NA 03.130.200Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 10886982075314), received between Apr 28, 2017 and Mar 18, 2026 — classified as 12 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Break” (36 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 18, 2026Failure to Cut; Material Deformation

  DURING SURGERY, IT WAS NOTED THAT THE IDENTIFIED DRILL BITS LISTED IN THIS COMPLAINT WERE DULL AND WERE NO LONGER FUNCTIONING TO THEIR OPTIMAL DRILLING CAPACITY. THESE COMPONENTS WERE DEEMED TO BE NO LONGER FUNCTIONAL, AND WERE SUBSEQUENTLY DISCARDED. REPLACEMENTS ARE REQUIRED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24627414 ↗
• MalfunctionDec 9, 2025Break; Break

  DURING A PROCEDURE, THE TIPS OF TWO (2) DRILL BITS BROKE WHILE DRILLING. THE FRAGMENTS WERE COMPLETELY REMOVED EACH TIME, AND REPLACEMENT DRILL BITS FROM THE KIT WERE USED TO CONTINUE THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY, THERE WERE NO ADVERSE EFFECTS ON THE PATIENT, AND THE SURGICAL SCHEDULE WAS NOT ALTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23757298 ↗
• MalfunctionJun 20, 2025Break; Break

  IT WAS REPORTED THAT THE SURGEON LOADED THE DRILL BIT INTO THE POWER TOOL. WHEN PERFORMING THE ROUTINE CHECK TO CONFIRM THE DRILL BIT DOES NOT SPIN OFF AXIS, THE DRILL BIT SHEARED INTO TWO PIECES. THIS TEST IS ROUTINELY PERFORMED BY SURGEONS BEFORE DRILLING INTO BONE. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22301418 ↗
• MalfunctionApr 17, 2025Break; Break

  DURING THE SURGICAL PROCEDURE, THE MOTOR FROM THE COMMERCIAL COMPANY JNJ FAILS, THE MOTOR IS CHANGED AND WHEN STARTING TO DRILL THE CHANNEL TO PASS A SCREW, THE DRILL BREAKS.

  Patient problems: Insufficient Information

  MAUDE report 21859309 ↗
• MalfunctionOct 14, 2024Break; Break

  DURING THE SURGERY, AT THE MOMENT THE SPECIALIST PERFORMS THE BROCADE, THE 1.1 DRILL BIT BROKE. IMMEDIATELY THE SPLIT DRILL BIT AND ITS FRAGMENTS WERE REMOVED AND THE SPECIALIST WAS GIVEN A NEW DRILL BIT OF THE SAME CHARACTERISTICS. THERE WERE NO ISSUES WITH THE SPECIALIST, THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT AFFECTING THE PATIENT AND WITHOUT ALTERATIONS IN THE SURGICAL TIMES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20441451 ↗
• MalfunctionApr 2, 2024Failure to Cut; Failure to Cut

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT DURING THE SURGERY ON (B)(6) 2024, IT WAS IDENTIFIED THAT THE DRILLS OF THE 1.5 SYSTEM WERE DAMAGED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 1.1MM DRILL BIT/K-WIRE ATTCHMT FOR THREADED HOLE/70MM THIS IS REPORT 6 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19024023 ↗
• MalfunctionApr 2, 2024Failure to Cut; Failure to Cut

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT DURING THE SURGERY ON (B)(6) 2024, IT WAS IDENTIFIED THAT THE DRILLS OF THE 1.5 SYSTEM WERE DAMAGED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND THERE WAS NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) 1.1MM DRILL BIT/K-WIRE ATTCHMT FOR THREADED HOLE/70MM. THIS IS REPORT 4 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19020742 ↗
• MalfunctionJun 20, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2023, THE MATERIAL WAS DAMAGED (SPLIT). THIS REPORT INVOLVES ONE 1.1MM DRILL BIT/K-WIRE ATTCHMT FOR THREADED HOLE/70MM. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17162640 ↗
• MalfunctionJun 14, 2023Break; Break

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, A DRILL BIT WAS RECEIVED IN LOCAL STOCK, MARKED WITH RED TAPE. UPON MANUFACTURER INVESTIGATION, IT WAS DETERMINED THAT THE TIP OF THE DRILL BIT Ø1.1 L70/39 F/CORE HOLE WAS BROKEN AND MISSING. THIS REPORT IS FOR A 1.1MM DRILL BIT/K-WIRE ATTCHMT FOR THREADED HOLE/70MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17127568 ↗
• MalfunctionMar 16, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, AT THE TIME OF STARTING THE SURGERY AND TRYING TO BROACH, THE DRILL BIT BROKE. THERE WAS NO DELAY IN SURGERY, THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION. THIS REPORT INVOLVES ONE 1.1MM DRILL BIT/K-WIRE ATTCHMT FOR THREADED HOLE/70MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16552138 ↗
• 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 1.1 DRILL BIT BROKE WHILE THE BONE WAS DRILLED. THERE WAS A FIVE-MINUTE DELAY IN RELATION TO THE EVENT. THE SURGERY WAS COMPLETED SUCCESSFULLY, AND NO BROKEN FRAGMENTS WERE RETAINED IN THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 1.1MM DRILL BIT/K-WIRE ATTCHMT FOR THREADED HOLE/70MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16223924 ↗
• InjuryDec 8, 2022Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON WAS FIXING A BROKEN FINGER AND THE DRILL BIT BROKE, AND A PORTION WAS LEFT IN THE PATIENT. THE PATIENT HAD SUPER HARD BONE. THE PIECE WAS NOT REMOVED AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE 1.1MM DRILL BIT/K-WIRE ATTACHMENT FOR THREADED HOLE/70MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 15945527 ↗
• MalfunctionOct 20, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION WITH THE DRILL BITS AND THE SCREWS FOR THE COMMINUTED FRACTURE OF THE PROXIMAL PHALANX AND THE INDEX PROXIMAL PHALANX. WHEN THE SURGEON DRILLED TO THE PLATE WITHOUT A DRILL SLEEVE, THE TIP OF THE DRILL BIT BROKE AND REMAINED IN THE PATIENT¿S BODY. IT TOOK APPROXIMATELY 30 MINUTES TO REMOVE THE BROKEN TIP. THE SURGEON DRILLED WITH A NEW DRILL BIT AND A DRILL SLEEVE, AND THE TIP OF THE DRILL BIT BROKE AND REMAINED IN THE PATIENT¿S BODY AGAIN. IT TOOK MORE THAN 30 MINUTES. BOTH DRILLS WERE BROKEN AT THE BORDER OF THE FLUTE. IT WAS CONFIRMED BY X-RAYS THAT THERE WERE NO BROKEN PIECES IN THE PATIENT¿S BODY. IN ADDITION, WHEN THE SURGEON WAS INSERTING THE SCREWS, THE SCREWS STOPPED IN THE MIDDLE OF THE ROAD DUE TO WRONG DIRECTION. ALTHOUGH THE SURGEON REMOVED THE SCREWS AND RE-INSERTED THEM SEVERAL TIMES, THE SCREW HEADS BROKE AND COULD NOT BE REMOVED. THEREFORE, THE SURGEON REMOVED THE SCREWS WITH A PLIER. IT WAS CONFIRMED BY X-RAYS THAT THERE WERE NO BROKEN SCREWS IN THE PATIENT¿S BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15640154 ↗
• MalfunctionOct 20, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION WITH THE DRILL BITS AND THE SCREWS FOR THE COMMINUTED FRACTURE OF THE PROXIMAL PHALANX AND THE INDEX PROXIMAL PHALANX. WHEN THE SURGEON DRILLED TO THE PLATE WITHOUT A DRILL SLEEVE, THE TIP OF THE DRILL BIT BROKE AND REMAINED IN THE PATIENT¿S BODY. IT TOOK APPROXIMATELY 30 MINUTES TO REMOVE THE BROKEN TIP. THE SURGEON DRILLED WITH A NEW DRILL BIT AND A DRILL SLEEVE, AND THE TIP OF THE DRILL BIT BROKE AND REMAINED IN THE PATIENT¿S BODY AGAIN. IT TOOK MORE THAN 30 MINUTES. BOTH DRILLS WERE BROKEN AT THE BORDER OF THE FLUTE. IT WAS CONFIRMED BY X-RAYS THAT THERE WERE NO BROKEN PIECES IN THE PATIENT¿S BODY. IN ADDITION, WHEN THE SURGEON WAS INSERTING THE SCREWS, THE SCREWS STOPPED IN THE MIDDLE OF THE ROAD DUE TO WRONG DIRECTION. ALTHOUGH THE SURGEON REMOVED THE SCREWS AND RE-INSERTED THEM SEVERAL TIMES, THE SCREW HEADS BROKE AND COULD NOT BE REMOVED. THEREFORE, THE SURGEON REMOVED THE SCREWS WITH A PLIER. IT WAS CONFIRMED BY X-RAYS THAT THERE WERE NO BROKEN SCREWS IN THE PATIENT¿S BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15640019 ↗
• MalfunctionJul 13, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THE DRILL BIT AND SCREW BROKE DURING INSERTION. THE SCREW REMAINING LEFT IN BONE. THE DRILL BIT REMAINING WAS REMOVED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THIS REPORT IS FOR ONE (1) 1.5 CORTEX SCREW SLF-TPNG T4 SD REC 24. THIS IS REPORT 1 OF 2 FOR COMPLAINT: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15007940 ↗
• MalfunctionJun 6, 2022Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT A DRILL BIT BROKE DURING A SURGERY ON (B)(6) 2022. THERE WAS NO SURGICAL DELAY. PATIENT OUTCOME IS REPORTED AS OKAY. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 1.1MM DRILL BIT/K-WIRE ATTCHMT FOR THREADED HOLE/70MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14599888 ↗
• MalfunctionApr 19, 2022Failure to Cut; Failure to Cut

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6), 2022, THE 0.8 L 40/16 DRILL BIT SPLIT AND THE 1.1 L 70/39 DRILL BIT WAS NOT CUTTING. PROCEDURE WAS SUCCESSFUL. THE PROCEDURE WAS NOT DELAYED BY THIS EVENT. THERE WAS NO OTHER MEDICAL INTERVENTION REQUIRED. PATIENT OUTCOME IS REPORTED AS OKAY. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) 1.1MM DRILL BIT/K-WIRE ATTCHMT FOR THREADED HOLE/70MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14146692 ↗
• InjuryMar 29, 2022Entrapment of Device; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DR. (B)(6) WAS PERFORMING AN ORIF OF THE LEFT 4TH METACARPAL. USING THE SYNTHES VA LOCKING HAND SYSTEM (1.5MM MODULE). DR. (B)(6) USED THE 1.1MM DRILL BIT TO PERFORM A 1.5MM LAG SCREW, BUT WAS UNSUCCESSFUL. IT WAS THEN DETERMINED THAT HE WOULD JUST PLATE AND SCREW THE FRACTURE. AFTER HAVING CONTINUED DIFFICULTY WITH THE 1.1 DRILL BIT, DR. (B)(6) OPTED TO SWITCH TO THE 2.0MM MODULE AND THE 1.5MM DRILL. DURING FINAL FILMS, IT WAS DISCOVERED THAT THE TIP OF THE 1.1MM DRILL BIT, USED FOR THE ATTEMPTED LAG SCREW, HAD BROKEN OFF IN THE CANAL OF THE PATIENTS FINGER. UNNOTICED BY THE DOCTOR, OR STAFF, OR MYSELF PRIOR TO FINAL FILMS. DR. (B)(6) CHOSE TO LEAVE THE TIP OF THE DRILL IMPLANTED AS HE FELT THE RISK OF LOSING REDUCTION AND THE ABILITY TO FIX THE FRACTURE OUTWEIGHED LEAVING THE STERILE TIP IMPLANTED. THIS COMPLAINTS INVOLVES ONE (1) DEVICE DRILL BIT Ø1.1 L70/39 F/CORE HOLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 13938544 ↗
• MalfunctionNov 30, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, THE DRILL BIT BROKE AND FLEW OUT OF THE HANDPIECE WHILE THE SCRUB TECH WAS HOLDING IT TO CLEAN IT. SCRUB TECH ACCIDENTALLY TURNED ON THE DRILL AND IT'S A HIGH-SPEED HANDPIECE. THERE WAS NO DRILL GUIDE ATTACHED AT THE TIME CAUSING THE DRILL BIT TO SPIN RAPIDLY AND BEND, WHICH CAUSED THE DRILL BIT TO BREAK. IT THEN EJECTED FROM THE HANDPIECE, HIT THE OVERHEAD LIGHT FIXTURE ABOVE THE PATIENT, RICOCHETED OFF THERE, AND HIT MY HEAD. THE PUNCTURE IN MY SCALP IS THE DIAMETER OF THE DRILL BIT, 1.1 MM. PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: UNK - DRILL (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY#:1 ). UNK - POWERED DRIVERS/HANDPIECES (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY#:1). THIS REPORT IS FOR ONE (1) 1.1 DRILL BIT/K-WIRE ATTCHMT THRD H/70. (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12899105 ↗
• MalfunctionSep 24, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, THE DRILL BIT BROKE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. IT IS UNKNOWN IF THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES (1) DEVICE. THIS REPORT IS FOR (1) 1.5MM DRILL BIT/QC/110MM. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12525802 ↗
• MalfunctionJun 15, 2021Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A FRACTURE OCCURRED DURING SURGERY. THIS REPORT IS FOR ONE (1) 1.1MM DRILL BIT/K-WIRE ATTCHMT FOR THREADED HOLE/70MM. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11999988 ↗
• MalfunctionJun 8, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, THE DRILL BIT OF 1.1 WAS BROKEN AT THE TIME OF WASHING THE MATERIAL. THE POSTOPERATIVE RADIOGRAPHS ARE REVIEWED WITH THE RESIDENT BUT THERE IS NO EVIDENCE THAT THE PIECE IS INSIDE THE PATIENT, POSSIBLY IT BROKE AT THE END. THIS REPORT IS FOR ONE (1) 1.1MM DRILL BIT/K-WIRE ATTCHMT FOR THREADED HOLE/70MM. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11957976 ↗
• MalfunctionJul 7, 2020Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2020, TWO (2) UNKNOWN DEVICES WITH PART NUMBER 03.132.010 WERE BROKEN OR TWISTED, WHILE THREE (3) OTHER 1MM DRILL BIT WERE ALSO BROKEN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS AND SURGICAL OUTCOME WERE UNKNOWN. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR ONE (1) 1.1MM DRILL BIT/K-WIRE ATTACHMENT FOR THREADED HOLE/70MM. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10240525 ↗
• MalfunctionJul 7, 2020Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2020, TWO (2) UNKNOWN DEVICES WITH PART NUMBER 03.132.010 WERE BROKEN OR TWISTED, WHILE THREE (3) OTHER 1MM DRILL BIT WERE ALSO BROKEN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS AND SURGICAL OUTCOME WERE UNKNOWN. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR ONE (1) 1.1MM DRILL BIT/K-WIRE ATTACHMENT FOR THREADED HOLE/70MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10240522 ↗
• MalfunctionJul 7, 2020Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2020, TWO (2) UNKNOWN DEVICES WITH PART NUMBER 03.132.010 WERE BROKEN OR TWISTED, WHILE THREE (3) OTHER 1MM DRILL BIT WERE ALSO BROKEN. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PATIENT STATUS AND SURGICAL OUTCOME WERE UNKNOWN. THIS COMPLAINT INVOLVES FIVE (5) DEVICES. THIS REPORT IS FOR ONE (1) 1.1MM DRILL BIT/K-WIRE ATTACHMENT FOR THREADED HOLE/70MM. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10240520 ↗