PATIENT UNDERWENT THE SURGERY FOR INVERTEBRAL PART WITH THE PRODUCTS IN QUESTION. DURING THE SURGERY, A 130-DEGREE DEVICE WAS CONNECTED TO A 125-DEGREE NAIL. ALTHOUGH THERE WAS SIGNIFICANT RESISTANCE DURING REAMING AND BLADE INSERTION, THE BLADE WAS FORCEFULLY TAPPED IN. WHEN THE DEVICE WAS CHECKED AT THE TIME OF DISTAL SCREW INSERTION, IT WAS NOTICED THAT THE DEVICE ANGLE WAS DIFFERENT. IT IS POSSIBLE THAT THERE IS A MALFUNCTION IN SOME OF THE INSTRUMENTS AND WILL BE CONFIRMED AT A LATER DATE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. PATIENT STATUS/ OUTCOME: STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) INSERT-HANDLE RADIOLUC F/PFNA THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15773540 ↗
• MalfunctionNov 2, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6)2022, THE PATIENT UNDERWENT SURGERY FOR FEMORAL INTERTROCHANTERIC FRACTURE. THERE WAS NO INTERFERENCE DURING DRY CHECK BEFORE NAIL INSERTION. THE SURGEON INSERTED THE NAIL WITHOUT USING A COMBINATION HAMMER. AFTER BLADE INSERTION, THE INSERTION HANDLE AND NAIL WERE SLIGHTLY LOOSE, SO THE SURGEON RETIGHTENED THEM WITH AN ONION SCREWDRIVER AND REPLACED THEM WITH ANOTHER AIMING ARM TO DRILL THE DISTAL LATERAL STOP AND WAS ABLE TO PERFORM DRILLING WITHOUT INTERFERENCE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A RADIOLUCENT INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS. THIS IS REPORT 1 OF 2 FOR PC-(B)(4). .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15713849 ↗
• MalfunctionJan 5, 2022Device-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 OPEN REDUCTION INTERNAL FIXATION SURGERY FOR TROCHANTERIC FRACTURE OF FEMUR. WHILE DRILLING THE HOLE FOR A LOCKING SCREW, THE DRILL BIT INTERFERED POSTERIOR PART ON THE HOLE OF A NAIL. THE SURGEON REMOVED THE DRILL SLEEVE AND HIT THE DRILL BIT WITH A HAMMER. BECAUSE THE DRILL BIT WAS CONTINUED TO BE HAMMERED IN THE STATE OF INTERFERING WITH THE NAIL HOLE, THE DRILL BIT GOT WORN OUT AND COULD NOT BE USED. THE SURGERY WAS COMPLETED WITHIN THIRTY (30) MINUTES DELAY. IT IS CONSIDERED THAT THERE MAY BE PROBLEMS SUCH AS DISTORTION IN INSTRUMENTS SUCH AS SLEEVE, INSERTION HANDLE, AND CONNECTING SCREW. PATIENT OUTCOME IS REPORTED AS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) UNKNOWN INSERTION HANDLE THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13171066 ↗
• MalfunctionOct 14, 2021Device-Device Incompatibility; Device-Device Incompatibility

  PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12631515 ↗
• MalfunctionAug 24, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT (B)(6) 2021, THE SCREWDRIVER DID NOT WORK AND WOULD NOT PASS THE SCREW. ANOTHER SCREWDRIVER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) RADIOLUCENT INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12360265 ↗
• MalfunctionDec 3, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2020 THAT THE THREAD OF THE INSERTION HANDLE WAS DAMAGED AND UNABLE TO CONNECT TO THE AIMING ARM. THIS WAS DISCOVERED DURING THE STERILIZATION PROCEDURE. THERE WAS NO PATIENT OR SURGICAL IMPACT. THIS REPORT IS FOR ONE (1) RADIOLUCENT INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10942279 ↗
• MalfunctionOct 12, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 THAT THE PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) WAS IMPLANTED, HOWEVER UPON ATTEMPTING TO UTILIZE THE DISTAL LOCKING OPTION THROUGH THE AIMING ARM, THE DRILL MISSED THE SCREW HOLE AND HIT THE NAIL. THERE WAS A SURGICAL DELAY OF THIRTY (30) MINUTES AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) RADIOLUCENT INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10666176 ↗
• MalfunctionMar 31, 2020Device-Device Incompatibility; Device-Device Incompatibility

  PATIENT'S OUTCOME IS REPORTED AS STABLE. CONCOMITANT DEVICES REPORTED: CONNECT-SCR-CANN F/PFN+PFNA (PART# 357.029, LOT# 2223477, QUANTITY# 1); AIM-ARM 125° F/PFNA BLADE (PART # 03.010.406, LOT # L664518, QUANTITY 1), PROTECT SLEEVE 11/8 L188 (PART # 03.025.040, LOT # L561859, QUANTITY 1), DRILL BIT Ø4.2 CALIBR L340 3FLUTE F/03.0 (PART # 03.010.061, LOT # L810568, QUANTITY 1), DRILLSL 8/4.2 F/03.010.063 (PART # 03.010.065, LOT # L491756, QUANTITY 1), TROCAR Ø4.2 F/03.010.065 (PART # 03.010.070, LOT # L674743, QUANTITY 1), UNK - NAILS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9904359 ↗
• MalfunctionNov 19, 2019Device-Device Incompatibility; Device-Device Incompatibility

  UPDATED CONCOMITANT DEVICE REPORTED: UNKNOWN PFNA NAIL (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY 1), AIMING ARM (PART# 03.037.113; LOT# 9770499; QUANTITY 1), UNK - INSERTION INSTRUMENTS: TROCAR: TRAUMA UNK - GUIDES/SLEEVES/AIMING: SLEEVE (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY 1), UNK - NUTS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY 1), UNK - IMPACTION INSTRUMENTS: CMF (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY 1), UNK - NAIL HEAD ELEMENTS: PFNA BLADE (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9342326 ↗
• MalfunctionNov 1, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT AN ISSUE OCCURRED DURING THE DISTAL LOCKING IN A PFNA SHORT 170MM/125°/D 10 MM. THE IMPLANTS ( NAIL AND SCREWS ) ARE IMPLANTED IN THE PATIENT. PATIENT CONDITION IS UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN PFNA SHORT NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1); UNKNOWN LOCKING SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS IS REPORT 1 FOR 8 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9265563 ↗
• MalfunctionAug 6, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A FEMORAL NAIL PROCEDURE ON (B)(6) 2019, THE TEAM WAS UNABLE TO CORRECTLY ALIGN THE AIMING ARM, INSERTION HANDLE, AND DRILL BIT. THERE WAS NO REPORTED PATIENT CONSEQUENCE. THIS REPORT IS FOR A RADIOLUCENT INSERTION HANDLE FOR TROCHANTERIC FIXATION NAILS. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8864379 ↗
• MalfunctionDec 3, 2018Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, THERE WAS A FUNCTIONAL ISSUE WITH AIMING ARM, HOLE FOR LOCKING BOLT AT PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) COULD NOT HIT PROPERLY. THERE WAS NO PATIENT HARM. THERE WAS NO SURGICAL DELAY REPORTED. THIS REPORT IS FOR ONE (1) RADIOLUCENT INSERTION HANDLE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8127001 ↗
• MalfunctionOct 24, 2018Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2018, THE RADIOLUCENT INSERTION HANDLE AND CONNECTOR FOR THE INSERTION HANDLE GOT BROKEN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS AND SURGICAL OUTCOME WERE ALSO UNKNOWN. THIS REPORT IS FOR ONE (1) RADIOLUCENT INSERTION HANDLE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8001971 ↗
• MalfunctionMay 22, 2018Device Operational Issue; Device Operational Issue

  DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE REMOVAL OF THE PROXIMAL FEMORAL ANTIROTATION NAIL (PFNA) FROM THE CONNECTING SCREW WAS NOT POSSIBLE. THE SURGERY WAS DELAYED ABOUT 60 MINUTES. DEVICES HAD TO BE REMOVED. SURGERY WAS COMPLETED WITH NEW PRODUCTS. SURGERY TOOK FOUR HOURS. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7535544 ↗
• MalfunctionApr 3, 2018Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) SET ITEMS BROKE WHILST DOING A CASE IN (B)(6) HOSPITAL. DEVICES WEREN¿T USED CORRECTLY. CASE WAS COMPLETED SUCCESSFULLY AND WITH NO HARM TO PATIENT EVEN WITH THE BROKEN ITEMS. THIS REPORT IS FOR ONE INSERTION-HANDLE RADIOLUC F/PFNA. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7392547 ↗
• MalfunctionFeb 20, 2018Failure to Align; Failure to Align

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, DURING A SURGERY TO TREAT THE SUB-TROCHANTERIC FRACTURE, THE DRILL HIT A NAIL AT THE TIME OF DRILLING AFTER THE DRILL SLEEVE WAS INSERTED INTO THE AIMING ARM. THE SURGEON SUCCESSFULLY COMPLETED THE SURGERY BY ADJUSTING THE DRILL ANGLE SLIGHTLY. THE OPERATION WAS DELAYED BY FIVE (5) MINUTES AND THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. SURGEON COMMENTED THAT THE CONNECTING SCREW, INSERT HANDLE AND OTHER PARTS WERE FIRMLY CONNECTED AND BENDING OF THE NAIL WAS NOT SEEN INSIDE THE BONE. THIS REPORT IS FOR ONE (1) RADIOLUCENT INSERTION HANDLE F/TROCHANTERIC FIXATION NAILS. (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7282437 ↗
• MalfunctionMar 17, 2017Failure to Align; Failure to Align

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOW: IT WAS REPORTED THAT DURING THE SURGERY ON (B)(6) 2017, WHILE DISTAL LOCKING, FAULTY LOCKING OCCURRED OF INSERTION HANDLE FOR PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) AND AIMING ARM FOR PFNA BLADE. THE SURGERY WAS PROLONGED DUE TO THE ISSUE BY 15 MINUTES. NO INFORMATION ABOUT PATIENT OUTCOME WAS REPORTED. REPORTED CONCOMITANT DEVICES: PFNA NAIL (PART # 272.265S, LOT # L235179, QUANTITY: 1). THIS REPORT IS FOR ONE (1) RADIOLUCENT INSERTION HANDLE THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6412771 ↗
• MalfunctionJan 12, 2017Failure to Align; Failure to Align

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON (B)(6), A DISTAL LOCKING OF A PROXIMAL FEMORAL NAIL ANTI-ROTATION (PFNA) SYSTEM WAS NOT ABLE TO BE USED AS PLANNED. THE LOCKING BOLT DID NOT FIT WITH THE HOLE OF THE NAIL PROPERLY. AN INSERTION HANDLE FOR PFNA, AIMING ARM, DRILL SLEEVE AND A PROTECTION SLEEVE WERE INVOLVED AS WELL. LOCKING OF THE PFNA NAIL AND LOCKING BOLT WAS ACHIEVED MANUALLY; AS SUCH IT WAS DEDUCED THAT INSERTION HANDLE FOR PFNA, AIMING ARM, DRILL SLEEVE AND A PROTECTION SLEEVE WERE MISALIGNED. THE SURGERY WAS PROLONGED BY THIRTY (30) MINUTES, BUT WITHOUT PATIENT HARM. REPORTED CONCOMITANT PARTS: PFNA NAIL (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1); LOCKING BOLT (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1). THIS IS REPORT 1 OF 2 FOR COM-(B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6245532 ↗
• MalfunctionDec 20, 2016Mechanical Jam; Mechanical Jam

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE LOCKING MECHANISM FOR THE INSERTION HANDLE AND THE AIMING ARM WAS JAMMING. THIS WAS DISCOVERED PREOPERATIVELY; THERE WAS NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR COM-(B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6190398 ↗