NA 03.010.065Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10886982067395), received between Jan 5, 2017 and Jan 16, 2024 — classified as 3 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (22 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 25 most recent of 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 16, 2024Material Deformation; Material Twisted/Bent; Material Deformation; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SLEEVES ARE BENT FROM NORMAL WEAR AND TEAR. THERE WERE NO PATIENT OUTCOMES REPORTED. THIS REPORT IS FOR ONE (1) 8.0MM/4.2MM DRILL SLEEVE 200MM THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18519999 ↗
• MalfunctionNov 2, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2023, A 4.2 DRILL FOR THE DISTAL INTERLOCK SCREW IN A SHORT TFNA MISSED THE SCREW HOLE AND WENT POSTERIOR TO THE NAIL. THE CORRECT SLEEVES AND DRILL WERE USED. THE INSERTION HANDLE WAS REMOVED BECAUSE THE SURGEON NEEDED A CLEAR X-RAY TO GUIDE THE DRILL THROUGH THE NAIL-FREE HAND SURGERY. THERE IS NO "NAIL HEAD". TFNA (TROCHANTERIC FEMORAL NAIL ADVANCED). PATIENT CONSEQUENCES IN RELATION TO THE REPORTED EVENT WERE ADDED TIME AND MORE X-RAYS. THIS REPORT IS FOR ONE (1) 8.0MM/4.2MM DRILL SLEEVE 200MM THIS IS REPORT 5 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18057226 ↗
• MalfunctionSep 21, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH AN UNKNOWN DELAY.

  Patient problems: Insufficient Information

  MAUDE report 17788339 ↗
• MalfunctionMay 16, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING AN UNKNOWN PROCEDURE INNER TROCAR FOR 4.2 DRILL BIT WAS GETTING STUCK INSIDE THE OUTER SLEEVE. SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) 8.0MM/4.2MM DRILL SLEEVE 200MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16939890 ↗
• MalfunctionMay 12, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT ORIF SURGERY FOR FEMORAL TROCHANTERIC FRACTURE WITH JPFNA. AFTER ASSEMBLING THE NAIL TO THE HANDLE, THE SURGEON CHECKED THE DEVICES AND CONFIRMED THAT THERE WAS NO INTERFERENCE WITH THEM. AS THE SURGERY PROGRESSED, THE DRILL HAD DIFFICULTY ADVANCING CONTRALATERALLY WHEN DRILLING FOR A DISTAL LATERAL LOCKING. THEREFORE, ONCE THE DRILLING WAS STOPPED AND THE IMAGE WAS SLOWLY MOVED TO THE LATERAL IMAGE, IT WAS CONFIRMED THAT THE DRILL BIT WAS NOT PASSING THROUGH THE NAIL. THE SURGEON PULLED OUT THE DRILL, ADJUSTED THE HANDLE AND SLEEVE TO ALLOW THE DRILL TO PASS THROUGH WHILE CHECKING WITH THE LATERAL VIEW, DRILLED, AND WAS ABLE TO PASS THE DRILL THROUGH THE NAIL. THE DISTAL LATERAL LOCKING SCREW WAS THEN MEASURED AND INSERTED. FINALLY, THE LATERAL LOCKING SCREW WAS PASSED THROUGH THE HOLE IN THE NAIL TO ENSURE THAT IT WAS FASTENED IN PLACE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES. THE PATIENT WAS REPORTED AS STABLE. THIS REPORT INVOLVES ONE (1) 8.0MM/4.2MM DRILL SLEEVE 200MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16917923 ↗
• MalfunctionDec 27, 2022Contamination /Decontamination Problem; Device-Device Incompatibility; Contamination /Decontamination Problem; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE AIMING ARM WAS OUT OF CALIBRATION. WHEN THE DRILL BIT WAS PASSED THROUGH IT DID NOT COINCIDE WITH THE HOLE OF THE NAIL AND THE BIT GOT STUCK. THE TISSUE PROTECTION SLEEVE AND THE DRILL SLEEVE WERE DIRTY WITH DEBRIS INSIDE. FOR THIS REASON, THE DOCTOR CHANGED THE SURGICAL PLAN. THERE WAS A DELAY IN THE PROCEDURE AS A RESULT. THE PATIENT WAS AFFECTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 8.0MM/4.2MM DRILL SLEEVE 200MM. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16053211 ↗
• MalfunctionNov 14, 2022Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  SURGERY WAS DELAYED FOR 2 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15789777 ↗
• MalfunctionSep 12, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING SUPRAPATELLAR INSERTION OF AN ADVANCED NAILING SYSTEM (ANS), TIBIA NAIL ADVANCED (TNA) INTRAMEDULLARY NAIL, THE SURGEON WAS NOT ABLE TO PUT A 5.0MM INTERLOCK IN THE MOST DISTAL PROXIMAL STATIC INTERLOCK. THIS WAS THE MOST DISTAL OF THE PROXIMAL INTERLOCKS THAT ARE TARGETED THROUGH THE AIMING ARM. THEY ATTEMPTED TO RELIEVE FROM PRESSURE ON THE SYSTEM BY PLACING A BUMP UNDER THE PATIENT¿S KNEE, PUTTING THE KNEE INTO MORE OF A FLEXED POSITION BUT THE LONG 4.2MM DRILL BIT WAS STILL HITTING THE NAIL AND NOT GOING THROUGH THE INTERLOCK HOLE. THEY WERE EVENTUALLY ABLE TO FIND THE CORRECT PATH BY STARTING WITH A LONG 3.2MM DRILL BIT, THEN DRILLING WITH THE LONG 4.2MM DRILL BIT. BUT WHEN THEY WENT TO INSERT THE 5.0MM INTERLOCK THE SCREW ONLY MADE IT THROUGH THE NEAR CORTEX AND WAS SPINNING, LIKELY CONTACTING THE NAIL OR FAR CORTEX INSTEAD OF PASSING THROUGH THE DRILLED HOLE. THEY WERE NOT ABLE TO PUT AN INTERLOCK THROUGH THIS HOLE AND HAD TO USE A PROXIMAL OBLIQUE INSTEAD. PROXIMAL TARGETED SCREW INSERTION THROUGH THE AIMING ARM AND LONG INSERTION HANDLE WAS OFF. THE DRILL BIT WAS HITTING THE NAIL INSTEAD OF GOING THROUGH THE INTERLOCK HOLE IN THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15403002 ↗
• MalfunctionAug 9, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT - 03.010.041 B 14.0/3.2 MM PUNZÓN, DAMAGED CANULATED. REPLACE. 03.010.063 HYSTIC PROTECTION PLANE 12.0/8.0, LONGITUD 188 MM, AND A - 03.010.065 BIT GUIDE 8.0/4.2, FOR PART NO. 03.010.063, VERY DIFFICULT TO REMOVE FROM EACH OTHER, CHECK THERE WAS NO SURGICAL DELAY. THERE WAS ALTERATION OF THE TECHNIQUE BY ANOTHER SURGICAL OPTION EXISTING IN THE SURGICAL INSTRUMENT, WITH NO IMPACT ON THE SURGERY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1)DRILLSL 8/4.2 F/03.010.063 THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15190824 ↗
• MalfunctionMar 25, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE INTRAMEDULLARY NAIL FIXATION SURGERY WITH THE MHN FOR THE FRACTURE OF THE PROXIMAL HUMERUS. WHEN THE SURGEON INSERTED THE LOCKING SCREW THROUGH THE PROTECTION SLEEVE, THE SCREW HEAD DID NOT PENETRATE THE PROTECTION SLEEVE. WHEN THE SURGEON PULLED OUT THE PROTECTION SLEEVE TO CHECK HOW FAR THE SCREW HAD GONE, THE LOCKING SCREW AND THE PROTECTION SLEEVE CAME OUT. IT WAS CONFIRMED THAT THE SCREW HEAD INTERFERED WITH THE TIP OF THE PROTECTION SLEEVE MANY TIMES, AND THE TIP OF THE PROTECTION SLEEVE WAS SLIGHTLY SQUASHED INWARD. THE SURGEON USED ANOTHER PROTECTION SLEEVE TO INSERT THE LOCKING SCREW. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THIRTY(30) MINUTES OF SURGICAL DELAY. THIS REPORT IS FOR ONE (1) DRILLSL 8/4.2 F/03.010.063. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13904852 ↗
• MalfunctionNov 26, 2021Degraded; Material Deformation; Degraded; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT DEVICES ARE RECEIVED AS BLIND UNIT THOSE ARE NOT ASSOCIATED WITH A COMPLAINT. THIS COMPLAINT WAS CREATED TO ANALYZE. THERE WAS NO PROCEDURE AND PATIENT INVOLVEMENT REPORTED. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR (1) 8.0MM/4.2MM DRILL SLEEVE 200MM. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12878251 ↗
• MalfunctionAug 23, 2021Calibration Problem; Calibration Problem

  IT WAS REPORTED THAT, DURING TESTING AT SERVICE AND REPAIR, A TORQUE WRENCH FAILED IN CALIBRATION. .NO PATIENT INVOLVEMENT. THIS REPORT IS FOR (1) 8.0MM/4.2MM DRILL SLEEVE 200MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12356188 ↗
• MalfunctionJul 30, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING AN OPERATION AN INSERTION HANDLE, DRILL SLEEVE AND TROCAR BROKE WHILE BEING USED. THERE WERE NO BROKEN FRAGMENTS GENERATED. THE SURGEON HAD TO FINISH THE OPERATION WITHOUT THE INSTRUMENTS. THERE WAS A SURGICAL DELAY OF FIFTEEN (15) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT WAS STABLE AFTER EVENT. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 8.0MM/4.2MM DRILL SLEEVE 200MM. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12252378 ↗
• MalfunctionJul 22, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON UNKNOWN DATE, PATIENT WILL UNDERGO A TFNA PROCEDURE. DURING STERILE PROCESSING, WHILE CHECKING PROTECTION SLEEVE FOR SHORT TFNA BEFORE INSERTING TFNA NAIL AND IT WAS MISALIGNED. NO PATIENT CONSEQUENCES NOTED. THE PROCEDURE OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES (4) DEVICES. THIS REPORT IS FOR (1) DRILL SL 8/4.2 F/03.010.063. THIS REPORT IS 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12215050 ↗
• MalfunctionJun 15, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, WHEN THE SURGEON WAS INSTALLING A TIBIA NAIL USING OUR SUPRAPATELLAR TIBIA NAILING SYSTEM, UNABLE TO GET THE PROXIMAL LOCKING SCREWS THROUGH THE NAIL USING THE AIMING ARM AND THE DEVICES MAY BE OUT OF ALIGNMENT. IT IS UNKNOWN IF FRAGMENTS GENERATED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNK: SCREW (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). UNK: NAILS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES (7) DEVICES. THIS REPORT IS FOR (1) 8.0MM/4.2MM DRILL SLEEVE 200MM. THIS REPORT IS 5 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12004771 ↗
• MalfunctionApr 26, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021 WHILE DRILLING FOR THE DISTAL SCREW OF A RETROGRADE/ANTEGRADE FEMORAL NAIL, THROUGH THE SPIRAL BLADE ATTACHMENT, THE DRILL BIT AND SCREW BOTH SKIVED POSTERIORLY MISSING THE NAIL ALL TOGETHER. THE SCREW WAS ABORTED AND THE SPIRAL BLADE WAS COMPLETED WITHOUT INCIDENT. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY REPORTED. THIS REPORT IS FOR ONE (1) 8.0MM/4.2MM DRILL SLEEVE 200MM. THIS IS REPORT 3 OF 10 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11725331 ↗
• MalfunctionDec 28, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE, WHILE DRILLING, THE SURGEON HIT THE NAIL AND DEVICES (INSERTION HANDLE, CANNULATED SCREW, PROTECTION SLEEVE, DRILL SLEEVE, AIMING ARM FOR SUPRATELLAR, TITANIUM CANNULATED TIBIAL NAIL, AND DRILL BIT) DID NOT LINE UP COMPLETELY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. NO PATIENT CONSEQUENCES. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS IS REPORT 4 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11078231 ↗
• MalfunctionDec 4, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN EXPERT TIBIAL NAIL INSERTION PROCEDURE ON (B)(6) 2020, THE DRILL BIT MADE CONTACT WITH NAIL WHILE DRILLING FOR THE PROXIMAL SCREW. THE DEVICE WAS CHECKED AFTER THE PROCEDURE AND SHOWED EVERYTHING WAS CORRECTLY ALIGNED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH TWO (2) MINUTES SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) 8.0MM/4.2MM DRILL SLEEVE 200MM. THIS IS REPORT 1 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10943235 ↗
• MalfunctionJul 16, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, DURING AN UNKNOWN PROCEDURE, DURING DRILLING FOR PROXIMAL UNKNOWN SCREWS, THE DRILL BIT WAS CONTACTED NAIL AND WITH AN UNKNOWN ISSUE. THE SURGEON SUCCESSFULLY PASSED THE UNKNOWN SCREW AND AFTER THE SURGERY, THE GUIDE/ DRILL SLEEVE LINED UP. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME WAS UNKNOWN. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR (1) 8.0MM/4.2MM DRILL SLEEVE 200MM. THIS IS REPORT 2 OF 6 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10285999 ↗
• MalfunctionJun 26, 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 DURING AN UNKNOWN PROCEDURE, AT THE TIME OF THE RECONSTRUCTION TECHNIQUE, THE GUIDE WIRE WENT OUTSIDE THE FEMORAL HEAD AND THEN THE NAIL WAS SLIGHTLY REMOVED. THE PROTECTION SLEEVE WAS PLACED AGAIN WITH THE DRILL SLEEVE TO CARRY OUT THE INSERTION OF THE GUIDE WIRE AGAIN. IT HAPPENED THAT THIS COLLIDED WITH THE NAIL AND DID NOT PASS. THE SURGEON PERFORMED A MANEUVER WITH A TISSUE PROTECTION SHEATH SO THE GUIDE WIRE COULD BE PLACED IN THE FEMORAL HEAD. IT WAS ALSO NOTED THAT THE FLEXIBLE SHAFT TIP WAS DETERIORATED AND DID NOT GRIP THE MILLING HEADS WELL. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR ONE (1) 8.0MM/4.2MM DRILL SLEEVE 200MM. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10201642 ↗
• InjuryJun 26, 2020Device-Device Incompatibility; No Apparent Adverse Event; Device-Device Incompatibility; No Apparent Adverse Event

  THE INITIAL COMPLAINT WAS REVIEWED AND FOUND TO BE A DUPLICATE OF COMPLAINT (B)(4). THIS DEVICE HAS ALREADY BEEN CAPTURED ON MANUFACTURER REPORT NUMBER 8030965-2020-04491.

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 10200389 ↗
• MalfunctionMay 27, 2020Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING INSPECTION AND ASSEMBLY OF THE TIBIAL NAIL SET, THE THREE (3) INTERLOCKING DEVICES (4.2MM TROCAR 210MM, 8.0MM/4.2MM DRILL SLEEVE 200MM, AND 12.0MM/8.0MM PROTECTION SLEEVE 188MM) APPEARED TO BE BENT. THE ITEMS WERE POSSIBLY DAMAGED DURING DECONTAMINATION. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 8.0MM/4.2MM DRILL SLEEVE 200MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10092333 ↗
• MalfunctionApr 27, 2020Device-Device Incompatibility; Device-Device Incompatibility

  CONCOMITANT DEVICE REPORTED: AIMING ARM LOCKING DEVICE (PART NUMBER: 03.037.015, LOT NUMBER: 9501063, QUANTITY: 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10003493 ↗
• 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); INSERT-HANDLE RADIOLUC F/PFNA (PART # 03.010.405, LOT # 7595885, 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), AIM-ARM 125° F/PFNA BLADE (PART # 03.010.406, LOT # L664518, 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 9904366 ↗
• InjurySep 25, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING A LEFT HINDFOOT ARTHRODESIS WITH NAIL PROCEDURE ON (B)(6) 2019, THE AIMING ARM ASSEMBLY MISALIGNED BOTH PROXIMAL SCREWS. THE SURGEON INSERTED A LEFT EXPERT HINDFOOT NAIL. IT WAS CONFIRMED THE NAIL WAS LOADED PROPERLY ONTO INSERTION HANDLE BY CONFIRMING THE BEND OF THE NAIL MATCHED THE ETCHED PICTURE ON THE INSERTION HANDLE. THE SURGEON ALSO TESTED THE AIMING ARM BEFORE INSERTION INTO PATIENT BY PUTTING THE TRIPLE TROCAR ASSEMBLY AND CORRESPONDING DRILL BIT THROUGH THE CORRESPONDING NAIL HOLES. WITH THE NAIL INSERTED AND THE AIMING ARM IN (P) POSITION, THE SURGEON INSERTED TWO (2) 6.0 MM SCREWS INTO THE CALCANEUS WITHOUT ISSUE. HE ALSO DRILLED AND INSERTED THE OBLIQUE 5.0 MM SCREW INTO THE TALUS WITHOUT ISSUE. WHEN THE SURGEON TRIED TO DRILL THROUGH THE (TWO) 2 (CORRECT) PROXIMAL HOLES LABELLED (STATIC) AND (180) THE 4.2 MM DRILL BIT ENCOUNTERED THE NAIL ITSELF AND COULD NOT PASS THROUGH THE DESIGNATED NAIL HOLES. FOR THESE PROXIMAL SCREWS THE AIMING ARM SHOWED (M) IN THE WINDOW AS APPROPRIATE AND HE USED TRIPLE TROCAR ASSEMBLY WITH DRILL BIT, WHICH WERE THE SAME ITEMS HE HAD USED FOR THE TALAR

  Patient problems: Injury; No Code Available

  MAUDE report 9118785 ↗