NA 03.168.011Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10886982274700), received between Jun 7, 2019 and Mar 2, 2026 — classified as 3 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 2, 2026Break

  THE DRILL BIT BROKE DURING FNS SURGERY. THERE WAS NO PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24489656 ↗
• MalfunctionFeb 18, 2026Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE DRILL BIT. THE DRILL WAS USED WHEN THE DISTAL LOCKING SLEEVE WAS NOT FULLY INSERTED AND THE OPENING WAS NARROW, SO IT RESISTED AND THE DRILL COULD NOT MOVE. THE DRILL HAD TO BE CAUGHT, WHICH CAUSED THE AO CHUCK PART TO BECOME DEFORMED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24378145 ↗
• MalfunctionAug 6, 2025Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material

  IT WAS REPORTED THAT ON (B)(6), 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE DRILL BIT. THE SURGEON TRIED TO ATTACH THE DRILL BIT TO A QUICK COUPLING (05.001.250) WHICH THE HOSPITAL OWNS, BUT IT WAS NOT ABLE TO DO IT. SO, A JACOBS CHUCK WAS USED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. AFTER THE SURGERY, THEY CHECKED THE DRILL BIT, AND IT WAS CONFIRMED THAT THERE WAS A DENT-LIKE SCRATCH AT THE BASE OF THE DRILL BIT, MAKING IT IMPOSSIBLE TO CONNECT TO THE ATTACHMENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22724870 ↗
• InjuryApr 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT FNS SURGERY FOR FEMORAL NECK FRACTURE WITH DRILL BIT FOR FNS ANTI ROTATION SCREW. THE SURGEON DIDN'T NOTICE THAT THE NURSE FORGOT TO SET THE SLEEVE FOR FIXING, AND THE SURGEON DRILLED FOR ANTI ROTATION SCREW. AS A RESULT, THE DRILL BIT BROKE THROUGH THE FEMORAL HEAD. THE DRILLING BIT REACHED OUTWARDS CURVATURE OF PELVIS AND SCRAPED ITS CARTILAGE SLIGHTLY. THE FIXING FEMORAL NECK FRACTURE SURGERY WITH FNS WAS COMPLETED SUCCESSFULLY. HOWEVER, THE SURGEON SUGGESTED THAT THE BREAKTHROUGH THE FEMORAL HEAD WILL CAUSE OA(OSTEOARTHRITIS) IN FUTURE. THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 21883024 ↗
• MalfunctionJan 2, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT DURING PRE-DRILLING FOR THE LOCKING SCREW IN THE FEMUR SHAFT DURING AN ORIF PROCEDURE, THE TIP OF THE DRILL BIT BROKE OFF IN THE FEMUR. THE DRILL BIT WAS SWITCHED OUT FOR A SUITABLE REPLACEMENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE FRAGMENT REMAINED IN THE PATIENT. SURGERY WAS DELAYED BY FIVE MINUTES DUE TO THE EVENT, AND THERE WAS NO PATIENT CONSEQUENCE. THE FRAGMENT REMAINED IN THE PATIENT AS SURGEON DETERMINED IT WOULD CAUSE NO ADVERSE EFFECT. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Foreign Body In Patient

  MAUDE report 21060521 ↗
• MalfunctionJun 28, 2024Break; Break

  IT WAS REPORTED DURING SURGERY ON (B)(6) 2024, WHEN THE DOCTOR USED THE DRILL BIT, THE TIP BROKE. THE FRAGMENT WAS REMOVED AND ANOTHER DRILL BIT USED. THE SURGERY ENDED SUCCESSFULLY, WITH NO AFFECTATION TO THE PATIENT, NOR ALTERATION IN THE SURGICAL TIMES. THERE WAS NO AFFECTATION TO THE PATIENT. THIS REPORT IS FOR DRILL BIT Ø4.3 L413 THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19638456 ↗
• MalfunctionFeb 14, 2024Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PARTS WERE DAMAGED DURING SURGERY. UPON INSPECTION OF THE RETURNED PRODUCTS ON (B)(6) 2024, IT WAS NOTED THAT THE TWO DRILL BIT Ø4.3 L413S WERE BROKEN. THIS REPORT INVOLVES ONE 4.3MM DRILL BIT LENGTH 413MM. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18701609 ↗
• MalfunctionFeb 14, 2024Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PARTS WERE DAMAGED DURING SURGERY. UPON INSPECTION OF THE RETURNED PRODUCTS ON (B)(6) 2024, IT WAS NOTED THAT THE TWO DRILL BIT Ø4.3 L413S WERE BROKEN. THIS REPORT INVOLVES ONE 4.3MM DRILL BIT LENGTH 413MM. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18701608 ↗
• MalfunctionJun 15, 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 RIGHT FEMORAL NECK FRACTURE WITH FNS DRILL BIT. DURING THE LATERAL LOCKING SCREW INSERTION PHASE, IT TOOK TIME TO REACH THE CONTRALATERAL CORTEX WHEN DRILLING. THE SURGEON POINTED OUT THAT THE DRILL BIT WAS NOT SHARP ENOUGH. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THIRTY(30) MINUTES OF SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 4.3MM DRILL BIT LENGTH 413MM. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17139577 ↗
• MalfunctionMay 24, 2023Material Discolored; Failure to Cut; Material Discolored; Failure to Cut

  THE SURGEON CONSIDERED THAT PATIENT HAD GOOD BONE QUALITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16991747 ↗
• MalfunctionJan 3, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN SWITZERLAND AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, IT WAS DISCOVERED THAT THE DRILL TIP WAS BROKEN, AND IT IS NOT KNOWN WHERE THE TIP IS. IT WAS DISCOVERED DURING THE NEXT OPERATION WHEN THE TABLE WAS BEING PREPARED. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 4.3MM DRILL BIT LENGTH 413MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16086536 ↗
• MalfunctionAug 22, 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 THE OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY FOR FEMORAL NECK FRACTURE. AFTER INSERTING A NECK BOLT AND A PLATE, THE SURGEON HAD A DIFFICULTY DRILLING THE CORTICAL BONE FOR INSERTING A LOCKING SCREW. ALTHOUGH SOFT TISSUE WAS NOT INVOLVED AT THE TIME OF THE DRILLING AND THE PATIENT'S CORTICAL BONE WAS NOT THICK BECAUSE HE/SHE WAS OLD, THE CORTICAL BONE COULD NOT BE PENETRATED BY THE DRILL EVEN AFTER A WHILE. THEREFORE, THE SURGEON COMMENTED THAT THE DRILL BIT WAS NOT SHARP ENOUGH. IT WAS UNKNOWN HOW FREQUENTLY THE DRILL BITS WERE INSPECTED AND REPLACED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN A THIRTY (30) MINUTE DELAY WITH NO ADDITIONAL MEDICAL INTERVENTION REQUIRED. THE PATIENT OUTCOME WAS REPORTED AS STABLE. THIS REPORT IS FOR A DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15265319 ↗
• InjuryMay 25, 2022Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED BY THE SALES REP CUSTOMER IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE TIP ON THE DRILL BIT DEVICE BROKE OFF INTO PATIENT'S FEMORAL HEAD AND COULD NOT BE RETRIEVED. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS COMPLAINT INVOLVES ONE DEVICE.

  Patient problems: Foreign Body In Patient

  MAUDE report 14498448 ↗
• MalfunctionApr 20, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS IS REPORT 3 OF 3 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT A PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION PROCEDURE FOR THE FRACTURE OF THE FEMORAL NECK ON (B)(6) 2022. IT WAS REPORTED THAT DURING REAMING BY FIVE MM MINUS TO THE MEASURED VALUE FOR A BOLT, THE REAMER DEVICE CUT OUT THE FEMORAL HEAD. ACCORDING TO THE SURGEON, THE BONE QUALITY WAS WEAKER THAN THE SURGEON EXPECTED, AND THE REAMER PUSHED FORWARD. IT WAS REPORTED THAT THE SURGEON DRILLED 90MM AND INSERTED THE ANTIROTATION-SCREW (90MM) AFTER CHECKING THE IMAGE WHEN THE STOPPER WAS ACTIVATED. HOWEVER, THE ANTIROTATION-SCREW WAS INSERTED ABOUT FIVE MM INSIDE OF THE DRILLING POSITION, SO THAT THE SURGEON REPLACED THE ANTIROTATION-SCREW (90MM) WITH THE ANTIROTAION-SCREW (85MM). THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGEON COMMENTED THAT HE WAS AWARE THAT THE POSITION OF THE DRILLING WAS SLIGHTLY SHORTER THAN THE ACTUAL IMPLANT; HOWEVER, THE ACTUAL IMPLANT WAS LONGER THAN HE HAD EXPECTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14159440 ↗
• MalfunctionDec 16, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2020, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION SURGERY FOR THE FEMORAL NECK MEDIAL FRACTURE WITH THE DRILL BIT AND SLEEVE IN QUESTION. DURING THE SCREW INSERTION, THE SURGEON TRIED TO ASSEMBLE THE DRILL BIT TO THE SLEEVE, BUT WHEN THE DRILL BIT WAS INSERTED TO THE SLEEVE HALFWAY, HE COULDN'T PUSH AND PULL THE DRILL BIT AND IT STUCK TO THE SLEEVE. THE SURGEON REMOVED THE DEVICES AND IMPLANTS ONCE, AND HE COULD DISSEMBLE THE DRILL BIT FROM THE SLEEVE. THE SURGEON TRIED TO ASSEMBLE THEM AGAIN OUT OF THE BODY, BUT HE COULDN'T, TOO. THE SURGEON CONTINUED THE SURGERY WITHOUT USING THE DRILL BIT AND SLEEVE AND THE SURGERY WAS COMPLETED SUCCESSFULLY. AFTER THE SURGERY WHEN THE SURGEON TRIED TO PASS THE DRILL BIT THROUGH THE SLEEVE, HE HAD DIFFICULTY IN ASSEMBLING THEM, BUT HE COULD PASS THE DRILL BIT THROUGH THE SLEEVE. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREW (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 1). THIS COMPLAINT INVOLVES TWO DEVICES. THIS REPORT IS FOR (1) DRILL BIT Ø4.3 L413. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11023225 ↗
• MalfunctionAug 24, 2020Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT THE ORIF SURGERY FOR FEMORAL NECK FRACTURES. DURING THE SURGERY, THE SURGEON FELT THE DRILL BIT WAS DULL WHEN DRILLING LATERALLY. HE HAD DIFFICULTY DRILLING BUT MANAGED TO DRILL UP TO THE CONTRALATERAL PART. HE OPENED THE PILOT HOLE BY USING A GUIDE WIRE AND DRILLED AGAIN. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A THIRTY (30) MINUTE DELAY. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICES REPORTED: UNKNOWN DRILL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). UNKNOWN GUIDE WIRE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 4.3MM DRILL BIT LENGTH 413MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10443389 ↗
• MalfunctionJan 28, 2020Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION SURGERY FOR FEMORAL NECK FRACTURE WITH THE DRILL BIT IN QUESTION. DURING THE SURGERY, THE DRILL BIT WAS DULL. THE SURGERY WAS DELAYED BY LESS THAN 30 MINUTES. IT WAS NOT REPORTED HOW THE SURGERY WAS FINISHED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 4.3MM DRILL BIT LENGTH 413MM THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9637560 ↗
• MalfunctionSep 3, 2019Failure to Align; Failure to Align

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION SURGERY FOR FEMORAL NECK FRACTURE WITH THE INSERTION HANDLE, THE INSERT, THE PROTECTION SLEEVE AND THE DRILL BIT IN QUESTION. WHEN THE SURGEON TRIED TO DRILL, THE DRILL BIT INTERFERED WITH OTHER DEVICES AND IT COULD NOT REACH TO A PLATE. THE SURGEON RE-ATTACHED THE PROTECTION SLEEVE TO THE DRILL BIT AND HE COULD DRILL SUCCESSFULLY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE SURGERY WAS DELAYED BY LESS THAN 30 MINUTES. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICES REPORTED: UNKNOWN PLATES (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1), UNK - POWERED DRIVERS/HANDPIECES: TRAUMA (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY#1). THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR ONE (1) 4.3MM DRILL BIT LENGTH 413MM. THIS REPORT IS 2 OF 4 FOR (B)(4).

  Patient problems: Not Applicable

  MAUDE report 8958039 ↗
• MalfunctionJul 22, 2019Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY FOR THE FEMORAL NECK FRACTURE WITH FEMORAL NECK SYSTEM (FNS). DURING THE PROCEDURE, WHILE THE SURGEON WAS DRILLING FOR THE LOCKING SCREW USING THE DRILL BIT, IT TOOK A LONGER TIME THAN USUAL. THE SURGEON HEARD A FRICTION SOUND AND CHECKED THE DEVICES AND X-RAYS, BUT THERE WERE NO PROBLEMS SUCH AS LOOSENING OF DEVICES. IT TOOK MORE THAN FIVE (5) MINUTES TO DRILL UNTIL CONTRALATERAL BONE, WHEREAS IT TAKES LESS THAN A MINUTE NORMALLY. DURING THE DRILLING, THE SURGEON PULLED OUT THE DRILL BIT TWO (2) TIMES AND REMOVED SOFT TISSUES WHICH ADHERED TO THE DRILL BIT. THE COLOR OF THE SOFT TISSUES HAD TURNED BLACK-RED. NO METAL POWDER WAS FOUND IN THE SOFT TISSUES. THE SURGEON MENTIONED THAT IT DIDN¿T SEEM THAT THE DRILL BIT INTERFERED WITH ANY METAL DEVICES. THE SURGEON COULD INSERT THE LOCKING SCREW AND COMPLETED THE SURGERY WITHOUT OTHER PROBLEMS. THERE WERE LESS THAN THIRTY (30) MINUTES OF SURGICAL DELAY. THE PATIENT OUTCOME IS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN LOCKING SCREW (PART# UNKNOWN, LOT# UNKNOWN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8813490 ↗
• InjuryJun 7, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN OSTEOSYNTHESIS SURGERY FOR FEMORAL NECK FRACTURES USING WITH A FEMORAL NECK SYSTEM (FNS), THE REAMER INTERFERED WITH THE PROTECTION SLEEVE AND AN UNKNOWN K-WIRE AND SYNTHES DRILL BIT BROKE. THE SURGEON CHECKED IF THERE WERE FRAGMENTS IN THE PATIENT'S BODY, BUT NO FRAGMENTS WERE FOUND INTRAOPERATIVELY. AFTER THE SURGERY, METAL DEBRIS WAS CONFIRMED ON LATERAL SIDE VIA X-RAYS. THE FRAGMENTS WILL BE REMOVED WHEN IMPLANTS WILL BE REMOVED IN THE FUTURE. THERE WAS NO SURGICAL DELAY. SURGICAL PROCEDURE OUTCOME AND PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE REPORTED: GUIDE WIRE (PART# 357.399S, LOT# 2L42266, QUANTITY 1), UNKNOWN K-WIRE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), UNKNOWN PROTECTION SLEEVE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 8679976 ↗