NA 03.010.101Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10886982067685), received between Oct 25, 2017 and Apr 7, 2026 — classified as 7 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2026Device-Device Incompatibility; Material Deformation

  DURING SURGERY, THE SPECIALIST BENT THE CALIBRATED 4.2 DRILL BIT. WHILE DRILLING, IT BECAME STUCK TO THE IMPLANT AND BENT DUE TO THE FORCE OF THE MOTOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24800491 ↗
• MalfunctionApr 6, 2026Device-Device Incompatibility

  IT WAS DIFFICULT TO REMOVE THE DRILL BIT. ANOTHER DRILL BIT WAS MENTIONED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24790488 ↗
• MalfunctionFeb 26, 2026Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT A HUMERAL SHAFT FRACTURE SYNOSTOSIS WITH THE DRILL BIT. IN THE MHN LONG DISTAL HOLE, WHERE A 3.2MM DRILL SHOULD HAVE BEEN USED, A 4.2MM DRILL WAS MISTAKENLY USED AND A 4.0MM SCREW WAS INSERTED. SINCE FIXATION BETWEEN THE BONE AND THE SCREW WAS NOT ACHIEVED, THERE IS A RISK OF THE SCREW BACKING OUT. THERE IS ALSO A RISK OF REOPERATION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24457344 ↗
• MalfunctionFeb 26, 2026Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT A HUMERAL SHAFT FRACTURE SYNOSTOSIS WITH THE DRILL BIT. IN THE MHN LONG DISTAL HOLE, WHERE A 3.2MM DRILL SHOULD HAVE BEEN USED, A 4.2MM DRILL WAS MISTAKENLY USED AND A 4.0MM SCREW WAS INSERTED. SINCE FIXATION BETWEEN THE BONE AND THE SCREW WAS NOT ACHIEVED, THERE IS A RISK OF THE SCREW BACKING OUT. THERE IS ALSO A RISK OF REOPERATION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24457322 ↗
• MalfunctionFeb 26, 2026Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT A HUMERAL SHAFT FRACTURE SYNOSTOSIS WITH THE DRILL BIT. IN THE MHN LONG DISTAL HOLE, WHERE A 3.2MM DRILL SHOULD HAVE BEEN USED, A 4.2MM DRILL WAS MISTAKENLY USED AND A 4.0MM SCREW WAS INSERTED. SINCE FIXATION BETWEEN THE BONE AND THE SCREW WAS NOT ACHIEVED, THERE IS A RISK OF THE SCREW BACKING OUT. THERE IS ALSO A RISK OF REOPERATION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24457311 ↗
• MalfunctionFeb 26, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT AN ORIF FOR RIGHT SIDE FEMORAL SHAFT FRACTURE WITH THE POWER TOOL. A SHORT-SIZED RFNA WAS ORIGINALLY INSERTED, SO AFTER REMOVAL OF THE NAIL, A 340MM ONE WAS REINSERTED. THE OPERATION PROCEEDED SMOOTHLY FROM INSERTING THE NAIL TO STOPPING THE DISTAL LOCKING. THE RADIOLUCENT DRIVE WAS USED FOR THE PROXIMAL LOCKING STAGE. A DRILL HOLE WAS CREATED USING AN INTRAMEDULLARY NAIL DRILL, AND THE RADIOLUCENT DRIVE WAS USED. THE POSITION WAS INCORRECT THE FIRST TIME, SO THE POSITION WAS CORRECTED AND THE DRILL WAS DRILLED AGAIN. WHEN DRILLING AGAIN, THE ROTATION WAS REVERSED, AND THE DRILL ATTACHED TO THE RADIOLUCENT DRIVE BECAME STUCK. USING THE RADIOLUCENT DRIVE WAS DISCONTINUED, AND THE TECHNIQUE WAS CHANGED TO FREEHAND, USING THE 4.2MM-145MM DRILL INCLUDED IN THE IMPLANT SET. AFTER SWITCHING TO FREEHAND, THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30MINS OF DELAY. NO FURTHER INFORMATION IS AVAILABLE. (B)(4) IS RELATED TO (B)(4), WHICH REPORTS ON A PTS PRODUCT. (B)(4) REPORTS ON SYN PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24453996 ↗
• MalfunctionFeb 25, 2026Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT ORIF SURGERY WITH MULTILOC HUMERAL NAILS (MHN) LONG FOR HUMERAL SHAFT FRACTURES. THE DISTAL HOLE SHOULD HAVE BEEN DRILLED WITH THE 3.2MM DRILL BIT, BUT INSTEAD IT WAS DRILLED WITH A 4.2MM DRILL BIT, AND A 4.0MM SCREW WAS INSERTED. THE SURGEON NOTED THAT THERE IS A POSSIBILITY OF SCREW BACKOUT BECAUSE FIXATION BETWEEN THE BONE AND THE SCREW WAS NOT ACHIEVED. THERE IS ALSO A POSSIBILITY THAT REVISION SURGERY WILL BE REQUIRED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN A 30-MINUTE DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24443911 ↗
• MalfunctionFeb 9, 2026Insufficient Device Problem Information

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT SURGERY WITH TNA. THE DRILL BIT IN QUESTION WAS USED FIRST, THEN A RADIOLUCENT DRIVE WAS CONNECTED. AFTER CONFIRMING THAT THE CONNECTION WAS SECURE, THE SURGEON BEGAN DRILLING, BUT THE DRILL DID NOT ADVANCE. AFTER DRILLING FOR A WHILE, A WHITE, POWDERY SUBSTANCE EMERGED. DECIDING THAT SOMETHING WAS WRONG, THE SURGEON STOPPED DRILLING AND CHECKED THE DEVICE, AND FOUND THAT ALTHOUGH THE CONNECTION WAS SECURE, THE DRILL BIT WAS NOT ROTATING. THE SURGEON TRIED TO REPLACE THE DRILL BIT WITH A SPARE, BUT IT WAS STUCK SO TIGHTLY THAT PLIERS HAD TO BE USED TO REMOVE IT FROM THE DEVICE. WHEN THE DRILL BIT WAS REMOVED, IT WAS FOUND THAT THE CONNECTION POINT WITH THE RADIOLUCENT DRIVE WAS WORN OUT AND BLACK. AFTER REPLACING IT WITH THE SPARE DRILL BIT, DRILLING WAS PERFORMED WITHOUT ANY PROBLEMS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES OF DELAY. NO FURTHER INFORMATION IS AVAILABLE. DURING MANUFACTURER'S INVESTIGATION OF THE RETURNED SECOND DRILL BIT IT WAS IDENTIFIED THAT PROXIMAL AREA OF THE DEVICE APPEARS TO HAVE A BLACK FOREIGN SUBSTANCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24293087 ↗
• MalfunctionDec 5, 2025Device-Device Incompatibility; Material Twisted/Bent; Device-Device Incompatibility; Material Twisted/Bent

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT SURGERY WITH TNA. THE DRILL BIT IN QUESTION WAS USED FIRST, THEN A RADIOLUCENT DRIVE WAS CONNECTED. AFTER CONFIRMING THAT THE CONNECTION WAS SECURE, THE SURGEON BEGAN DRILLING, BUT THE DRILL DID NOT ADVANCE. AFTER DRILLING FOR A WHILE, A WHITE, POWDERY SUBSTANCE EMERGED. DECIDING THAT SOMETHING WAS WRONG, THE SURGEON STOPPED DRILLING AND CHECKED THE DEVICE, AND FOUND THAT ALTHOUGH THE CONNECTION WAS SECURE, THE DRILL BIT WAS NOT ROTATING. THE SURGEON TRIED TO REPLACE THE DRILL BIT WITH A SPARE, BUT IT WAS STUCK SO TIGHTLY THAT PLIERS HAD TO BE USED TO REMOVE IT FROM THE DEVICE. WHEN THE DRILL BIT WAS REMOVED, IT WAS FOUND THAT THE CONNECTION POINT WITH THE RADIOLUCENT DRIVE WAS WORN OUT AND BLACK. AFTER REPLACING IT WITH THE SPARE DRILL BIT, DRILLING WAS PERFORMED WITHOUT ANY PROBLEMS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES OF DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23727301 ↗
• MalfunctionNov 26, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON NOV 7, 2025, THE PATIENT UNDERWENT AN ORIF FOR TIBIAL SHAFT FRACTURE. DURING A TNA OPERATION, THE SURGEON DRILLED USING THE RELEVANT INSTRUMENT TO INSERT A DISTAL LOCKING SCREW. AN ABNORMAL NOISE WAS HEARD DURING DRILLING AND THE INSTRUMENT BECAME STUCK. AFTER ROTATING IT IN THE CORRECT DIRECTION SEVERAL TIMES, THE RADIOLUCENT DRIVE BEGAN TO ROTATE SIGNIFICANTLY, SO THE RELEVANT INSTRUMENT AND THE TRS WERE ALLOWED TO COOL FOR A WHILE AND DRILLING WAS PERFORMED AGAIN. WHEN THE INSTRUMENT STOPPED STARTING UP DURING DRILLING, IT WAS ALLOWED TO COOL AGAIN AND AN ATTEMPT WAS MADE TO CHANGE THE BATTERY AND DRILL TIP, BUT IT WOULD NOT COME OFF THE RADIOLUCENT DRIVE. THE NURSE TRIED TO PULL IT OUT, BUT IT WOULD NOT COME OFF, SO THE CHANGE WAS ABANDONED. THE NURSE HAD THE DRILL TIP CLEANED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30MINS OF DELAY. AFTER THE SURGERY, THE DRILL TIP WAS GRASPED WITH THE T-HANDLE AND PULLED OUT, AND A BLACK OBJECT, LIKELY FROM THE RADIOLUCENT DRIVE, WAS FOUND ATTACHED TO THE WHITE RESIN PART AT THE BASE. NO FURTHER INFORMATION IS AVAILABLE. THIS PC IS RELATED TO PC-(B)(4) WHICH REPORTS ON THE PTS PRODUCT. THIS PC REPORTS ON THE SYN P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23658823 ↗
• MalfunctionAug 11, 2025Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON (B)(6), 2025, THE PATIENT UNDERWENT ORIF SURGERY FOR A HUMERAL SHAFT FRACTURE. THE DRILL BIT ROTATED ALONG THE HORIZONTAL AXIS. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22772737 ↗
• MalfunctionJun 24, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT ORIF SURGERY FOR TIBIA FRACTURE WITH THE RADIOLUCENT DIVE. WHEN THE SURGEON WAS USING THE RADIOLUCENT DRIVE DURING THE SURGERY, THE DRILL BIT WOULD NOT TURN DUE TO GOOD BONE QUALITY. THAT MADE THE RADIOLUCENT DRIVE HOT AT THE DRILL CONNECTION POINT. WHEN THE DRIVE WAS MOVED OUT OF THE SURGICAL FIELD AND OPERATED ON THE INSTRUMENT TABLE TO CHECK, THE DRILL TIP CAME OFF, FLEW OFF, HIT THE CEILING AND FELL. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES OF DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS RELATED TO (B)(4), WHICH REPORTS ABOUT THE RADIOLUCENT DRIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22320205 ↗
• MalfunctionMar 4, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH MULTILOC LONG NAIL AND RADIOLUCENT-DRIVE. IN THE SURGERY, WHEN INSERTING THE DISTAL LOCKING SCREW, THE SURGEON TRIED TO ATTACH THE RADIOLUCENT DRIVE TO THE TRS, BUT THE UNEVEN TUBE PART DID NOT GO ALL THE WAY IN. ALTHOUGH IT WAS NOT FULLY ATTACHED, THE DRILL TIP ROTATED, SO THE SURGEON ATTEMPTED TO DRILL IN THE SURGICAL FIELD, BUT THE ROTATION FORCE WAS INSUFFICIENT AND IT COULD NOT BE ROTATED. AFTER SEVERAL ATTEMPTS, THE SURGEON USED AN AO COUPLING AND CHANGED TO THE FREE DRILL TECHNIQUE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH THIRTY MINUTES SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 21515154 ↗
• MalfunctionSep 17, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN ORIF FOR DISTAL FEMORAL DIAPHYSEAL FRACTURE. DURING DRILLING, SOMETHING THAT LOOKED LIKE A BLACK PIECE OF PLASTIC CAME OUT. THE SURGEON TOOK IT OFF ONCE TO CHECK. THERE WAS A PLASTIC PIECE ON THE CONNECTION PART, AND THE CONNECTION PART OF DRILL WAS BLACK. THE CONNECTION PART WAS FLUSHED WITH SALINE, AND ANOTHER DRILL WAS ATTACHED. THEN, A SCREW WAS INSERTED. THE PLASTIC PIECES THAT FELL INTO THE BODY WERE REMOVED WITH GAUZE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. PATIENT WAS STABLE. THIS REPORT IS FOR A 4.2MM THREE-FLUTED RADIOLUCENT DRILL BIT/NEEDLE POINT/145MM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20240382 ↗
• MalfunctionSep 12, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT UNDERWENT AN ORIF WITH THE DRILL BIT IN QUESTION. THE CORTICAL BONE WAS HARD, AND THE POWER TOOL WAS GETTING HOT FROM CONTINUAL DRILLING. AFTER THE PROCEDURE, THE DRILL BIT COULD NOT BE REMOVED FROM THE RADIOLUCENT DRIVE. HOWEVER, THE DRILL BIT WAS SUCCESSFULLY REMOVED AND IT TOOK TIME TO COME OFF. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 4.2MM THREE-FLUTED RADIOLUCENT DRILL BIT/NEEDLE POINT/145MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20206533 ↗
• MalfunctionAug 15, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN ORIF SURGERY FOR A HUMERAL DIAPHYSEAL FRACTURE. THE RADIOLUCENT DRIVE WAS PREPARED FOR INSERTING A DISTAL LOCKING SCREW TO A MULTILOC NAIL LONG. A NURSE WRONGLY ATTACHED THE DRILL BIT WITH THE GREEN LINE IN QUESTION TO THE RADIOLUCENT DRIVE WITHOUT NOTICING THAT IT WAS NOT FOR THIS PROCEDURE. THE SURGEON THOUGHT THE DRILL BIT WAS THICKER THAN USUAL, WHICH TURNED OUT THAT THE ATTACHED DRILL BIT WAS WRONG. THE EVENT OCCURRED DURING THE SALES REP WAS OUT OF THE OPERATION ROOM TEMPORARILY. AFTER RETURNING TO THE OPERATION ROOM, THE SALES REP NOTICED THE MISTAKE AND INFORMED THE NURSE TO EXCHANGE THE DRILL BIT IN QUESTION TO THE DRILL BIT WITH BLUE LINE. THE SALE REP WAS ABLE TO PREVENT PROBLEMS BEFORE THEY OCCURRED. THERE WERE SEVERAL DRILL BITS IN THE OPERATION ROOM. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE PATIENT WAS REPORTED AS STABLE. THIS REPORT INVOLVES ONE (1) 4.2MM THREE-FLUTED RADIOLUCENT DRILL BIT/NEEDLE POINT/145MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19989787 ↗
• MalfunctionMay 8, 2024No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN UNKNOWN SURGERY FOR A FRACTURE OF THE FEMORAL SHAFT. THE RADIOLUCENT DRIVE WAS NO LONGER ABLE TO OPERATE IN THE MIDDLE OF THE PROCESS BECAUSE IT COULD NOT COUNTERACT THE TORQUE APPLIED DURING THE DRILLING OF THE PROXIMAL SCREW HOLE. THEREFORE, THE RADIOLUCENT DRIVE ARRANGED AS A SPARE WAS USED, BUT IT COULD NOT COUNTERACT THE TORQUE EITHER AND STOPPED WORKING. THE SURGEON OPENED THE DRILL BIT Ø4.2 CALIBR L145 3FLUTE F/QUIC AND DRILLED WITH IT MANUALLY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THIS REPORT IS FOR ONE 4.2MM THREE-FLUTED RADIOLUCENT DRILL BIT/NEEDLE POINT/145MM FOR (B)(4). THIS PC IS RELATED TO 9B)(4) WHICH CAPTURES PTS PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19267408 ↗
• MalfunctionMar 15, 2024Break; Device-Device Incompatibility; Noise, Audible; Break; Device-Device Incompatibility; Noise, Audible

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN ORIF SURGERY TREATING A FEMORAL SHAFT. DURING DRILLING, AN ABNORMAL NOISE WAS HEARD, AND THE DRILL STOPPED ROTATING. THE SURGEON ATTEMPTED TO DETACH THE DRILL BIT, BUT WAS UNABLE TO DO SO, SO HE DRILLED MANUALLY AND INSERTED A SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A SURGICAL DELAY OF 30 MINUTES. THE PATIENT OUTCOME IS STABLE. AFTER THE SURGERY, THE DRILL BIT WAS ABLE TO BE DETACHED BY A UNIVERSAL T HANDLE. HOWEVER, THE CONNECTION PART MELTED, AND BLACK RESIN ADHERED TO THE ROOT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 4.2MM THREE-FLUTED RADIOLUCENT DRILL BIT/NEEDLE POINT/145MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18914285 ↗
• MalfunctionDec 21, 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 SURGERY FOR A TIBIAL DIAPHYSEAL FRACTURE WITH THE TNA. IN THE SURGERY, THE DRILL TIP IN QUESTION INTERFERED WITH THE NAIL WHEN DRILLING THE AP HOLE DURING FIXATION OF THE DISTAL LATERAL STOP SCREW. IT IS POSSIBLE THAT THE INLAY WAS SLIGHTLY SHAVED OFF IN DOING SO. THE DIRECTION OF THE DRILL TIP WAS CHANGED, DRILLING WAS PERFORMED AGAIN, AND THE SCREW INSERTION WAS SUCCESSFULLY COMPLETED. THE SURGEON CONFIRMED THAT THERE WERE NO PIECES IN THE PATIENT¿S BODY. THIS REPORT INVOLVES ONE 4.2MM THREE-FLUTED RADIOLUCENT DRILL BIT/NEEDLE POINT/145MM. THIS IS REPORT 1 OF 2 FOR PC-(B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18377964 ↗
• MalfunctionJul 5, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHESE REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT DURING AN OPEN REDUCTION/INTERNAL FIXATION SURGERY ON (B)(6) 2023, AFTER INSERTING THE SCREW PROXIMALLY, WHEN DRILLING A REGULAR CIRCLE (AP DIRECTION) HOLE WITH THE RADIOLUCENT DRIVE, THE DRILL BIT INTERFERED WITH THE NAIL AND SPUN OUT, BECOMING UNUSABLE. THE RADIOLUCENT DRIVE WAS COOLED WITH SALINE SOLUTION AND DRILLING WAS ATTEMPTED AGAIN, BUT DID NOT WORK PROPERLY, SO THE SCREWS WERE THEN INSERTED BY FREEHAND DRILLING. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN A 30-MINUTE DELAY. THE PATIENT STATUS WAS REPORTED TO BE STABLE. THE SURGEON CONFIRMED BY X-RAY THAT THERE WERE NO PIECES LEFT IN THE PATIENT¿S BODY. THIS REPORT INVOLVES ONE 4.2MM THREE-FLUTED RADIOLUCENT DRILL BIT/NEEDLE POINT/145MM. THIS REPORT IS RELATED TO (B)(4) WHICH REPORTS THE RADIOLUCENT DRIVE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17260328 ↗
• MalfunctionMay 4, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6)2023, THE PATIENT UNDERWENT THE OPEN REDUCTION AND INTERNAL FIXATION (ORIF) SURGERY FOR TIBIAL SHAFT FRACTURE. DURING THE SURGERY, THREE(3) EVENT WAS REPORTED AS FOLLOWS. THE RADIO LUCENT IN QUESTION IDLED DUE TO STUCK OF THE DRILL BIT. IT TOOK A LONG TIME TO DRILL BECAUSE IT WAS IN AN IDLING STATE WITH A LITTLE RESISTANCE. THERE WAS INTERFERENCE BETWEEN THE TNA NAIL IN QUESTION AND THE DRILL BIT ON THE PROXIMAL ML STATIC 1 HOLE. WHEN THE SURGEON PERFORMED MANUAL DRILLING WHILE FORCIBLY APPLYING TENSION TO THE SLEEVE, IT WAS INSERTED WITHOUT ANY PROBLEMS. THE DEFLECTION OF THE NAIL SEEMED TO BE THE CAUSE OF THE INTERFERENCE. THE PROTECTION SLEEVE IN QUESTION WAS CRUSHED BY THE INTERNAL PRESSURE OF THE JOINT SURFACE WHEN THE PROTECTION SLEEVE WAS INSERTED BETWEEN THE PATELLA AND KNEE JOINT SURFACE TO INSERT THE TNA NAIL IN THE SUPRA PATERA APPROACH. PROCEDURE WAS COMPLETED BY THE SURGEON'S FORCED USE OF GUIDEWIRE SLEEVES, CANNULATED DRILLS, AND FLEXIBLE REAMERS, WITH A FORTY (40) MINUTES SURGICAL DELAY. THE PROTECTION SLEEVE SEEMS WEAK. NO FURTHER INFORMATION IS AVAILABLE. THIS REPOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16868295 ↗
• MalfunctionJan 25, 2023Break; Contamination /Decontamination Problem; Break; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT ORIF FOR FRACTURE OF THE THIGH BONE TRUNK WITH THE PRODUCTS IN QUESTION. THE SURGEON COMMENTED THAT BLACK DEBRIS-LIKE MATERIAL FLEW INTO THE SURGICAL FIELD WHILE DRILLING A DISTAL AP HOLE USING A RADIOLUCENT. AFTER THE DRILL WAS COMPLETED, WHEN THE MAIN BODY OF RADIO LUCENT IN QUESTION AND THE DRILL TIP IN QUESTION WERE REMOVED, BLACK SHAVINGS WERE FOUND AT THE DRILL CONNECTION. IT WAS ALSO ADHERED TO THE WHITE PLASTIC PART OF THE DRILL. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. IN THE SURGEON'S OPINION, THE MAIN BODY OF THE RADIOLUCENT MAY HAVE BEEN WORN DOWN AND CARBON-LIKE DEBRIS MAY HAVE APPEARED. THE SURGEON HAS REQUESTED AN INVESTIGATION OF BLACK DEBRIS-LIKE MATERIAL. THERE ARE NO PIECES IN THE PATIENT. REMARKS: THIS (B)(4) AND (B)(4) ARE INVOLVED WITH THE SAME EVENT. (B)(4) (SYNTHES): DRILL BIT. (B)(4) (PTS): RADIOLUCENT-DRIVE. THIS REPORT IS FOR ONE (1) DRILL BIT Ø4.2 CALIBR L145 3FLUTE W/COUP. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16241219 ↗
• InjurySep 12, 2022Entrapment of Device; Failure to Cut; Entrapment of Device; Failure to Cut

  DEVICE REPORT FROM UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE DRILL BIT IN QUESTION WAS BLUNT AND THEN BROKE INSIDE OF THE PATIENT DURING DISTAL LOCKING. THE DISTAL FRAGMENT REMAINED IN THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 4.2 MM THREE-FLUTED RADIOLUCENT DRILL BIT/NEEDLE POINT/145 MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 15402512 ↗
• InjuryApr 29, 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) 2022, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION WITH THE ETN FOR THE FRACTURE OF THE DIAPHYSEAL TIBIA. DURING DRILLING FOR A DISTAL LOCKING SCREW WITH THE RADIOLUCENT DRIVE, THE DRILL BIT PENETRATED THE CONTRALATERAL CORTICAL BONE AND PROTRUDED OUT OF THE BODY. THE DRILL BIT PENETRATED THE SURGICAL MATTRESS. THE TIP OF THE DRILL BIT WAS DETERMINED TO BE UNCLEAN, SO THAT THE SURGEON CUT OFF THE TIP OF THE DRILL BIT AND PULLED OUT THE REST OF THE DRILL BIT. ADEQUATE STERILIZATION AND DISINFECTION WERE CONDUCTED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICES REPORTED: UNK - SCREWS: NAIL DISTAL LOCKING (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1); UNK - NAIL INSERTION HANDLES: RADIOLUCENT (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1); UNK - NAILS: EXPERT TIBIAL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE DRILL BIT Ø4.2 CALIBR L145 3FLUTE W/COUP. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14252156 ↗
• InjuryFeb 23, 2022Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING AN UNKNOWN PROCEDURE, WHEN PERFORMING THE BONE DRILLING FOR THE PLACEMENT OF THE DISTAL PIN NAIL, THE DRILL BIT FRACTURED IN ITS PROXIMAL PART. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) 4.2MM THREE-FLUTED RADIOLUCENT DRILL BIT/NEEDLE POINT/145MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13587963 ↗