NA 03.010.100Recalls & reported problems

Summary

The FDA's MAUDE database contains 58 adverse event reports that list this exact device (DI 10886982067661), received between May 16, 2017 and May 27, 2026 — classified as 8 injuries, 50 malfunctions.

The most frequently reported specific device problem is “Failure to Cut” (35 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 58 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 27, 2026Break; Material Twisted/Bent

  IT WAS REPORTED THAT WHEN USING AN ORTHOKIT (INSTRUMENT SET MULTILOC HUMERAL NAIL), IT WAS FOUND THAT THE DRILL BIT 3.2 CALIBR L145 3STE IS DAMAGED. THE TIP IS BROKEN DOWN AND THE DRILLING WINDINGS ARE TWISTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25306325 ↗
• MalfunctionJun 18, 2025Break; Entrapment of Device; Device-Device Incompatibility; Break; Entrapment of Device; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT INTRAMEDULLARY NAILING SURGERY WITH THE DRILL BIT. WHEN PRE-DRILLING THE DISTAL PART OF AN INTRAMEDULLARY NAIL, THE DRILL BIT, WHICH HAD BEEN OPENED AND STERILE, INTERFERED WITH THE NAIL, CAUSING THE PROTRUSION AT THE TIP OF THE DRILL TO BREAK. ALTHOUGH THE FRAGMENT OF THE DRILL BIT REMAINED IN THE BODY, BUT IT COULD NOT BE REMOVED, AND THE AMOUNT WAS SO SMALL THAT IT IS UNLIKELY TO CAUSE ANY HEALTH DAMAGE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 22284265 ↗
• MalfunctionFeb 10, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY VIA MHN LONG WITH THE PRODUCTS IN QUESTION. IN THE SURGERY, DURING DRILLING AT DISTAL USING A RADIOLUCENT DRIVE, THE NAIL AND THE DRILL BIT INTERFERED. WHEN ATTEMPTING TO MANIPULATE THE RADIOLUCENT DRIVE SO THAT ONLY THE DRILL BIT WAS LEFT TO PASS THROUGH, ABOUT 1 MM OF THE TIP OF THE DRILL BIT BROKE OFF AND REMAINED IN THE BODY. THE FRAGMENT WAS NOT REMOVED BY THE SURGEON'S DECISION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 30 MINUTES SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 21344245 ↗
• MalfunctionNov 14, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT OSTEOSYNTHESIS FOR A HUMERAL DIAPHYSEAL FRACTURE WITH THE NAIL AND THE DRILL BIT IN QUESTION. IN THE SURGERY, AFTER PROXIMAL FIXATION WITH MHNLONG 9.5-210 MM, WHILE DRILLING DISTALLY WITH RADIOLUCENT, THE DRILL BIT WAS NOT SHARP ENOUGH AND THE DRILL WAS DRILLED UNDER UNSTABLE CONDITIONS (FLOATING), SO IT COULD NOT BE CONTROLLED WELL, AND THE HOLE WAS DRILLED AT A SLIGHTLY OFF POSITION. THEN, THE FRACTURE OCCURRED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH 30 MINUTES OF SURGICAL DELAY. THE PATIENT OUTCOME WAS REPORTED TO BE STABLE. AFTER THE SURGERY, THE SURGEON COMMENTED THE FOLLOWING: - ONE OF THE FACTORS MAY BE THAT THE DRILL BIT WAS WORN OUT AND COULD NOT CUT. - THE 9.5MM THICK NAIL MAY HAVE CAUSED THE BONE TO BE DIRECTLY LOADED DUE TO THE LACK OF CLEARANCE (ESCAPE ROUTE). ONE POSSIBLE CAUSE OTHER THAN THE PRODUCT WAS THAT THE COUNTER COULD NOT BE APPLIED UNDER UNSTABLE CONDITIONS IN THE DISTAL UPPER ARM, MAKING IT DIFFICULT TO DRILL PROPERLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 20683080 ↗
• MalfunctionSep 13, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN ORIF WITH THE DRILL BITS IN QUESTION. THE DRILL BITS WERE NOT SHARP ENOUGH. ALL THE DRILL BITS IN THE INSTRUMENT SET WERE NOT SHARP ENOUGH, AND THE SURGEON COMMENTED THAT HE WAS AFRAID TO DRILL. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20211258 ↗
• MalfunctionSep 13, 2024Failure to Cut; Failure to Cut

  IT WAS REPORTED THAT ON AUGUST 26, 2024, THE PATIENT UNDERWENT AN ORIF WITH THE DRILL BITS IN QUESTION. THE DRILL BITS WERE NOT SHARP ENOUGH. ALL THE DRILL BITS IN THE INSTRUMENT SET WERE NOT SHARP ENOUGH, AND THE SURGEON COMMENTED THAT HE WAS AFRAID TO DRILL. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20211234 ↗
• MalfunctionOct 19, 2023Failure to Cut; Failure to Cut

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT ORIF SURGERY FOR HUMERAL SHAFT FRACTURE WITH THE DRILL BIT IN QUESTION. THE SURGEON POINTED OUT THAT THE DRILL BIT WAS NOT SHARP ENOUGH WHEN USED DURING SURGERY. BECAUSE THE PATIENT'S BONE QUALITY WAS GOOD, DRILLING TOOK SOME TIME. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A 3.2MM THREE-FLUTED RADIOLUCENT DRILL BIT/NEEDLE POINT/145MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17967676 ↗
• MalfunctionJun 23, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: THIS PC IS RELATED TO (B)(4) REPORTS ABOUT THE RADIOLUCENT DRIVE. THIS PC REPORTS ABOUT DRILL BIT AND MULTILOC HUMERAL NAIL. IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT ORIF SURGERY FOR FRACTURE OF THE PROXIMAL HUMERUS WITH RADIOLUCENT DRIVE, DRILL BIT AND MULTILOC HUMERAL NAIL. WHEN ATTEMPTING TO DRILL WITH THE RADIOLUCENT DRIVE TO INSERT A DISTAL LATERAL LOCKING SCREW INTO THE NAIL, IT WAS STUCK AND SPINNING DURING THE FIRST DRILL, MAKING IT UNUSABLE. THE SURGEON REQUESTED TO KNOW THE CAUSE OF THE PROBLEM, AS HE WAS AWARE THAT THE TORQUE WOULD CAUSE IT TO GET STUCK AT SOME POINT, BUT IN THIS CASE, IT STUCK WITH LITTLE RESISTANCE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. PATIENT OUTCOME AND STATUS WAS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) DRILL BIT Ø3.2 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 17190113 ↗
• MalfunctionJun 1, 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 ORIF SURGERY FOR HUMERUS FRACTURE WITH DRILL BIT. THE PATIENT WAS AN 89-YEAR-OLD MALE, BUT NEITHER OF THE TWO DRILL BITS WERE CUT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) DRILL BIT Ø3.2 CALIBR L145 3FLUTE W/COUP. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17042748 ↗
• MalfunctionJun 1, 2023Failure to Cut; Failure to Cut

  HOLD KV 6/12/23 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 HUMERUS FRACTURE WITH DRILL BIT. THE PATIENT WAS AN 89-YEAR-OLD MALE, BUT NEITHER OF THE TWO DRILL BITS WERE CUT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) DRILL BIT Ø3.2 CALIBR L145 3FLUTE W/COUP. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17042600 ↗
• MalfunctionApr 12, 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 AN ORIF SURGERY WITH A MHN LONG NAIL TREATING HUMERAL SHAFT. IT WAS DISCOVERED THAT THE DRILL BITS IN QUESTION WERE NOT SHARP ENOUGH WHEN THE SURGEON DRILLED WITH THEM. THE DRILL BITS WERE USED FOR DRILLING 2 DIFFERENT SCREW HOLES EACH, BUT BOTH DRILL BITS WERE NOT SHARP ENOUGH FOR USE. SURGERY WAS SUCCESSFULLY COMPLETED WITHIN A 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) DRILL BIT Ø3.2 CALIBR L145 3FLUTE W/COUP. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16728705 ↗
• MalfunctionApr 12, 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 AN ORIF SURGERY WITH A MHN LONG NAIL TREATING HUMERAL SHAFT. IT WAS DISCOVERED THAT THE DRILL BITS IN QUESTION WERE NOT SHARP ENOUGH WHEN THE SURGEON DRILLED WITH THEM. THE DRILL BITS WERE USED FOR DRILLING 2 DIFFERENT SCREW HOLES EACH, BUT BOTH DRILL BITS WERE NOT SHARP ENOUGH FOR USE. SURGERY WAS SUCCESSFULLY COMPLETED WITHIN A 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) DRILL BIT Ø3.2 CALIBR L145 3FLUTE W/COUP. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16728704 ↗
• MalfunctionJan 23, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2022, THE DRILL BIT TIP BROKE DURING DISTAL LOCK DRILLING. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 3.2MM 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 16223445 ↗
• MalfunctionDec 13, 2022Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT UNDERWENT A MULTILOC HUMERAL NAILING OPERATION. ON (B)(6) 2022, IT WAS NOTED THAT THERE WAS POOR SHARPNESS DURING DRILLING PRIOR TO INSERTION OF THE DISTAL TRANSVERSE STOP. THE SURGEON COMMENTED THAT HE HAD TRIED TWO DRILL BITS AND BOTH WERE NOT SHARP ENOUGH. IT WAS NOTED THE PATIENT STATUS WAS REPORTED AS STABLE. THIS REPORT IS FOR A DRILL BIT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15969199 ↗
• MalfunctionDec 13, 2022Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT UNDERWENT A MULTILOC HUMERAL NAILING OPERATION. ON (B)(6) 2022, IT WAS NOTED THAT THERE WAS POOR SHARPNESS DURING DRILLING PRIOR TO INSERTION OF THE DISTAL TRANSVERSE STOP. THE SURGEON COMMENTED THAT HE HAD TRIED TWO DRILL BITS AND BOTH WERE NOT SHARP ENOUGH. IT WAS NOTED THE PATIENT STATUS WAS REPORTED AS STABLE. THIS REPORT IS FOR A DRILL BIT. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15969127 ↗
• MalfunctionSep 30, 2022Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT A SURGERY FOR THE HUMERUS WITH THE DRILL BIT. THE SURGEON MENTIONED THAT THE DRILL WAS TOO DULL. THE SURGEON STRONGLY SUGGESTED THAT IT HAPPENED NOT ONLY THIS TIME, BUT WAS ALWAYS DULL. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A 30 MINUTE DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 3.2MM THREE-FLUTED RADIOLUCENT DRILL BIT/NEEDLE POINT/145MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15512063 ↗
• MalfunctionSep 30, 2022Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON SEPTEMBER (B)(6) 2022, THE PATIENT UNDERWENT A SURGERY FOR THE HUMERUS WITH THE DRILL BIT. THE SURGEON MENTIONED THAT THE DRILL WAS TOO DULL. THE SURGEON STRONGLY SUGGESTED THAT IT HAPPENED NOT ONLY THIS TIME, BUT WAS ALWAYS DULL. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A 30 MINUTE DELAY. THIS REPORT INVOLVES ONE 3.2MM THREE-FLUTED RADIOLUCENT DRILL BIT/NEEDLE POINT/145MM. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15511975 ↗
• MalfunctionJul 18, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT A SURGERY. WHEN THE SURGEON WAS DRILLING A SCREW HOLE AT MOST PROXIMAL OF THE DISTAL SCREW HOLES OF A MHN LONG NAIL WITH THE DRILL BIT IN QUESTION, THE DRILL BIT INTERFERED WITH THE NAIL AND THE TIP OF THE DRILL BIT BROKE. THE BROKEN TIP OF THE DRILL BIT WAS REMOVED FROM THE PATIENT¿S BODY SUCCESSFULLY. THIS WAS CONFIRMED BY X-RAY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: UNK - NAILS (PART# UNKNOWN; LOT# UNKNOWN). THIS IS REPORT 1 OF 1 FOR (B)(4) THIS REPORT IS FOR A DRILL BIT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15040879 ↗
• MalfunctionJan 4, 2022Failure to Cut; Failure to Cut

  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 RIGHT HUMERAL DIAPHYSEAL FRACTURE. DURING THE DISTAL SCREW INSERTION, THE DRILL BIT WAS DULL, AND IT TOOK A TIME TO PERFORM DRILLING. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT CONDITION IS STABLE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 3.2MM THREE-FLUTED RADIOLUCENT DRILL BIT/NEEDLE POINT/ 145MM. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13154426 ↗
• MalfunctionDec 3, 2021Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION SURGERY FOR FRACTURE OF PROXIMAL END OF HUMERUS. BONE QUALITY OF THE PATIENT WAS AGE-APPROPRIATE BUT COULD NOT BE DRILLED WITH THE DRILL BITS IN QUESTION. THE SURGEON POINTED OUT THAT THE POWER OF COLIBRI II ITSELF SEEMED TO BE ALSO EXTREMELY INSUFFICIENT, BUT MOST OF ALL, THE REASON WHY THE DRILL BITS COULD NOT DRILL BONES WAS PROBABLY BECAUSE THEY HAD VERY POOR SHARPNESS SINCE THEY WERE THE TYPE OF PRODUCT USED MULTIPLE TIMES. ANOTHER MANUAL DRILL WAS USED IN THE SURGERY, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN THIRTY (30) MINUTES SURGICAL DELAY. PATIENT OUTCOME IS REPORTED AS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR (1) 3.2MM THREE-FLUTED RADIOLUCENT DRILL BIT/NEEDLE POINT/145MM THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12925634 ↗
• MalfunctionDec 3, 2021Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION SURGERY FOR FRACTURE OF PROXIMAL END OF HUMERUS. BONE QUALITY OF THE PATIENT WAS AGE-APPROPRIATE BUT COULD NOT BE DRILLED WITH THE DRILL BITS IN QUESTION. THE SURGEON POINTED OUT THAT THE POWER OF COLIBRI II ITSELF SEEMED TO BE ALSO EXTREMELY INSUFFICIENT, BUT MOST OF ALL, THE REASON WHY THE DRILL BITS COULD NOT DRILL BONES WAS PROBABLY BECAUSE THEY HAD VERY POOR SHARPNESS SINCE THEY WERE THE TYPE OF PRODUCT USED MULTIPLE TIMES. ANOTHER MANUAL DRILL WAS USED IN THE SURGERY, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN THIRTY (30) MINUTES SURGICAL DELAY. PATIENT OUTCOME IS REPORTED AS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR (1) 3.2MM THREE-FLUTED RADIOLUCENT DRILL BIT/NEEDLE POINT/145MM. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12925632 ↗
• MalfunctionNov 23, 2021Failure to Cut; Failure to Cut

  THE PATIENT OUTCOME WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12862270 ↗
• MalfunctionNov 23, 2021Failure to Cut; Failure to Cut

  THE PATIENT OUTCOME WAS REPORTED AS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12862268 ↗
• MalfunctionJul 22, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT SURGERY FOR HUMERAL DIAPHYSIS. THE SURGEON TRIED TO DRILL THE BONE TO INSERT A SCREW. WHEN THE SURGEON WAS DRILLING WITH THE DRILL BIT ATTACHED TO THE RADIOLUCENT DRIVE, A STRONG RESISTANCE WAS FELT BUT THE SURGEON CONTINUED DRILLING. THE DRILL BIT BEGAN TO IDLE ROTATION AND STOPPED ROTATING. THE SURGEON USED A GUIDE WIRE INSTEAD AND INSERTED A SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A 20 TO 30 MINUTE SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 3.2MM THREE-FLUTED RADIOLUCENT DRILL BIT/NEEDLE POINT/145MM THIS IS REPORT 2 OF 2 FOR (B)(4).THIS PC IS RELATED TO (B)(4). THIS PC REPORTS ABOUT SYNTHES PRODUCTS (03.010.100) IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12212761 ↗
• MalfunctionJul 22, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT SURGERY FOR HUMERAL DIAPHYSIS. THE SURGEON TRIED TO DRILL THE BONE TO INSERT A SCREW. WHEN THE SURGEON WAS DRILLING WITH THE DRILL BIT ATTACHED TO THE RADIOLUCENT DRIVE, A STRONG RESISTANCE WAS FELT BUT THE SURGEON CONTINUED DRILLING. THE DRILL BIT BEGAN TO IDLE ROTATION AND STOPPED ROTATING. THE SURGEON USED A GUIDE WIRE INSTEAD AND INSERTED A SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH A 20 TO 30 MINUTE SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 3.2MM THREE-FLUTED RADIOLUCENT DRILL BIT/NEEDLE POINT/145MM THIS IS REPORT 1 OF 2 FOR (B)(4). THIS PC IS RELATED TO (B)(4). THIS PC REPORTS ABOUT SYNTHES PRODUCTS (03.010.100) IN THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12212743 ↗