NA 03.010.092Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 10886982067630), received between Mar 29, 2018 and Oct 15, 2025 — classified as 2 injuries, 33 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (12 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 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED ON AN UNKNOWN DATE THAT SCREWDRIVER THAT WASN'T HOLDING INTRAOPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23294099 ↗
• MalfunctionMay 22, 2025Break; Break

  IT WAS REPORTED THAT THE ITEM BROKE, NEED REPLACEMENT. NO OTHER INFORMATION WAS PROVIDED AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 22071917 ↗
• MalfunctionJun 27, 2024Break; Break

  IT WAS REPORTED DURING FIELD INSPECTION IN THE STERILE PROCESSING DEPARTMENT A SCREWDRIVER HANDLE WAS FOUND TO BE CHIPPED AFTER STERILIZATION. NO PATIENT OR SURGICAL INVOLVEMENT. THIS REPORT IS FOR ONE BALL HEX SCREWDRIVER 8MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19622926 ↗
• MalfunctionMay 22, 2024Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2024, THE SCREWDRIVER HANDLE IS PEELING OFF DURING STERILIZATION. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A BALL HEX SCREWDRIVER 8MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19376845 ↗
• MalfunctionFeb 8, 2024Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED SEVERAL TIBIAL NAIL INSTRUMENTS APPEAR WORN AND REQUIRE REPLACEMENT. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE BALL HEX SCREWDRIVER 8MM FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18670456 ↗
• MalfunctionFeb 7, 2024Break; Break

  HOLD FOR RW 2.7 DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT THE SCREWDRIVER HANDLE IS CHIPPING DURING STERILIZATION AND LEAVING MARKS IN THE SET. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) BALL HEX SCREWDRIVER 8MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18662555 ↗
• 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 AVAILA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17313226 ↗
• MalfunctionApr 19, 2023Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE CONNECTING SCREW NO LONGER RETAINED ITSELF ON THE SCREWDRIVER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WAS NO PATIENT CONSEQUENCE. THERE WAS NO DELAY IN SURGERY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE BALL HEX SCREWDRIVER 8MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16770187 ↗
• 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) BALL HEX SCREWDRIVER 8MM. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15829224 ↗
• MalfunctionMay 16, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DRIVING CAP AND BALL HEX SCREWDRIVER 8MM WERE UNABLE TO BE STERILIZED/ASSEMBLED DUE TO CHIPPING AND CRACKING. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR A BALL HEX SCREWDRIVER 8MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14413737 ↗
• MalfunctionSep 15, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  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 DIAPHYSEAL FRACTURE OF TIBIA. BEFORE THE SURGERY DURING STERILIZATION, IT WAS FOUND THAT AN UNKNOWN OILY LIQUID SUBSTANCE CAME OUT OF THE SCREWDRIVERS. THE SUBSTANCE DOES NOT APPEAR AT THE TIME OF SECOND STERILIZATION. THERE WAS NO PATIENT CONSEQUENCE. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) BALL HEX SCREWDRIVER 8MM. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12474851 ↗
• 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) BALL HEX SCREWDRIVER 8MM. THIS IS REPORT 2 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12379815 ↗
• MalfunctionAug 25, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  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 DIAPHYSEAL FRACTURE OF TIBIA. BEFORE THE SURGERY, AFTER THE STERILIZATION, IT WAS FOUND THAT THE OILY LIQUID SPREAD OUT FROM THE SCREWDRIVER. THE OILY LIQUID DROPPED ON THE CASE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH OTHER DEVICES. THIS REPORT INVOLVES ONE (1) BALL HEX SCREWDRIVER 8MM.THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12367054 ↗
• MalfunctionOct 4, 2019Break; Break

  IT WAS REPORTED ON (B)(6) 2019 DURING TIBIA OPEN REDUCTION AND INTERNAL FIXATION CASE, THE SCREW DRIVER BROKE. THE SURGEON HAD DIFFICULTY DISCONNECTING THE SUPRAPATELLAR INSERTION HANDLE FROM AN IMPLANTED TIBIAL NAIL. WHEN APPLYING FORCE INTO THE BALL HEX SCREWDRIVER, IT BROKE. ANOTHER BALL HEX SCREWDRIVER WAS USED. THERE WAS A FIFTEEN (15) MINUTE SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT STATUS IS UNKNOWN. DURING EQUIPMENT INSPECTION AFTER THE CASE IT WAS OBSERVED THAT THE INSERTION HANDLE AND CANNULATED CONNECTING SCREW WERE DAMAGED. THIS COMPLAINT INVOLVES THREE (3) DEVICES. CONCOMITANT DEVICE: UNK - NAILS: TIBIAL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN). THIS REPORT IS FOR ONE (1) BALL HEX SCREWDRIVER 8 MM. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9155546 ↗
• InjurySep 13, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, BEFORE THE SURGERY WITH EXPERT TIBIAL NAIL, THE HOSPITAL STERILIZED THE SCREWDRIVERS AND THE COMBINED HAMMER IN QUESTION. AFTER THE STERILIZATION, AN UNKNOWN BROWN OILY LIQUID HAD SEEPED OUT AND STAINED A CASE. THE PART OF THE CASE, IN WHICH THE PHENOLIC RESIN PRODUCT WAS PLACED, WAS STAINED. THE DEVICES WERE NOT USED IN THE SURGERY BECAUSE A SURGEON USED A PLATE. THE HOSPITAL DIDN'T CLEAN THE DEVICES BEFORE STERILIZATION. NO FURTHER INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 9023726 ↗
• MalfunctionAug 23, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN UNKNOWN SURGERY, A BALL HEX SCREWDRIVERS BROKE WHEN TRYING TO GET THE CONNECTING SCREW OUT. CONNECTING SCREW CONNECTS INSERTION HANDLE TO THE LATERAL ENTRY TIBIAL NAIL. DURING PROCEDURE CONNECTING SCREW WOULD NOT COME OUT OF THE NAIL. IT WAS EXTREMELY TIGHT AND BROKE THE BALL HEX SCREWDRIVER AND BENT THE CONNECTING SCREW. THERE WERE NO FRAGMENTS LEFT IN PATIENT. FINALLY, IT WAS ABLE TO GET IT OUT WITH A BACK UP DEVICE. PROCEDURE WAS COMPLETED WITH TWENTY (20) MINUTES SURGICAL DELAY. PATIENT WAS NOT AFFECTED. THIS REPORT IS FOR ONE (1) BALL HEX SCREWDRIVER 8MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8926519 ↗
• InjuryAug 14, 2018Break; Break

  CONCOMITANT DEVICE: PROXIMAL LOCKING SCREW 4X44MM (PART: UNKNOWN, LOT: UNKNOWN, QUANTITY: 1), INSERTION HANDLE FOR SUPRAPATELLAR (PART: 03.010.440, LOT: 170125-101, QUANTITY: 1).

  Patient problems: No Code Available

  MAUDE report 7782192 ↗
• MalfunctionJun 14, 2018Break; Break

  IT WAS REPORTED THAT DURING A TIBIA NAIL PROCEDURE ON (B)(6) 2018, TWO (2) BALL HEX SCREWDRIVERS BROKE WHILE ATTEMPTING TO REMOVE THE CONNECTING SCREW. THE SCREW WAS TIGHTLY PLACED AND THE FIRST SCREWDRIVER BROKE WHILE TRYING TO REMOVE IT. A SECOND SCREWDRIVER WAS USED AND THAT ALSO BROKE AT THE HEX AND DRIVE SHAFT. THE SURGEON REMOVED AND RETRIEVED THE BROKEN PIECE OF THE BALL HEX TWICE. A THIRD SCREWDRIVER WAS USED AND THE SURGEON FLEXED THE KNEE MORE AND WAS ABLE TO UNSCREW THE LOCKING BOLT. THIS CAUSED A TWO (2) MINUTE SURGICAL DELAY. THERE WAS NO HARM TO THE PATIENT. THE SURGERY WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE REPORTED: CONNECTING SCREW (PART/LOT UNKNOWN, QUANTITY 1); END CAP (PART/LOT UNKNOWN, QUANTITY 1); TIBIAL NAIL (PART/LOT UNKNOWN, QUANTITY 1). THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7602588 ↗
• MalfunctionJun 14, 2018Break; Break

  IT WAS REPORTED THAT DURING A TIBIA NAIL PROCEDURE ON (B)(6) 2018, TWO (2) BALL HEX SCREWDRIVERS BROKE WHILE ATTEMPTING TO REMOVE THE CONNECTING SCREW. THE SCREW WAS TIGHTLY PLACED AND THE FIRST SCREWDRIVER BROKE WHILE TRYING TO REMOVE IT. A SECOND SCREWDRIVER WAS USED AND THAT ALSO BROKE AT THE HEX AND DRIVE SHAFT. THE SURGEON REMOVED AND RETRIEVED THE BROKEN PIECE OF THE BALL HEX TWICE. A THIRD SCREWDRIVER WAS USED AND THE SURGEON FLEXED THE KNEE MORE AND WAS ABLE TO UNSCREW THE LOCKING BOLT. THIS CAUSED A TWO (2) MINUTE SURGICAL DELAY. THERE WAS NO HARM TO THE PATIENT. THE SURGERY WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE REPORTED: CONNECTING SCREW (PART/LOT UNKNOWN, QUANTITY 1); END CAP (PART/LOT UNKNOWN, QUANTITY 1); TIBIAL NAIL (PART/LOT UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7602577 ↗
• MalfunctionMar 30, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT FOUR (4) BALL HEX SCREWDRIVER 8MM AND FOUR (4) STARDRIVE SCREWDRIVER T25/SELF RETAINING HAVE A GREASY SUBSTANCE ON THE UNDERSIDE OF THE INSTRUMENTS. ALL EIGHT (8) INSTRUMENTS ARE FROM TWO (2) DIFFERENT STERILE TRAYS OF EX RETROGRADE ANTEGRADE FEMORAL NAIL INSTRUMENTS AND TWO (2) DIFFERENT STERILE TRAYS OF EX TIBIAL NAIL INSTRUMENTS. INSTRUMENTS HAVE BEEN REMOVED FROM CIRCULATION. NO PATIENT INVOLVEMENT WAS REPORTED. THIS REPORT IS FOR ONE (1) BALL HEX SCREWDRIVER 8MM. THIS IS REPORT 5 OF 8 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7384908 ↗
• MalfunctionMar 30, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT FOUR (4) BALL HEX SCREWDRIVER 8MM AND FOUR (4) STARDRIVE SCREWDRIVER T25/SELF RETAINING HAVE A GREASY SUBSTANCE ON THE UNDERSIDE OF THE INSTRUMENTS. ALL EIGHT (8) INSTRUMENTS ARE FROM TWO (2) DIFFERENT STERILE TRAYS OF EX RETROGRADE ANTEGRADE FEMORAL NAIL INSTRUMENTS AND TWO (2) DIFFERENT STERILE TRAYS OF EX TIBIAL NAIL INSTRUMENTS. INSTRUMENTS HAVE BEEN REMOVED FROM CIRCULATION. NO PATIENT INVOLVEMENT WAS REPORTED. THIS REPORT IS FOR ONE (1) BALL HEX SCREWDRIVER 8MM THIS IS REPORT 4 OF 8 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7384782 ↗
• MalfunctionMar 30, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT FOUR (4) BALL HEX SCREWDRIVER 8MM AND FOUR (4) STARDRIVE SCREWDRIVER T25/SELF RETAINING HAVE A GREASY SUBSTANCE ON THE UNDERSIDE OF THE INSTRUMENTS. ALL EIGHT (8) INSTRUMENTS ARE FROM TWO (2) DIFFERENT STERILE TRAYS OF EX RETROGRADE ANTEGRADE FEMORAL NAIL INSTRUMENTS AND TWO (2) DIFFERENT STERILE TRAYS OF EX TIBIAL NAIL INSTRUMENTS. INSTRUMENTS HAVE BEEN REMOVED FROM CIRCULATION. NO PATIENT INVOLVEMENT WAS REPORTED. THIS REPORT IS FOR ONE (1) BALL HEX SCREWDRIVER 8MM. THIS IS REPORT 3 OF 8 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7384774 ↗
• MalfunctionMar 30, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT FOUR (4) BALL HEX SCREWDRIVER 8MM AND FOUR (4) STARDRIVE SCREWDRIVER T25/SELF RETAINING HAVE A GREASY SUBSTANCE ON THE UNDERSIDE OF THE INSTRUMENTS. ALL EIGHT (8) INSTRUMENTS ARE FROM TWO (2) DIFFERENT STERILE TRAYS OF EX RETROGRADE ANTEGRADE FEMORAL NAIL INSTRUMENTS AND TWO (2) DIFFERENT STERILE TRAYS OF EX TIBIAL NAIL INSTRUMENTS. INSTRUMENTS HAVE BEEN REMOVED FROM CIRCULATION. NO PATIENT INVOLVEMENT WAS REPORTED. THIS REPORT IS FOR ONE (1) BALL HEX SCREWDRIVER 8MM. THIS IS REPORT 1 OF 8 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 7384756 ↗
• MalfunctionMar 29, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT WHILE NURSES SETTING UP TO PERFORM A TFN PROCEDURE NOTICED THAT THERE WAS A THIN TRANSLUCENT LAYER OF GREASE ON THE UNDERSIDE OF ITEM 357.417 AND ALSO ON THE UNDERSIDE OF ITEM 03.010.092. THEN THEY PUT THESE TRAYS TO THE SIDE AND PROCEEDED TO OPEN 8 ADDITIONAL TRAYS OF TFN INSTRUMENTS FOR A TOTAL OF 10 TRAYS THAT WERE OPENED, ALL OF WHICH THE GREASE WAS FOUND ON THE UNDERSIDE OF THE IDENTIFIED ITEMS EACH TIME, FOR A TOTAL OF 10 AFFECTED ITEMS. FIVE OF THE 357.417 AND FIVE OF THE 03.010.092. THE SURGERY WAS COMPLETED USING A SIMILAR SET OF INSTRUMENTS FROM A COMPETITOR. THERE WAS NO DELAY IN SURGERY TIME. THERE WAS NO PATIENT IMPACT. THIS IS REPORT 10 OF 10 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7382489 ↗
• MalfunctionMar 29, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT WHILE NURSES SETTING UP TO PERFORM A TFN PROCEDURE NOTICED THAT THERE WAS A THIN TRANSLUCENT LAYER OF GREASE ON THE UNDERSIDE OF ITEM 357.417 AND ALSO ON THE UNDERSIDE OF ITEM 03.010.092. THEN THEY PUT THESE TRAYS TO THE SIDE AND PROCEEDED TO OPEN 8 ADDITIONAL TRAYS OF TFN INSTRUMENTS FOR A TOTAL OF 10 TRAYS THAT WERE OPENED, ALL OF WHICH THE GREASE WAS FOUND ON THE UNDERSIDE OF THE IDENTIFIED ITEMS EACH TIME, FOR A TOTAL OF 10 AFFECTED ITEMS. FIVE OF THE 357.417 AND FIVE OF THE 03.010.092. THE SURGERY WAS COMPLETED USING A SIMILAR SET OF INSTRUMENTS FROM A COMPETITOR. THERE WAS NO DELAY IN SURGERY TIME. THERE WAS NO PATIENT IMPACT. THIS IS REPORT 9 OF 10 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7382484 ↗