NA 03.010.146Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10886982067968), received between Mar 20, 2017 and Dec 23, 2025 — classified as 3 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (16 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 23, 2025Device Slipped; Device-Device Incompatibility; Device Slipped; Device-Device Incompatibility

  IT WAS REPORTED DURING THE SURGERY, AT THE TIME OF MAKING THE BLOCKAGES WITH SPIRAL BLADE, THE CONNECTING SCREW RELEASED THE EXPERT HAN NAIL. AGAIN, ATTEMPTS WERE MADE TO ATTACH THE NAIL WITH THE CONNECTION SCREW SO THAT THE INSERTION ARCH WAS WELL ADJUSTED, BUT IT WAS USELESS; THEREFORE, THE PATIENT'S PROXIMAL LOCKING SCREWS 6.0 AND 5.0 COULD NOT BE DONE THROUGH THE INSERTION ARCH AND DR., WITH THE HELP OF A BIT OF THE INSTITUTION, HE PERFORMED THE FREEHAND BLOCKAGES, THUS MANAGING TO FINISH THE SURGERY SUCCESSFULLY, WITHOUT AFFECTING THE PATIENT SURGICAL DELAY OF 10 MINUTES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23881502 ↗
• MalfunctionJun 6, 2025Break; Crack; Device-Device Incompatibility; Break; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, USER WAS UNABLE TO STERILIZE/ASSEMBLE. ITEMS WERE CHIPPING AND CRACKING. USER WAS UNABLE TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22157662 ↗
• MalfunctionApr 12, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THE EXPERT HINDFOOT NAIL SYSTEM WAS SENT TO A FACILITY FOR A PROCEDURE ON (B)(6) 2024. IN THE MIDDLE OF THE OPERATION, WHEN THE NURSE WANTED TO MOUNT THE NAIL ONTO THE INSERTION HANDLE, SHE FOUND THE HANDLE INSIDE WAS JAMMED WITH A CONNECTING SCREW. HOWEVER, THIS CONNECTING SCREW WAS CLAIMED TO BE MISSING AFTER THE LAST PROCEDURE DONE ON (B)(6) 2024. WHEN THIS CONNECTING SCREW REMOVED FROM THE INSERTION HANDLE, THE NURSES FOUND THERE WAS A LOT OF DEBRIS IN THE SCREW AND INSIDE THE INSERTION HANDLE. ALTHOUGH THERE WAS A SPARE CONNECTING SCREW IN THE LOAN KIT, THEY STILL NEEDED TO CLEAN UP THE DIRT INSIDE THE INSERTION HANDLE BEFORE IMPLANTATION. EVEN THOUGH THEY WASHED AND IMMERSED THE HANDLE MANY TIMES, THEY WERE STILL NOT ABLE TO REACH AND CLEAN UP THOROUGHLY THE DEEP INSIDE CONNECTING JUNCTION OF THE INSERTION HANDLE. SURGEON FINALLY PROCEEDED WITH THE IMPLANTATION BECAUSE OF THE TOURNIQUET TIME. THE HOSPITAL IS WORRIED ABOUT THE RISK OF INFECTION TO THE PATIENT DUE TO THE CONTAMINATION. SURGERY WAS DELAYED APPROXIMATELY 20 TO 30 MINUTES. A SPARE CONNECTING SCREW WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY. THERE IS INFECTION RISK TO THE PATIENT DUE TO INSTRUMEN

  Patient problems: Insufficient Information

  MAUDE report 19095090 ↗
• MalfunctionFeb 7, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT (B)(6) 2022, TWO(2) ITEMS BROKE DURING THE SURGERY. THE TEAM HAVE SAID THAT THESE WERE BEING USED CORRECTLY AND THIS IS A RESULT OF WEAR AND TEAR THIS REPORT IS FOR ONE (1) CONNECSCR CANN W/INTERNAL M6X1 THREAD. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13472069 ↗
• MalfunctionNov 18, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CONNECTING SCREW WAS UNABLE TO ENGAGE WITH THE NAIL. THE PROCEDURE WAS COMPLETED USING THE SECOND CONNECTING SCREW IN THE SET. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS NO SURGICAL DELAY. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) CANN CONNECTING SCR W/INTERNL THRD F/PERCUTAN INSERTN HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12834695 ↗
• MalfunctionNov 10, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING A PROCEDURE, AFTER DOING A TIBIAL NAIL, THE CONNECTING SCREW WAS VERY DIFFICULT TO LOOSEN FROM THE TIBIAL NAIL. EVENTUALLY THE NAIL WAS DISCONNECTED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS A (5) MINUTES OF SURGICAL DELAY NOTED. NO PATIENT CONSEQUENCES NOTED. THIS REPORT IS FOR (1) CANN CONNECTING SCR W/INTERNL THRD F/PERCUTAN INSERTN HANDLE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12788458 ↗
• MalfunctionNov 8, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, THE THREADS WERE BROKEN, WORN AND THE NAIL WOULD NOT ATTACH. NO BROKEN FRAGMENTS RETAINED IN THE PATIENT. HOSPITAL WAS ABLE TO FIND AN ALTERNATIVE DEVICE SO THERE WAS NO PATIENT IMPACT. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) CANN CONNECTING SCR W/INTERNL THRD F/PERCUTAN INSERTN HANDLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12771099 ↗
• MalfunctionOct 19, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON SEPTEMBER 21, 2021 THE 4.2 DRILL BIT WAS USED TO DRILL FOR A DISTAL LOCKING SCREW, WHEN IT COMES INTO CONTACT WITH THE INTRAMEDULLARY NAIL, THE TIP WEARS OUT, AND THEREFORE THE DRILL MUST BE CHANGED FOR ANOTHER, IN ORDER TO CONTINUE DRILLING. AFTER USING WITH THE FIRST SCREW, THE INTERLOCK SCREWDRIVER QUICKLY RELEASES THE SCREW. THE TIP OF THE SCREW WAS CHECKED, AND IT SEEMS THE TIP WAS BENT OR WORN. AFTER THE PLACEMENT AND LOCKING OF THE NAIL, THE INSERTION HANDLE IS REMOVED TOGETHER WITH THE CONNECTING SCREW. SINCE THE ACCESS IS SO COMPLEX, THERE IS A BIT OF DIFFICULTY WHEN REMOVING SAID SET DUE TO THE ANGULATION. IT SHOWS WEAR IN THE THREAD PASSAGES OF THE CONNECTION SCREW, THERE IS NO DAMAGE OR AFFECTION TO THE PATIENT BUT IT MAY BE RISKY TO USE IT IN A FUTURE SURGERY. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN DISTAL LOCKING SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), UNKNOWN INTRAMEDULLARY NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), UNKNOWN INSERTION HANDLE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) CONNECTER CANN W/INTERNAL M6X1 THREAD. THIS IS REPORT 2 OF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12660667 ↗
• MalfunctionOct 7, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT, DURING A PROCEDURE THE TOOTH ON THE INSERTION HANDLE BROKE OFF, NOT ALLOWING THE NAIL TO ENGAGE. THE SURGEON HAD TO SWITCH SYSTEMS AND USE ANOTHER NAIL INSTEAD. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH FIVE(5) MINUTES SURGICAL DELAY. THIS REPORT IS FOR ONE (1) CANN CONNECTING SCR W/INTERNL THRD F/PERCUTAN INSERTN HANDL. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12594561 ↗
• MalfunctionMar 16, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CONNECTION SCREW WOULD NOT CONNECT TO THE EXPERT HINDFOOT ARTHRODESIS NAIL (HAN) AND THE AIMING ARM PROPERLY. WHEN ATTEMPTING TO LOCK THE SCREW, THE AIMING ARM DISCONNECTS FROM THE SCREW. THE SCREW ONLY SCREWS ON WITH ONE TURN AND THEN STOPS. PATIENT AND PROCEDURE OUTCOME ARE UNKNOWN. THIS REPORT INVOLVES ONE (1) CANN CONNECTING SCR W/INTERNL THRD F/PERCUTAN INSERTN HANDLE. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11495092 ↗
• MalfunctionApr 16, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON MARCH 23, 2020, THE CONNECTING SCREW, CANNULATED WITH INTERNAL THREAD WAS VERY DIFFICULT TO DISENGAGE FROM EXPERT TIBIAL NAIL, CANNULATED AT THE END OF SURGERY. VICE GRIPS WERE USED AND ATTACHED TO THE BALL SCREWDRIVER TO ALLOW FOR ENOUGH LEVERAGE TO DISENGAGE THE CONNECTING BOLT. NO FRAGMENTS WERE GENERATED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: SCREWDRIVERS (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN), 10MM TI CANNULATED TIBIAL NAIL-EX/315MM-STERILE (PART NUMBER 04.004.443S, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) CANN CONNECTING SCR W/INTERNL THRD F/PERCUTAN INSERTN HANDLE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9968987 ↗
• MalfunctionFeb 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 DURING A REMOVAL OF A BROKEN NAIL AND REVISION FUSION LEFT TIBIO-TALO-CALCANEAL FUSION WITH BONE GRAFT, THAT A PATIENT ON FOLLOW UP OF PREVIOUS PROCEDURE FOUND TO HAVE BROKEN PREVIOUSLY IMPLANTED TORNIER / WRIGHT MEDICAL 611 NAIL (12MM X 180MM). BREAKAGE ABOVE THE PROXIMAL CALCANEAL SCREW. REVISION BOOKED, WITH CONSULTANT REQUESTING DPS NAIL REMOVAL, RIA AND HAN, AS WELL AS WRIGHT 611 REMOVAL SET. BROKEN NAIL EXTRACTED, WITH DIFFICULTY REMOVING PROXIMAL END OF THE BROKEN NAIL. WINDOW IN PATIENT TIBIA CREATED IN ORDER TO ASSIST WITH REMOVAL. SURGEON SELECTED HAN 13MM X 240MM LEFT NAIL, WHICH WAS CHECKED, PRIOR TO BEING ASSEMBLED ONTO AIMING DEVICE. ALIGNMENT TEST COMPLETE PRIOR TO NAIL INSERTION IN LINE WITH THE SURGICAL TECHNIQUE WITH NO FAULTS NOTED. ON INSERTION OF THE NAIL, THE SURGEON AGAIN VERIFIED NAIL IN CORRECT ALIGNMENT VIA INTRA OP X-RAY AND CONFIRMED NAIL TO BE LOCKED INTO POSITION. SURGEON ELECTED TO USE TWO DISTAL LOCKING SCREWS THROUGH NAIL AS INDICATED, HOWEVER ON PLACING PROTECTION SLEEVE IN MOST DISTAL LOCKING SCREW POSITION, AND DRILLING, FOUND THE DRILL TO BE HITTING

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9756263 ↗
• MalfunctionOct 31, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING A TIBIAL NAIL CASE THEY WERE HAVING ISSUES WITH THE AIMING ARM, DRIVING CAP, AND CONNECTING BOLT. THE BOLT AND DRIVING CAP WOULD NOT THREAD PROPERLY. THE LOCKING BOLT DID NOT SEEM TO BE CROSS THREADED, BUT THE DRIVING CAP HAD DAMAGE TO THE THREADS AND WOULD ONLY ENGAGE PARTIALLY. ACTION TAKEN WHEN THE EVENT OCCURRED HAD TO MAKE WHAT THEY HAD WORK. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT IS FOR 3 OF 3 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9262514 ↗
• MalfunctionOct 11, 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 THE HANDLE WOULD NOT CONNECT TO THE NAIL AND THEY HAD TO USE A REPLACEMENT. NO CONSEQUENCES OR IMPACT TO PATIENT. CONCOMITANT DEVICE REPORTED: UNKNOWN DRILL SLEEVE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1). THIS IS REPORT 1 FOR 1 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9180913 ↗
• 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 9118630 ↗
• MalfunctionSep 13, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING INSPECTION OF THE INSTRUMENTS AFTER GOING THROUGH THE DECONTAMINATION PROCESS, THE THREADS OF THE CANNULATED CONNECTING SCREW OR BOLT APPEARED TO BE FLATTENED AND WOULD NOT CONNECT TO AN UNKNOWN NAIL AND THE CONNECTION PART OF A QUICK COUPLING FOR SMALL AIR DRILL WAS WORN AND THERE WAS A GROOVE ON THE CONNECTION PART THAT WOULD NOT ALLOW THE PIECE TO BE INSERTED INTO THE DRILL. THERE WAS NO PATIENT AND PROCEDURE INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNKNOWN NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY#1). THIS REPORT IS FOR ONE (1) CANNULATED CONNECTION SCREW. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 9043246 ↗
• InjuryApr 8, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON WAS HAVING ISSUES WITH THE SUPRAPATELLAR NAIL CASES. FIRST ISSUE, WAS WITH EXTREME DIFFICULTY IN DISENGAGING THE CONNECTING SCREW THAT ATTACHED THE INSERTION HANDLE TO THE NAIL AT THE END OF THE CASE. THIS APPEARS TO BE CAUSED BY BENDING FORCES ON THE INSERTION HANDLE CONNECTION TO THE NAIL WHICH IN TURN INCREASES THE FRICTION OF THE CONNECTING SCREW THREADS WITH THE THREADS IN THE NAIL. SECOND ISSUE, WAS MISS TARGETING OF THE PROXIMAL HOLES IN THE NAIL. THE ISSUE WAS AFTER NAIL INSERTION AND APPEARS THERE WERE FORCES BEING APPLIED TO THE CONSTRUCT THAT CAUSE FLEX BETWEEN THE INSERTION HANDLE AND THE NAIL. WHEN USING THE LONG INSERTION HANDLE, THE TARGETING ARM SEEMS TO MISFIRE AND THE DRILL BIT SEEMS TO HIT THE NAIL WHEN PREPPING FOR PROXIMAL LOCKING SCREWS. THE CONNECTING BOLT REQUIRED A WRENCH WITH THE BALL TIP HEX TO REMOVE FROM THE NAIL. THERE WAS NO ISSUE ON THE BACK TABLE AND EVERYTHING ALIGNS. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE DELAY OF 5 MINUTES. PATIENT STATUS IS FINE. THIS REPORT IS FOR ONE (1) CANNULATED CONNECTING SCREW. THIS IS REPORT 1 OF 5 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8492699 ↗
• MalfunctionMar 29, 2019Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN OPEN REDUCTION INTERNAL FIXATION SURGERY FOR A DIAPHYSEAL FRACTURE ON (B)(6) 2019, THE CONNECTION SCREW COULD NOT BE REMOVED AFTER THE UNKNOWN NAIL WAS IMPLANTED AND SIDE-STOPPING WAS DONE. THE ISSUE WAS OBSERVED WHEN THE SURGEON ENCOUNTERED A STRONG RESISTANCE WITH AN UNUSUAL SOUND AS THE SURGEON TRIED TO ROTATE THE CONNECTION SCREW IN QUESTION TO REMOVE THE UNKNOWN INSERTION HANDLE FROM THE NAIL. THE SURGEON SUCCESSFULLY REMOVED THE CONNECTION SCREW WITH THE USE OF AN UNKNOWN DRIVER AND A WRENCH. THEN AN END CAP WAS INSERTED AND FIXED ON THE NAIL PROPERLY. THE SURGERY WAS COMPLETED WITH A THIRTY (30) MINUTES SURGICAL DELAY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICE: END CAP (PART UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) CONNECTING SCREW. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8465819 ↗
• MalfunctionJan 18, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2018, BEFORE THE SURGERY ON TITANIUM CANNULATED TIBIAL NAILS EXPERT NAILING SYSTEM, THE SCRUB TECHNICIAN OPENED THE TIBIAL NAIL EXPERT SET. IT WAS NOTICED THAT THE CANNULATED CONNECTING SCREW HAD THE LONG COMPRESSION DEVICE MECHANISM INCARCERATED WITHIN THE SCREW. THEY COULD SEPARATE THE TWO. THEY USED ANOTHER CONNECTING SCREW. PATIENT WAS NOT IN THE ROOM WHEN IT WAS NOTICED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) CONNECTING SCREW. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8262319 ↗
• MalfunctionNov 12, 2018Device Difficult to Maintain; Device Difficult to Maintain

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE. DURING THE PROCEDURE, THE SURGEON INSERTED A TIBIAL EXPERT NAIL INSTRUMENTATION AND AT THE END OF THE PROCEDURE, HE HAD A VERY DIFFICULT TIME REMOVING THE CANNULATED CONNECTING SCREW WITH INTERNAL THREAD FOR PERCUTANEOUS INSERTION HANDLE FROM THE NAIL. THE KNEE WAS FLEXED BUT THE SCREW WAS EXTREMELY HARD TO TURN. THE SURGEON THEN ASKED THAT BOTH THE INSERTION HANDLE BOLTS SHOULD BE REPLACED IN THE SET. THERE WAS NO PATIENT CONSEQUENCE REPORTED. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT AND PROCEDURE OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE UNKNOWN (1) CONNECTING SCR W/INTERNAL THIRD F/PERCUTAN INSERTN HANDLE. CONCOMITANT DEVICE REPORTED: UNKNOWN INSERTION HANDLE (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY#: 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8060528 ↗
• InjuryJun 22, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT ON (B)(6) 2018, A CANNULATED CONNECTING SCREW WOULD NOT RELEASE FROM A SUPRAPATELLAR NAIL DURING A SUPRAPATELLAR NAIL PROCEDURE OF THE TIBIA. NAIL AND SCREW REMOVAL WAS DONE SINCE THE CANNULATED CONNECTING SCREW WOULD NOT DISENGAGED FROM THE NAIL. THUS, X-RAY WAS PERFORMED SINCE THE NAIL WOULD NOT RELEASE FROM THE INSERTION HANDLE BECAUSE OF THE CANNULATED CONNECTING SCREW, THEY HAD TO REMOVE ALL SCREWS FROM THE PATIENT AND REMOVE THE NAIL AND INSERT A NEW NAIL AND NEW LOCKING SCREWS. WHEN THE NAIL WAS TAKEN OUT AND A NEW NAIL WAS INSERTED, THE CANNULATED CONNECTING SCREW WOULD NOT RELEASE AGAIN FROM THE NEW NAIL. THE TIP OF THE NAIL (1ST NAIL USED) BROKE OFF AND THERE WERE FRAGMENTS GENERATED FROM THE BROKEN NAIL. THE SURGEON DIDN¿T FIND THE PIECE UNTIL THEY DID A MRI THE NEXT DAY. THE PATIENT HAD TO BE BROUGHT BACK INTO THE OR TO REMOVE THE BROKEN TIP, ALL FRAGMENTS OF THE NAIL TIP WERE REMOVED THE NEXT DAY EASILY, WITHOUT DIFFICULTY WITHOUT HAVING TO REMOVE THE NAIL. OUTCOME WAS REPORTED AS FINE BUT THERE WAS A 70 MINUTES DELAY. SURGERY WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICE REPORTED: RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS 100MM (03.010.486, L

  Patient problems: No Code Available

  MAUDE report 7630807 ↗
• MalfunctionMay 11, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2018, THE SURGEON COULD NOT DISENGAGE THE CANNULATED CONNECTING SCREW FROM THE IMPLANTED TITANIUM CANNULATED TIBIAL NAIL. SURGEON WAS ABLE TO USE A SCREWDRIVER AND OPEN END WRENCH TO REMOVE THE CONNECTING SCREW. THERE WAS A FIVE (5) MINUTE SURGICAL DELAY. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT CONSEQUENCE. THIS COMPLAINT IS FOR A CANN CONNECTING SCR W/INTERNL THRD F/PERCUTAN INSERTN HANDLE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7508556 ↗
• MalfunctionNov 15, 2017Failure to Align; Failure to Align

  IT WAS REPORTED THAT MULTIPLE INSTRUMENTS MALFUNCTIONED DURING A LATERAL ENTRY FEMORAL NAILING TO REPAIR A MIDSHAFT FEMUR FRACTURE DUE TO A MOTOR VEHICLE ACCIDENT ON (B)(6) 2017. AFTER THE SURGEON INSERTED THE NAIL, HE INSERTED THE THREE-PART TROCAR ASSEMBLY, HE THEN CHECKED TO MAKE SURE IT WAS BEING TARGETED CORRECTLY. WHEN HE WENT TO INSERT THE GUIDE WIRE, IT KEPT HITTING THE NAIL AND WAS MISALIGNED. THE MISALIGNMENT ISSUE ONLY HAPPENED WITH ONE GUIDE WIRE AND FIRST SET OF THE THREE-PART TROCAR ASSEMBLY. LATER IN THE PROCEDURE, HE ATTEMPTED TO TAKE THE NAIL OUT, BUT THE HAMMER KEPT GETTING JAMMED AND WOULDN¿T ROCK BACK AND FORTH ON THE HAMMER GUIDE, HE STRUGGLED TO GET THE NAIL OUT. THEN, AS THE DEPTH GAUGE WAS BEING USED TO MEASURE THE LENGTH OF THE RECON SCREWS; THE SURGEON TRIED THREE TIMES AND THE MEASUREMENT WAS INACCURATE, IT WAS 10MM LONGER THAN NEEDED. THERE WAS A REPORTED SURGICAL DELAY OF 10 MINUTES TO TAKE THE NAIL OUT AND REPOSITION IT. NO ADDITIONAL X-RAYS OR OTHER MEDICAL INTERVENTION REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE PATIENT IN STABLE CONDITION. THIS COMPLAINT INVOLVES NINE (5) DEVICES. CONCOMITANT DEVICES REPORTED: HAMMER GUIDE (PART# UNK

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7035651 ↗
• MalfunctionAug 28, 2017Failure to Align; Failure to Align

  IT WAS REPORTED THAT AN INSERTION HANDLE, AIMING ARM AND CANNULATED CONNECTING SCREW FOR PERCUTANEOUS INSERTION HANDLE WERE INSTRUMENTAL IN A SCREW NOT ALIGNING WITH A NAIL ON (B)(6) 2017. THIS MISALIGNMENT OCCURRED DURING A HINDFOOT FUSION PROCEDURE LEADING TO A MINUTE SURGICAL DELAY. AN X-RAY (UNAVAILABLE) WAS TAKEN DUE TO THE MISALIGNMENT. ANOTHER SET OF INSTRUMENTS WAS READILY AVAILABLE AND PROCEDURE WAS SUCCESSFUL WITH THE PATIENT IN STABLE CONDITION. THIS COMPLAINT IS FOR THREE (3) DEVICES. CONCOMITANT DEVICES REPORTED: UNKNOWN NAIL (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY#: 1); UNKNOWN SCREW (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY#: 1). (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6825754 ↗
• MalfunctionMay 5, 2017Failure to Align; Failure to Align

  ON JUNE 18, 2017 UPDATE: A CANNULATED CONNECTION SCREW (PART NUMBER 03.010.146 AND LOT NUMBER U109603) WAS RETURNED AS A CONCOMITANT DEVICE WITHOUT AN ALLEGED COMPLAINT CONDITION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6548559 ↗