NA 03.010.404Recalls & reported problems

Summary

The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 10886982068569), received between Feb 14, 2017 and May 13, 2025 — classified as 6 injuries, 67 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (51 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 73 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT AN INSTRUMENT THAT WAS DELIVERED TO THE HOSPITAL WAS NOT DISASSEMBLED DURING INSPECTION. THEY COULD NOT CONFIRM PROPER DECONTAMINATION AND CLEANING PROCEDURES HAD BEEN FOLLOWED BY THE PREVIOUS FACILITY. THE HOSPITAL HAD THIS INSTRUMENT IN THEIR OWN MODULE, SO THEY COULD USE IT AND THERE WAS NO IMPACT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22010023 ↗
• MalfunctionDec 5, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THE CONNECTING SCREW THREADS WERE WORN. IT WAS DIFFICULT TO REMOVE IT FROM THE GIG INTRA-OPERATIVELY ON (B)(6) 2024. IT WAS REPORTED THERE WAS NO PATIENT HARM, NO ADVERSE EFFECTS AND NO DELAY TO THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20855011 ↗
• MalfunctionJan 5, 2024Device-Device Incompatibility; Noise, Audible; Device-Device Incompatibility; Noise, Audible

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2023, AT THE TIME OF FINISHING THE PROCEDURE, BENDING OF THE PROXIMAL PART OF THE NAIL WAS OBSERVED. IT WAS NOTED WHEN RELEASING THE CONNECTION SCREW THERE WAS BINDING, MAKING IT ALMOST IMPOSSIBLE TO REMOVE THE SCREW. THERE WAS DISCOMFORT FROM THE SPECIALIST, THE PROCEDURE WAS ACHIEVED WITH SUCCESS; HOWEVER, THE NAIL BENDING WAS NOT RESOLVED. THERE WAS AN ADDITIONAL SURGERY TIME OF 20 MINUTES APPROXIMATELY WITH ALL THE NOVELTIES PRESENTED DURING THE PROCEDURE, THERE WAS NO INVOLVEMENT OF THE PATIENT. THIS REPORT INVOLVES ONE (1) CANN CONNECTING SCR F/PERCUTAN INSTRUMENTS FOR NAILS-EX FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18452317 ↗
• MalfunctionJan 4, 2024Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON DECEMBER 11, 2023, THE CONNECTION SCREW BECAME DIFFICULT TO DISCONNECT FROM THE IMPLANT DURING THE CASE. THE DEVICE WAS PROBABLY CROSS-THREADED. THE CANNULATED SHAFT WITH 8MM HEX AND A WRENCH WERE USED TO FORCE THE CONNECTING SCREW TO DISCONNECT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A DELAY OF FIVE MINUTES. THERE WERE NO PATIENT CONSEQUENCES. THIS REPORT INVOLVES ONE CANN CONNECTING SCR F/PERCUTAN INSTRUMENTS FOR NAILS-EX. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18442782 ↗
• MalfunctionAug 14, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, TIBIAL NAIL EX SUPRAPATELLAR CONNECTING SCREW COULD NOT BE EASILY REMOVED. AFTER FIXING DISTAL THIRD TIBIA FRACTURE, NEW PROXIMAL TIBIA FRACTURE OCCURRED WHEN HAVING TO USE EXTENSIVE FORCE TRUING TO UNSCREW CONNECTING SCREW. CASE WAS EXTENDED. EXTRA SCREWS HAD TO BE INSERTED TO REPAIR NEW PROXIMAL FRACTURE. THEN CONNECTING SCREW WAS EVENTUALLY REMOVED. THERE WAS A SURGICAL DELAY OF 30 MINUTES. THE SURGERY WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A CANN CONNECTING SCR F/PERCUTAN INSTRUMENTS FOR NAILS-EX. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17540046 ↗
• MalfunctionJul 12, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT ORIF SURGERY FOR TIBIAL DIAPHYSEAL FRACTURE WITH EXPERT TIBIAL NAI, INSERTION HANDLE, CONNECTING SCREW AND SCREWDRIVER. INITIALLY, THE SURGEON PLANNED TO USE A TIBIAL NAIL 9MM OR LARGER, BUT BECAUSE THE PATIENT'S MEDULLARY CAVITY WAS NARROW, THE 8MM EXPERT TIBIAL NAIL WAS USED. APPROACHED FROM SUPRA-PATELLAR, THE EXPERT TIBIAL NAIL WAS INSERTED AFTER HAMMERING WITH SLIGHTLY MORE FORCE. AFTER FIXING THE DISTAL HOLE, THE PROXIMAL HOLE WAS FIXED AND THEN THE CONNECTING SCREW WAS TURNED TO DISCONNECT THE NAIL FROM THE INSERTION HANDLE, BUT IT COULD NOT BE TURNED AT ALL. THE SURGEON CHECKED THE IMAGE AND COULD SEE THAT THE NAIL TOP WAS DEFORMED, AND THE INSERTION HANDLE WAS STUCK IN THE NAIL AND TILTED INSTEAD OF ALIGNED. THEREFORE, THE SURGEON CONNECTED THE DRIVING CAP AND DRIVING HEAD TO THE INSERTION HANDLE AND LIGHTLY TAPPED IT OUT. THE LATERAL IMAGE CONFIRMED THAT THE THREADS WERE FINE, SO THE OPERATION WAS COMPLETED WITH INSERTION OF THE END CAP. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH 30 MINUTES OF SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17313224 ↗
• MalfunctionMay 2, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHESE REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE SURGEON HAD SIGNIFICANT DIFFICULTY REMOVING THE CONNECTING BOLT FROM THE TIBIA EX NAIL AT THE END OF THE CASE. SIGNIFICANT RESISTANCE WITH UNTHREADING THE BOLT. EVENTUALLY GOT IT OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A 5 MINUTE SURGICAL DELAY. THIS COMPLAIN INVOLVES TWO (2) DEVICE. THIS REPORT IS FOR ONE (1) CANN CONNECTING SCR F/PERCUTAN INSTS NL THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16852767 ↗
• MalfunctionApr 21, 2023Off-Label Use; Device-Device Incompatibility; Off-Label Use; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED ON THURSDAY (B)(6) 2023, THAT THEY DID A SUPRAPATELLAR TIBIAL NAIL CASE AND ONE OF THE SURGEONS DECIDED TO DO SOMETHING NOT RECOMMENDED, WHICH END UP RESULTING ON A COUPLE OF INSTRUMENTS ON THE MODULE BEING DAMAGED FOR GOOD. THE 2 ITEMS CODE ARE : 03.010.443 AND 03.010.404 BOTH OF THEM ARE NOW IMPOSSIBLE TO BE SEPARATED. THIS REPORT IS FOR ONE (1) CONNECSCR CANN F/ETN F/SUPRAPATELLAR APP THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16787310 ↗
• MalfunctionJan 5, 2023Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, IT WAS DIFFICULT TO REMOVE THE CONNECTING SCREW FROM THE NAIL. THE CONNECTING SCREW EVENTUALLY DISENGAGED, BUT THE THREADS WERE DEFORMED. THE SUPRAPATELLAR INSERTION HANDLE WAS POSSIBLY DAMAGED AT THE TIP WHEN REMOVING THE NAIL, GIVEN THE RESISTANCE OF MOVING THE CONNECTING SCREW. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE CANN CONNECTING SCR F/PERCUTAN INSTRUMENTS FOR NAILS-EX.. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16102391 ↗
• MalfunctionNov 18, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022 AFTER INSERTING A TIBIAL NAIL EX WITH PROXIMAL BEND THROUGH A SUPRAPATELLAR APPROACH, THE CONNECTING SCREW THAT ATTACHED THE SUPRAPATELLAR INSERTION HANDLE TO THE TIBIAL NAIL WOULD NOT LOOSEN, AND APPEARED THAT IT WAS "SPINNING" INSIDE THE HANDLE. THERE WAS A 25 MINUTES SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT IS FOR ONE (1) CANN CONNECTING SCR F/PERCUTAN INSTS NL THIS IS REPORT 3 OF 3 FOR COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15829450 ↗
• MalfunctionNov 17, 2022Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN DENMARK AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, THE CONNECTION SCREW AND NAIL GOT STUCK TOGETHER. THE THREAD OF THE CONNECTION SCREW AND NAIL WERE BROKEN. A T-HANDLE BECAME TWISTED BECAUSE THE SURGEON HAD TO USE EXTRA FORCE TO UNSCREW THEM. THE SURGERY WAS DELAYED BY 15 MINUTES DUE TO THIS EVENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE CANN CONNECTING SCR F/PERCUTAN INSTRUMENTS FOR NAILS-EX. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15821463 ↗
• MalfunctionOct 17, 2022Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING A TIBIAL NAIL SURGERY, THE SURGEON WAS ATTEMPTING TO DISASSEMBLE THE CONNECTING SCREW FROM THE NAIL FOLLOWING IMPLANTATION. THE CONNECTING SCREW HAD SEIZED AND APPEARED TO BE CROSS THREADED. THE SURGEON STRUGGLED MIGHTILY TO UNDO THE CONNECTING SCREW AND WAS FINALLY ABLE TO GET IT UNDONE. UPON CLOSE EXAMINATION, THE CONNECTING SCREW WAS DEEMED TO BE NO LONGER FUNCTIONAL AND IT WAS SUBSEQUENTLY DISCARDED. THERE WERE NO PATIENT CONSEQUENCES. THERE WAS A DELAY IN SURGERY OF APPROXIMATELY ONE MINUTE IN RELATION TO THE REPORTED EVENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE CANN CONNECTING SCR F/PERCUTAN INSTRUMENTS FOR NAILS-EX. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15614982 ↗
• MalfunctionSep 20, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN DENMARK AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE THREADS WERE BROKEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO DELAY DUE TO THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE CANN CONNECTING SCR F/PERCUTAN INSTRUMENTS FOR NAILS-EX. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15453750 ↗
• MalfunctionJul 18, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DURING INSPECTION AT THE HOSPITAL, IT WAS NOTICED THAT THERE WAS A DAMAGED CONNECTING SCREW AND SCREWDRIVER FROM A TIBIAL NAIL TRAY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) 4.2MM THREE-FLUTED DRILL BIT QC/NEEDLE POINT/145MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15040368 ↗
• MalfunctionMar 29, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE CONNECTING SCREW (03.010.404) THAT PASSES TO THE INSERTION HANDLE GOT STUCK INTO THE IMPLANT, TIBIA NAIL, DURING THE REMOVAL OF IT. THIS COMPLAINT INVOLVES ONE (1) DEVICE CANN CONNECTING SCR F/PERCUTAN INSTS NL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13939669 ↗
• MalfunctionFeb 18, 2022Device-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 (B)(6) 2022, THE CONNECTING SCREW WAS DIFFICULT TO DETACH FROM IMPLANT AND WAS POSSIBLE CROSS THREADED. THE IMPLANT WAS DETACHED WITH FORCE. THERE WERE NO SURGICAL DELAYS CAUSED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT INVOLVES ONE (1) CANN CONNECTING SCR F/PERCUTAN INSTRUMENTS FOR NAILS-EX. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13560796 ↗
• MalfunctionJan 11, 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, DURING REMOVAL OF THE CONNECTING SCREW, THE DEVICE NEEDED MORE TORQUE THAN NORMAL TO DISCONNECT FROM THE NAIL. NO SURGICAL DELAY REPORTED. THIS REPORT IS FOR ONE (1) CANN CONNECTING SCR F/PERCUTAN INSTS NL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13224721 ↗
• MalfunctionDec 30, 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 (B)(6) 2021, THE THREADS ON THE CANNULATED CONNECTING SCREW APPEAR STRIPPED, MAKING IT DIFFICULT TO REMOVE CONNECT OR DISCONNECT FROM NAIL. PROTECTION SLEEVES WERE JAMMED IN THE PROTECTION SLEEVE HANDLE AND ARE VERY DIFFICULT TO DISASSEMBLE. CONCOMITANT DEVICES REPORTED: UNK - NAILS(PART# UNKNOWN, LOT# UNKNOWN, QTY UNKNOWN) THIS REPORT IS FOR ONE (1) CONNECSCR CANN F/ETN F/SUPRAPATELLAR APP. THIS IS REPORT 1 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13120330 ↗
• MalfunctionDec 30, 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 (B)(6) 2021, THE THREADS ON THE CANNULATED CONNECTING SCREW APPEAR STRIPPED, MAKING IT DIFFICULT TO REMOVE CONNECT OR DISCONNECT FROM NAIL. PROTECTION SLEEVES WERE JAMMED IN THE PROTECTION SLEEVE HANDLE AND ARE VERY DIFFICULT TO DISASSEMBLE. CONCOMITANT DEVICES REPORTED: UNK - NAILS(PART# UNKNOWN, LOT# UNKNOWN, QTY UNKNOWN). THIS REPORT IS FOR (1) CONNECSCR CANN F/ETN F/SUPRAPATELLAR APP. THIS IS REPORT 5 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13120328 ↗
• MalfunctionOct 12, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING THE INSERTION OF THE NAIL, THE TARGETING ARM, STATIC ARM SCREW WAS NOT ABLE TO INSERT IN THE NAIL SO IT HAD TO BE REMOVED AND INSERT MANUALLY. UPON REMOVAL OF THE INSERTION HANDLE FROM THE NAIL, THE SURGEON COULD NOT GET THE INSERTION BOLT OUT OF THE NAIL. HAMMER WAS USED TO REMOVE THE INSERTION HANDLE. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. THIS REPORT IS FOR ONE (1) CANN CONNECTING SCR F/PERCUTAN INSTRUMENTS FOR NAILS-EX. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12617938 ↗
• MalfunctionOct 5, 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 SUPRAPATELLA NAILING PROCEDURE WAS AT THE COMPLETION STAGE AND THE SURGEON WAS ABOUT TO PUT IN AN END CAP BUT UNABLE TO REMOVE THE CONNECTING SCREW. THE SURGEON THAN REALIZED THAT THE INSERTION HANDLE HAD ROTATED DURING INSERTION WHICH LEFT IT LOOSE AGAINST THE NAIL. THIS WAS ALSO CONFIRMED WHEN WE SAW THAT ONE OF THE PROXIMAL SCREWS HAD MISSED THE NAIL EVEN THOUGH IT WENT THROUGH THE AIMING ARM. HE COULDN¿T REMOVE THE CONNECTING SCREW SO, WE REMOVED THE ENTIRE CONSTRUCT AND WERE ABLE TO SEE THAT THE NAIL HAD BEEN DAMAGED AND MANAGED TO GET THE CONNECTING SCREW TO DISENGAGE. LATER WHEN PROCEEDED TO CHECK THE INSERTION HANDLE AND BY ONLY HAVING ONE SUPRAPATELLAR KIT ON THE SHELF, MADE THE DECISION THAT ALTHOUGH THERE WAS SOME MINOR MARKS ON THE INSERTION HANDLE, WHEN WE ASSEMBLED THE NAIL AND CHECKED WITH THE AIMING ARM, IT SEEM SECURED. HOWEVER, LIKE THE FIRST TIME AT THE END, WERE ABOUT TO REMOVE THE CONNECTING SCREW TO PUT THE END CAP IN, IT WAS NOT COMING OUT AND THERE WAS SOME MOVEMENT AGAIN. FORTUNATELY, AFTER NUMEROUS TRIES, THE SURGEON WAS ABLE TO REMOVE THE CONNECTING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12579250 ↗
• MalfunctionAug 27, 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, WHILE DOING AN EXPERT TIBIAL NAIL WITH SUPRA-PATELLAR APPROACH, AFTER FINISHING OF INSERTING THE SCREWS THE SURGEON WANTED TO REMOVE THE HANDLE TO START CLOSING. THE HANDLE WAS STUCK AND THE SURGEON TRIED TO DISASSEMBLE THE CONNECTING SCREWS (BETWEEN THE HANDLE AND THE NAIL) WITH NO RESULT. SO SURGEON EVENTUALLY REMOVED THE SCREWS AND TOOK THE NAIL TOTALLY OUT OF THE PATIENT AND TRIED TO DISASSEMBLE IT OUTSIDE AND IT WORKED. THEN SURGEON ASKED TO OPEN ANOTHER NAIL (WITH SAME DIAMETER AND LENGTH) AND INSERTED NEW NAIL AND THE SCREWS. AFTER FINISHING THE SCREWS HE WAS ABLE TO REMOVE THE HANDLE NORMALLY. THE SURGERY WAS DELAYED FOR TWENTY FIVE (25) MINUTES DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO OTHER MEDICAL INTERVENTION REQUIRED. THIS REPORT IS FOR ONE (1) CANN CONNECTING SCR F/PERCUTAN INSTRUMENTS FOR NAILS-EX THIS IS REPORT 1 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12379841 ↗
• MalfunctionMay 25, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE THE CONNECTING SCREW WAS VERY DIFFICULT TO REMOVE WHILE UNSCREWING AFTER THE NAIL INSERTION AND LOCKING OPTIONS WERE COMPLETED. THERE WAS A SURGICAL DELAY OF (8) MINUTES. THE OPERATION WAS COMPLETED SUCCESSFULLY BY FITTING WITH AN 8MM BALL SCREWDRIVER AND STRAIGHT 8MM HEX SCREWDRIVER TAKEN FROM THE SUPRAPATELLAR NAIL SET. CONCOMITANT DEVICE: UNK - SCREWDRIVER: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR (1) CANN CONNECTING SCR F/PERCUTAN INSTRUMENTS FOR NAILS-EX. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11878017 ↗
• MalfunctionMay 21, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, THE INSERTION HANDLE AND CONNECTING SCREW ARE NOT ALIGNING AND CONNECTING TO THE NAIL CORRECTLY. SEND FOR A SECOND SUPRAPATELLAR SET FROM THE OTHER LEVEL ONE FACILITY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A THIRTY MINUTES SURGICAL DELAY. NO PATIENT CONSEQUENCE. CONCOMITANT DEVICES REPORTED: UNKNOWN NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1) THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) CANN CONNECTING SCR F/PERCUTAN INSTS NL. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11866715 ↗
• MalfunctionApr 15, 2021Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE TWO (2) CANNULATED CONNECTING SCREW WERE STRIPPING MAKING IT IMPOSSIBLE TO DISCONNECT THE TIBIAL NAIL AND INSERTION HANDLE. THERE WAS A SLIGHT DELAY IN REMOVING INSERTION HANDLE FROM NAIL. PROCEDURE OUTCOME AND PATIENT STATUS ARE UNKNOWN. CONCOMITANT DEVICES REPORTED: UNKNOWN TIBIAL NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). UNKNOWN INSERTION HANDLE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) CANN CONNECTING SCR F/PERCUTAN INSTRUMENTS FOR NAILS-EX. THIS REPORT IS 2 OF 2 (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11673051 ↗