NA 03.010.228Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10886982068101), received between Mar 9, 2017 and Apr 27, 2026 — classified as 11 injuries, 15 malfunctions.

The most frequently reported specific device problem is “Break” (26 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2026Break

  DURING THE NAILING SURGERY WITH ALFN PRODUCT, THE DRILL BIT OF THE SET BROKE INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25002238 ↗
• MalfunctionNov 5, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED DURING THE SURGICAL PROCEDURE, THE DRILL BIT BROKE. THE PROCEDURE WAS EXTENDED FOR APPROXIMATELY THIRTY (30) MINUTES, BUT THE BROKEN PIECE COULD NOT BE REMOVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 23476061 ↗
• MalfunctionMar 22, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHEN THE SURGEON WAS DRILLING THE SCREW, THE TIP OF THE DRILL BIT BROKE OFF. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE DRILL BIT FOR 5.0MM RECON SCREWS/LARGE QC. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18958287 ↗
• MalfunctionMar 19, 2024Break; Entrapment of Device; Break; Entrapment of Device

  THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 18935763 ↗
• MalfunctionNov 16, 2023Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM COLOMBIA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2023, A SCREW WAS DRILLED TOWARDS THE FEMORAL NECK AND THE BIT BROKE. PART OF THE DRILL BIT WAS LEFT IN THE PATIENT, IT COULD NOT BE REMOVED. ADDITIONALLY, THE SHORT DRILL BIT WAS PASSED THROUGH FOR DISTAL BLOCKS AND BROKE AS WELL. THERE WAS NO REPORTED ADVERSE PATIENT IMPACT. NO FURTHER INFORMATION IS AVAILABLE TO REPORT. THIS REPORT IS FOR A DRILL BIT FOR 5.0MM RECON SCREWS/LARGE QC. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 18148626 ↗
• MalfunctionSep 15, 2023Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SURGEON WAS REPAIRING A MIDSHAFT FEMUR OF PATIENT. ADOLESCENT NAIL WAS CHOSEN FOR THE REPAIR. THE STANDARD ENTRY POINT WAS CHOSEN AND THE CANAL WAS OPENED WITH THE APPROPRIATE ENTRY REAMER. 2.5MM BALL TIP GUIDE WIRE WAS INSERTED AND FLEXIBLE REAMERS WERE USED TO A 12MM DIAMETER. SURGEON MEASURED FOR LENGTH AND A 10X400 MM LEFT ADOLESCENT NAIL WAS INSERTED TO THE PROPER DEPTH. GUIDE WIRES WERE INSERTED TO THE PROPER DEPTH IN BOTH RECON SCREW GUIDE SLEEVES. GUIDE WIRES WERE MEASURED FOR LENGTH. 90 MM RECON SCREWS WERE REQUESTED. SURGEON REMOVED FIRST GUIDE WIRE IN THE INFERIOR RECON SLEEVE AND DRILLED WITH RECON DRILL BIT. 90MM RECON SCREW WAS INSERTED TO THE CORRECT DEPTH. SECOND GUIDE WIRE WAS REMOVED AND DRILL BIT 03.010.228 WAS UTILIZED AGAIN. THE TIP OF THE DRILL BIT BROKE OFF IN THE NECK OF THE FEMUR. SURGEON CHOSE TO PLACE THE 90MM RECON SCREW 04.031.028, BUT THE FRAGMENT PUSHED THE SCREW TO SUPERIOR. A 50MM RECON SCREW WAS CHOSEN AND THE 90MM RECON SCREW WAS REMOVED. SURGEON DECIDED TO PLACE A 4MM TRANSVERSE SCREW AS WELL TO BOLSTER FIXATION DUE TO SHORT RECON SCREW USED. 15 MINUTES WERE ADDED TO THE CASE TO REPLACE 90MM RECON SCRE

  Patient problems: Insufficient Information

  MAUDE report 17755297 ↗
• MalfunctionAug 19, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE ORTHOKIT ARRIVED AT THE LOCAL WAREHOUSE WITH A DRILL BIT WHERE THE END PIECE IS BROKEN. THIS REPORT INVOLVES ONE (1) DRILL BIT FOR 5.0MM RECON SCREWS/LARGE QC. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15258988 ↗
• InjuryNov 18, 2021Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, THE 3.2MM DRILL BIT BROKE WHILE BEING USED TO PLACE ADOLESCENT LATERAL ENTRY FEMORAL NAIL (ALFN) SYSTEM RECONSTRUCTION SCREWS. THE BROKEN FRAGMENT OF THE DRILL BIT REMAINED INSIDE PATIENT'S BONE AS IT WAS IMPOSSIBLE TO REMOVE. THERE WAS SIXTY (60) MINUTES SURGICAL DELAY. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) DRILL BIT FOR 5.0MM RECON SCREWS/LARGE QC . THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 12839201 ↗
• MalfunctionNov 16, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN ORTHOPEDIC SURGICAL PROCEDURE WHEN SURGEON WAS TRYING TO DRILL THE THREAD CHANNEL TO PASS RECONSTRUCTION SCREWS, THE DRILL BIT BROKE. NO FURTHER INFORMATION PROVIDED. THIS REPORT IS FOR ONE (1) DRILL BIT FOR 5.0MM RECON SCREWS/LARGE QC. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12824445 ↗
• MalfunctionNov 8, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A DRILL BIT WAS FOUND BROKEN AFTER STERILIZATION. AROUND 30MM FROM THE DISTAL TIP OF THE DRILL BIT WAS BROKEN. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) DRILL BIT FOR 5.0MM RECON SCREWS/LARGE QC. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12772524 ↗
• MalfunctionNov 8, 2021Break; Material Integrity Problem; Break; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A DRILL BIT WAS DROPPED AND BROKE DURING A TRAINING SESSION. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) DRILL BIT FOR 5.0MM RECON SCREWS/LARGE QC THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12772293 ↗
• MalfunctionJan 22, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020 THAT THE DRILL BIT BROKE WHEN DRILLING FOR A 5.0 RECON SCREW. THE BROKEN TIP WAS REMOVED AND THE HOLE WAS DRILLED WITH NEW DRILL. THERE WAS A TEN (10) MINUTE SURGICAL DELAY AND ADDITIONAL X-RAYS TO LOCATE THE TIP AND REMOVE IT WERE TAKEN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNK - DRILL (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR ONE (1) DRILL BIT FOR 5.0MM RECON SCREWS/LARGE QC. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11219027 ↗
• MalfunctionOct 11, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED AN UNKNOWN DATE THAT THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION FOUND PRE DRILL BIT HAS SNAPPED OF SIZING DRILL BIT (TIP BROKEN OFF). THE PATIENT OUTCOME IS UNKNOWN. THIS IS REPORT 1 FOR 1 (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9179156 ↗
• MalfunctionAug 1, 2019Break; Break

  DEVICE REPORT FROM THE (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, A DRILL BIT BROKE DURING AN UNKNOWN PROCEDURE. THIS REPORT IS FOR A DRILL BIT FOR 5.0 MM RECON SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8850606 ↗
• InjuryJun 18, 2019Break; Entrapment of Device; Break; Entrapment of Device

  CONCOMITANT DEVICE REPORTED: UNKNOWN NAIL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1).

  Patient problems: Foreign Body In Patient

  MAUDE report 8707593 ↗
• InjuryJun 6, 2019Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT AN UNKNOWN PROCEDURE. DURING THE PROCEDURE, THE DRILL BIT BROKE OFF WHILE IN USE IN THE PATIENT. THE DRILL BIT WAS EMBEDDED AND BURIED IN THE BONE. THE DISTAL TIP WAS RETAINED IN THE PATIENT. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE OUTCOME IS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 8676004 ↗
• InjuryJun 4, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, WHEN DRILLING THE RECON SCREWS IN SYNTHES ADOLESCENT LATERAL ENTRY FEMORAL NAIL, THE DRILL BIT FOR RECON BROKE AND THE BROKEN PIECE HAD TO BE LEFT INSIDE OF THE PATIENT. IF REMOVE, THE BROKEN PIECES WOULD'VE CREATED MORE DAMAGE TRYING TO GET IT OUT. THE SURGEON USED DIFFERENT LOCKING HOLES IN THE NAIL TO COMPLETE THE PROCEDURE, IT WAS SUCCESSFULLY COMPLETED WITH THE DELAY OF 15 MINUTES. PATIENT STATUS WERE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: TRAUMA (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1), UNK - NAILS: FEMORAL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 8667223 ↗
• InjuryMay 31, 2019Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE TIP OF THE DRILL BIT BROKE DURING AN ADOLESCENT FEMORAL NAILING PROCEDURE. UPON REAMING FOR THE INFERIOR HIP SCREW, THE TIP OF THE DRILL BIT BROKE AND WAS LEFT IN SITU EMBEDDED WITHIN THE FEMORAL NECK. THERE WAS AN UNKNOWN HIP SCREW ALREADY IN PLACE ON THE SUPERIOR RECON HOLE OF THE UNKNOWN NAIL. THE SURGEON FELT IT WAS SAFE NOT TO RETRIEVE THE FRAGMENT AND DECIDED TO CONTINUE WITH THE PROCEDURE. THERE WAS NO SURGICAL DELAY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY FURTHER ISSUES. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: HIP SCREW (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). FEMORAL NAIL (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 8659407 ↗
• InjuryMar 25, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN FINLAND AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A FEMUR NAILING PROCEDURE USING AN ADOLESCENT LATERAL FEMORAL NAIL (ALFN). WHEN DRILLING USING AN UNKNOWN GOLDEN DRILL GUIDE, THE DRILL BIT BROKE AND A PIECE OF METAL LEFT IN THE PATIENT'S BODY. IT WAS UNKNOWN IF THERE WAS SURGICAL DELAY. SURGICAL PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. CONCOMITANT MEDICAL PRODUCTS: DRILL GUIDE (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 8449132 ↗
• InjuryJun 7, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, DURING THE PROCEDURE, THE TIP OF THE DRILL BROKE. REPORTEDLY, AT LEAST THE LENGTH OF THE TIP (2 CM) REMAINED IN THE HEAD OF THE LEFT FEMUR. THE SURGEON TRIED TO REMOVE THE PIECE OF DRILL BUT HE WAS UNSUCCESSFUL. PATIENT OUTCOME WAS REPORTED AS GOOD. THIS REPORT IS FOR ONE (1) DRILL BIT FOR 5.0MM RECON SCREWS/LARGE QC. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 7578886 ↗
• MalfunctionFeb 6, 2018Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE FOR HIP SURGERY ON (B)(6) 2018, A DRILL BIT FOR 5.0MM RECON SCREWS/LARGE QC BROKE. THE BROKEN FRAGMENTS OF THE DRILL BIT WERE REMOVED FROM THE PATIENT AND AN ADOLESCENT LATERAL ENTRY FEMORAL NAIL WAS USED TO COMPLETE THE SURGERY. THE PROCEDURE WAS COMPLETED WITH A SURGICAL DELAY OF ALMOST 40 MINUTES AND THE PATIENT WAS STABLE AFTER THE SURGERY. THIS REPORT IS FOR ONE (1) DRILL BIT FOR 5.0MM RECON SCREWS. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7245200 ↗
• InjuryDec 18, 2017Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT DURING AN ORIGINAL SURGERY ON (B)(6) 2017 FOR AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF A FEMUR, THE SURGEON PLANNED TO IMPLANT TWO (2) RECONS SCREWS IN TOTAL. AS THE SURGEON INSERTED THE FIRST RECON SCREW INTO THE PATIENT'S FEMORAL NECK, THE TIP OF THE DRILL BIT BROKE OFF. THE LENGTH OF THE BROKEN FRAGMENT WAS ABOUT 1 - 1.5 INCHES LONG. THE SURGEON DECIDED NOT TO RETRIEVE THE BROKEN FRAGMENT AS IT COULD POTENTIALLY CAUSE MORE DAMAGE. THE SURGEON THEN PROCESSED TO INSERT THE SECOND RECON SCREW USING ANOTHER DRILL BIT THAT WAS AVAILABLE. BOTH THE RECONS SCREWS WERE IMPLANTED IN THE PATIENT AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY DELAY. THE PATIENT IS REPORTED TO BE IN STABLE CONDITION. CONCOMITANT DEVICES REPORTED: RECON SCREW (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) DRILL BIT FOR 5.0MM RECON SCREWS/LARGE QC. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 7126425 ↗
• InjuryMay 8, 2017Break; Material Fragmentation; Break; Material Fragmentation

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT IS REPORTED DURING AN UNKNOWN SURGICAL PROCEDURE ON (B)(6) 2017, AFTER DRILLING FOR THE SECOND RECON SCREW AND REMOVING THE DRILL BIT, IT WAS NOTICED A PORTION OF THE DRILL BIT HAD BEEN LEFT BEHIND. THE INCISION WAS EXTENDED TO FACILITATE THE SURGEON¿S ATTEMPT TO REMOVE THE FRAGMENT. SURGEON DETERMINED IT WOULD BE DETRIMENTAL TO THE PATIENT TO REMOVE THE FRAGMENT. THE BROKEN FRAGMENT OF THE DRILL BIT IS STAINLESS STEEL AND IS NOW EMBEDDED IN PATIENT BONE NEXT TO A TITANIUM SCREW. SURGERY WAS DELAYED APPROXIMATELY 30 MINUTES DUE TO THE ATTEMPT TO REMOVE THE FRAGMENT. CONCOMITANT DEVICES REPORTED: RECON SCREW (QUANTITY 1). THIS REPORT IS FOR ONE (1) DRILL BIT FOR RECON SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6552729 ↗
• MalfunctionMar 29, 2017Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOW: IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2017, THE DRILL BIT BROKE. NO DELAY IN SURGERY WAS REPORTED. NO INFORMATION AVAILABLE ABOUT PATIENT CONDITION AND OUTCOME. THIS REPORT IS FOR ONE (1) DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6442714 ↗
• InjuryMar 9, 2017Break; Break

  IT WAS REPORTED THAT DURING A PROCEDURE FOR A RIGHT FEMUR FRACTURE ON (B)(6) 2017, TWO DRILL BITS BROKE. AS THE SURGEON WAS DRILLING A PATH FOR THE RECON SCREWS WITH A SYNTHES SMALL BATTERY DRIVER, HE APPROACHED THE MEDIAL CALCAR AND AN INCH OF THE DRILL BIT BROKE OFF IN THE FEMORAL NECK REGION. THE SURGEON TRIED AGAIN WITH ANOTHER DRILL BIT AND AN INCH OF THE SECOND DRILL BIT BROKE OFF IN THE FEMORAL NECK REGION. APPROXIMATELY AN INCH OF BOTH DRILL BIT TIPS WERE LEFT IN THE PATIENT. THE SURGEON DID NOT ATTEMPT TO RETRIEVE THE TIPS OF THE DRILL BITS. IT WOULD HAVE CAUSED MORE DAMAGE TO THE PATIENT TO RETRIEVE THE TIPS. THERE WAS A 40 MINUTE SURGICAL DELAY. ROUTINE INTRAOPERATIVE X-RAYS WERE TAKEN. THE SURGEON COULD NOT PLACE THE INFERIOR SCREW AND HAD TO ABANDON THE INTENDED PROCEDURE. THE SURGEON HAD ALREADY PLACED THE ADOLESCENT FEMORAL NAIL AND THE SUPERIOR SCREW (5.0 MM RECON SCREW), BUT WAS UNABLE TO PLACE THE INFERIOR SCREW AFTER THE TIPS OF THE DRILL BIT BROKE. THE SURGEON COMPLETED THE PROCEDURE HAVING PREFERRED TO HAVE IMPLANTED THE SECOND (INFERIOR SCREW). THE PATIENT WAS REPORTED AS STABLE. CONCOMITANT DEVICE REPORTED: SYNTHES SMALL BATTERY DRIVER (QUANTITY OF 1). THIS I

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6391652 ↗