NA 03.010.078Recalls & reported problems

Summary

The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 10886982067487), received between Jan 25, 2017 and Apr 22, 2026 — classified as 23 injuries, 26 malfunctions.

The most frequently reported specific device problem is “Break” (37 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 49 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 22, 2026Break; Entrapment of Device

  IT WAS REPORTED ON (B)(6) 2026, THAT DRILL BIT BROKE OFF IN THE FEMORAL HEAD OF PATIENT AND COULD NOT BE EXTRACTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 24956186 ↗
• MalfunctionApr 8, 2026Break

  ADDITIONAL INFORMATION RECEIVED: 1. HAS THE PATIENT SHOWN ANY SIGNS OF DEVELOPING A SURGICAL SITE INFECTION DUE TO THE EXTENDED SURGICAL DELAY? NO SIGN OF INFECTION. 2. DID THE PATIENT STILL RECEIVE THE SAME SURGICAL OUTCOME? PATIENT RECEIVED SAME OUTCOME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24820416 ↗
• MalfunctionApr 2, 2026Break

  IT WAS REPORTED THAT DURING A FEMORAL RECON NAILING (FRN) SURGERY, THE NAIL GOT DAMAGE AND REAMER WAS BROKEN. THE REAMER WAS PASSING THROUGH GUIDING ZIG, WAS PASSING OUTSIDE OF NAIL BRUSHING THE OUTER SIDE OF NAIL, REQUIRING REMOVAL OF THE NAIL AND REPLACEMENT WITH ANOTHER. THERE WAS NO REPORTED PATIENT HARM, BUT THE PROCEDURE WAS DELAYED BY APPROXIMATELY ONE HOUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24766358 ↗
• MalfunctionFeb 27, 2026Break

  IT WAS REPORTED THAT THE TIP OF THE STEPPED DRILL BIT FOR HIP SCREWS BROKE OFF INTRAOPERATIVELY DURING USE FOR RECON SCREWS. THE EVENT OCCURRED WITH A NEW CONSIGNMENT SET, AND AN ALTERNATIVE DRILL BIT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO IMPACT OR CONSEQUENCE TO THE PATIENT, NO DELAY IN SURGERY, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24472272 ↗
• InjuryFeb 5, 2026Break; Entrapment of Device

  IT WAS REPORTED INTRA-OPERATIVELY, A DRILL BIT BROKE. WHILE TRYING TO RETRIEVE THE BROKEN DRILL BIT, THE HOLLOW REAMER BROKE. ANOTHER DRILL BIT WAS USED TO REDRILL SUCCESSFULLY. A 6.5MM RECON SCREW GOT STUCK AFTER TAPPING MULTIPLE TIMES. WHILE TRYING TO REMOVE THE STUCK SCREW, A SCREWDRIVER WAS DAMAGED. AN EXTRACTION SCREW ALSO STRIPPED DURING THE SURGERY. THE SURGEON WAS NOT ABLE TO IMPLANT THE RECON SCREW SO CHANGED TO THE SURGICAL PLAN TO ACCOMMODATE TRANSVERSE LOCKING ONLY. THE PROCEDURE WAS COMPLETED WITH A ONE-HUNDRED TWENTY (120) MINUTE DELAY.

  Patient problems: Foreign Body In Patient

  MAUDE report 24272580 ↗
• MalfunctionJun 19, 2025Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT THE PATIENT UNDERWENT EMORAL NAILING REVISION OF COMPETITOR IMPLANT DUE TO NON-UNION. ON REAMING THE RECON SCREW THE TIP OF THE REAMER BROKE OFF. THE SURGEON WAS ABLE TO PUNCH THE TIP LATERALLY AND PUT IN A 5.0MM SCREW. REAMER TIP WAS LEFT IN THE PATIENT. THIS ADDED AN ADDITIONAL 30 MINUTES TO THE CASE.

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

  MAUDE report 22293797 ↗
• MalfunctionJun 19, 2025Break; Crack; Break; Crack

  IT WAS REPORTED THAT INSTRUMENTS WERE UNABLE TO BE STERILIZES/ASSEMBLES. CHIPPING AND CRACKING. UNABLE TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22293519 ↗
• MalfunctionJun 17, 2025Break; Break

  IT WAS REPORTED THAT THE TWO PIECES OF THE LFN INSTRUMENTAL BROKE DURING THE SURGICAL PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22234037 ↗
• MalfunctionFeb 6, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON JAN. 27, 2025, THE PATIENT UNDERWENT ORIF SURGERY WITH THE PRODUCTS IN QUESTION. IN THE SURGERY, THE GUIDE PIN WAS INSERTED USING THE PRODUCTS IN QUESTION, BUT IT DID NOT PASS THROUGH THE INTRAMEDULLARY NAIL AND SLIPPED FORWARD AND COULD NOT BE INSERTED IN THE PROPER DIRECTION. THE GUIDE PIN WAS INSERTED BY TILTING THE AIMING ARM BACKWARD, BUT IT SLIPPED FORWARD AGAIN AND COULD NOT BE INSERTED. THE ARM WAS REPOSITIONED, BUT IT WAS LED TOWARD THE GUIDE PIN THAT WAS ALREADY OPEN AND COULD NOT BE INSERTED. SINCE THE GUIDE PIN WAS NOT INSERTED IN THE CORRECT DIRECTION, WE CHANGED THE SCREW POSITION TO THE POSITION OF THE DOWNSTROKE AND TRANSVERSE INSTEAD OF FIXING THE RECONTOURING MODE. THE REASONS FOR THE FAILURE WERE THAT THE INTRAMEDULLARY NAIL WAS PLACED IN A PATIENT WITH A TIGHT MEDULLARY CAVITY, THE GUIDE PIN WAS GUIDED IN THE DIRECTION OF THE GUIDE PIN THAT WAS PLACED FIRST, THE POSITION OF THE AIMING ARM WAS NOT CHANGED MUCH BECAUSE THE INTRAMEDULLARY NAIL WAS PLACED TIGHTLY, AND THE SLEEVE MAY HAVE BEEN SLIGHTLY DEFLECTED.

  Patient problems: Insufficient Information

  MAUDE report 21322841 ↗
• MalfunctionJun 18, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN ORIF SURGERY. THE GUIDE ROD AND THE DRILL BIT INTERFERED AND THE TIP OF THE DRILL BIT BROKE OFF WHEN DRILLING WITHOUT REMOVING THE GUIDE ROD AFTER INSERTING THE NAIL OVER IT. THE SURGEON REMOVED THE NAIL ONCE BECAUSE THE BROKEN DRILL BIT WAS LEFT IN THE BODY, REMOVED THE BROKEN DRILL BIT, AND REINSERTED IMPLANTS INCLUDING THE NAIL. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) 4.5MM/6.5MM STEPPED DRILL BIT LARGE QC/485MM THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19564022 ↗
• MalfunctionFeb 9, 2024Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2024, THAT THE STEPPED REAMER BROKE DURING SURGERY. THE BROKEN TIP OF THE STEPPED REAMER WAS RETAINED IN THE PATIENT AS THE SURGEON FELT IT WOULD BE MORE DAMAGING TO ATTEMPT TO REMOVE THE FRAGMENT. THE IM NAIL WAS REPOSITIONED TO AVOID FRAGMENTS, AND SURGERY WAS COMPLETED. THE SURGERY WAS DELAYED FOR 10 MINUTES. A BROKEN FRAGMENT WAS LEFT IN-SITUE, NAIL WAS REPOSITIONED, AND THE SURGEON. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. FRAGMENT WAS RETAINED IN BONE AS ATTEMPTING TO REMOVE IT WOULD HAVE CAUSED FURTHER DAMAGE. THIS REPORT IS FOR ONE (1) 4.5/6.5 STEPPED DRILL BIT LARGE QC/485 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18682418 ↗
• MalfunctionJan 22, 2024Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT ON JANUARY 4, 2023, THERE WAS AN ISSUE WITH A COUPLE DIFFERENT INSTRUMENTS IN THE FRN (FEMORAL RECON NAIL) SET. WHILE INSERTING THE NAIL, OUR SURGEON STRUCK THE DRIVING CAP AND THE THREADED PORTION BROKE OFF AND BECAME LODGED IN THE INSERTION HANDLE. LUCKILY, THE NAIL WAS ALREADY INSERTED ALL THE WAY SO WE WERE ABLE TO PROCEED WITH THE CASE. IN THE SAME CASE, OUR SURGEON BEGAN DRILLING WITH THE STEPPED DRILL AND NOTICED SOME INTERFERENCE BETWEEN THE DRILL AND THE NAIL. HE CONTINUED TO DRILL AND THEN THE TIP OF THE DRILL BROKE OFF INTO THE PATIENTS FEMORAL NECK. HE WAS ABLE TO RETRIEVE THE BROKEN PIECE AND PROCEED WITH THE CASE, BUT IT CERTAINLY CAUSED A DELAY. THIS REPORT IS FOR ONE (1) 4.5/6.5 STEPPED DRILL BIT LARGE QC/485 THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18553601 ↗
• MalfunctionJun 6, 2023Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2023, THAT WHILE DRILLING FOR THE RECON SCREW, THE TIP OF THE DRILL BIT BROKE OFF ON THE MEDIAL (FAR) SIDE OF THE NAIL. THE DECISION TO BACK THE NAIL UP AND RE-DRILL WAS MADE. WHILE BACK SLAPPING THE NAIL THE DRIVING CAP BROKE AT THE THREAD SHAFT JUNCTION. THERE WAS A SURGICAL DELAY FOR 10-15 MINS. THE SURGERY WAS COMPLETED SUCCESSFULLY. CONCOMITANT PRODUCT DETAILS: UNK - NAILS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY - UNKNOWN), UNK - SCREWS: TRAUMA (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY - UNKNOWN) THIS REPORT IS FOR ONE (1) 4.5/6.5 STEPPED DRILL BIT LARGE QC/485 THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17071655 ↗
• InjuryNov 11, 2022Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2022 DURING INSERTION OF A FEMORAL RECON NAIL TO FIX A PROXIMAL FEMUR FRACTURE, THE DRILL BITS IN QUESTION BROKE. A 3.2MM GUIDE WIRE WAS PLACED IN THE PIRIFORMIS FOSSA AND A 14MM ENTRY REAMER WAS USED TO GAIN ENTRANCE TO THE FEMORAL CANAL. A 2.5MM BALL TIP GUIDE WIRE WAS PLACED AND THE LENGTH OF THE NAIL WAS MEASURED. SYNTHES FLEXIBLE REAMERS WERE USED TO THE DIAMETER OF 12.5MM. A 11X420 NAIL WAS CHOSEN. NAIL WAS ATTACHED TO THE AIMING ARM WITH THE CONNECTION SCREW AND CHECKED VISUALLY FOR ALIGNMENT BY SURGEON AND SCRUB AT THE BACK TABLE. NAIL WAS INSERTED TO THE PROPER DEPTH AND A RECON TROCAR SLEEVE WAS INSERTED IN THE INFERIOR RECON HOLE OF AIMING ARM. RECON TROCAR SLEEVE WAS FINDING RESISTANCE DUE TO SOFT TISSUE AND INCISION. A MALLET WAS USED AND SURGEON HAMMERED THE TROCAR SLEEVE TO THE LATERAL CORTEX OF THE FEMUR. A 3.2 MM GUIDE WIRE WAS PLACED AND CHECKED BY X-RAY. THIS GUIDE WIRE WAS TO ANTERIOR AND SURGEON DECIDED TO BACKSLAP THE NAIL AND REINSERT THE NAIL TO ALIGN RECON HOLES WITHIN THE FEMORAL NECK. INFERIOR TROCAR SLEEVE WAS ONCE AGAIN HAMMERED INTO PLACE AND A 3.2MM GUIDE WIRE WAS PLACED AND CHECKED BY X-RAY. SURGEON LIKED THE LOCATION O

  Patient problems: Foreign Body In Patient

  MAUDE report 15780899 ↗
• InjuryNov 11, 2022Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2022 DURING INSERTION OF A FEMORAL RECON NAIL TO FIX A PROXIMAL FEMUR FRACTURE, THE DRILL BITS IN QUESTION BROKE. A 3.2MM GUIDE WIRE WAS PLACED IN THE PIRIFORMIS FOSSA AND A 14MM ENTRY REAMER WAS USED TO GAIN ENTRANCE TO THE FEMORAL CANAL. A 2.5MM BALL TIP GUIDE WIRE WAS PLACED AND THE LENGTH OF THE NAIL WAS MEASURED. SYNTHES FLEXIBLE REAMERS WERE USED TO THE DIAMETER OF 12.5MM. A 11X420 NAIL WAS CHOSEN. NAIL WAS ATTACHED TO THE AIMING ARM WITH THE CONNECTION SCREW AND CHECKED VISUALLY FOR ALIGNMENT BY SURGEON AND SCRUB AT THE BACK TABLE. NAIL WAS INSERTED TO THE PROPER DEPTH AND A RECON TROCAR SLEEVE WAS INSERTED IN THE INFERIOR RECON HOLE OF AIMING ARM. RECON TROCAR SLEEVE WAS FINDING RESISTANCE DUE TO SOFT TISSUE AND INCISION. A MALLET WAS USED AND SURGEON HAMMERED THE TROCAR SLEEVE TO THE LATERAL CORTEX OF THE FEMUR. A 3.2 MM GUIDE WIRE WAS PLACED AND CHECKED BY X-RAY. THIS GUIDE WIRE WAS TO ANTERIOR AND SURGEON DECIDED TO BACKSLAP THE NAIL AND REINSERT THE NAIL TO ALIGN RECON HOLES WITHIN THE FEMORAL NECK. INFERIOR TROCAR SLEEVE WAS ONCE AGAIN HAMMERED INTO PLACE AND A 3.2MM GUIDE WIRE WAS PLACED AND CHECKED BY X-RAY. SURGEON LIKED THE LOCATION O

  Patient problems: Foreign Body In Patient

  MAUDE report 15780862 ↗
• InjuryJun 28, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE A 14MM CANNULATED DRILL BIT BROKE AT THE BASE WHILE TRYING TO MEDIALIZE WITH OPENING DRILL, NO FRAGMENTS WERE GENERATED AND NOTHING WAS LEFT INSIDE THE PATIENT. THEN AFTER INSERTING THE NAIL, THE 4.5/6.5 STEPPED DRILL BIT LARGE QC/485 BROKE OFF AT THE TIP AFTER COMING INTO CONTACT WITH A LARGE POINT TO POINT CLAMP (WEBER CLAMP). THE BROKEN PIECE WAS LEFT INSIDE THE BONE AS IT WAS DEEMED TOO DIFFICULT TO REMOVE. SURGERY COMPLETED SUCCESSFULLY. NO OTHER PATIENT INFO AT THIS TIME. THIS REPORT IS FOR (1) 4.5/6.5 STEPPED DRILL BIT LARGE QC/485. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 14842017 ↗
• InjuryJun 23, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED ON (B)(6) 2022, THAT WHILE DRILLING FOR A 6.5 RECON SCREW, THE STEPPED DRILL BIT BROKE OFF LEAVING A PIECE OF THE DRILL INSIDE THE PATIENT. IT WAS SUBSEQUENTLY REMOVED AND CONFIRMED ON X-RAY. THERE WAS A SURGICAL DELAY OF 15 MINUTES. PROCEDURE WAS SUCCESSFULLY COMPLETED. CONCOMITANT DEVICE REPORTED: UNK - SCREWS: RECON (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS REPORT IS FOR (1) 4.5/6.5 STEPPED DRILL BIT LARGE QC/485. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 14789530 ↗
• MalfunctionMay 16, 2022Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE TIP OF DRILL BIT IS DULL. THIS COMPLAINT INVOLVES ONE DEVICE REAMER Ø4.5/6.5 L484 F/HIP SCREWS LFN. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14409974 ↗
• MalfunctionMay 3, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN UNKNOWN SURGERY FOR THE LFN INSERTION ON (B)(6) 2022, IT WAS OBSERVED THAT THE REAMER DEVICE WAS COMING INTO CONTACT WITH THE NAIL WHEN PASSED THROUGH THE GUIDE SLEEVES INSERTED THROUGH THE AIMING ARM, AND WAS CAUSING IT TO ¿STICK¿ BEFORE PASSING THROUGH THE NAIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) REAMER Ø4.5/6.5 L484 F/HIP SCREWS LFN DEVICE. THIS COMPLAINT INVOLVES TWO (2) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14269877 ↗
• InjuryJan 20, 2022Break; Entrapment of Device; Break; Entrapment of Device

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE DRILL BITS WERE DAMAGED DURING THE PROCEDURE. TWO OF THE BROKEN DRILL BITS FRAGMENTS REMAIN IN THE PATIENT¿S BONE. TWO OF THE HIP SCREWS WERE IMPLANTED OUTSIDE OF THE NAIL LFN. THE SCREWS WERE EXTRACTED AND THERE WAS A FORTY (40) MINUTES SURGICAL DELAY. THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS REPORT INVOLVES ONE (1) 4.5MM/6.5MM STEPPED DRILL BIT LARGE QC/485MM. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 13308477 ↗
• MalfunctionDec 13, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE, IT WAS NOTED THAT THE DRILL STOP FAILED ON THE DRILL BIT FOR RECON SCREWS AND THE DRILL BIT ADVANCED INTO AND PAST THE PELVIS. THE BLADDER DID NOT APPEAR TO BE PERFORATED AT THE TIME OF SURGERY, BUT ADDITIONAL TESTS (CT SCAN) WERE ORDERED TO CONFIRM. A SECOND DRILL BIT WAS PROVIDED, AND THE DRILL STOP FAILED AGAIN. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. NO PATIENT CONSEQUENCES WERE NOTED. THIS REPORT IS FOR A 4.5MM/6.5MM STEPPED DRILL BIT. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12983176 ↗
• MalfunctionDec 13, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE ON AN UNKNOWN DATE, IT WAS NOTED THAT THE DRILL STOP FAILED ON THE DRILL BIT FOR RECON SCREWS AND THE DRILL BIT ADVANCED INTO AND PAST THE PELVIS. THE BLADDER DID NOT APPEAR TO BE PERFORATED AT THE TIME OF SURGERY, BUT ADDITIONAL TESTS (CT SCAN) WERE ORDERED TO CONFIRM. A SECOND DRILL BIT WAS PROVIDED, AND THE DRILL STOP FAILED AGAIN. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. NO PATIENT CONSEQUENCES WERE NOTED. THIS REPORT IS FOR A 4.5MM/6.5MM STEPPED DRILL BIT. THIS IS REPORT 1 OF 2 FOR PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12983143 ↗
• InjuryNov 1, 2021Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING THE INSERTION OF A FEMORAL NAIL, A DRILL BIT BROKE OFF IN THE PATIENT'S FEMORAL NECK AND WAS UNABLE TO BE REMOVED. A 20MM DRILL BIT SEGMENT WAS LEFT IN THE FEMORAL HEAD. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH TWENTY MINUTES SURGICAL DELAY. PATIENT STATUS IS UNKNOWN. CONCOMITANT DEVICE: UNKNOWN FEMORAL NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1). THIS REPORT IS FOR (1) 4.5MM/6.5MM STEPPED DRILL BIT LARGE QC/485MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient

  MAUDE report 12727927 ↗
• MalfunctionJun 9, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING THE PROCEDURE THE TIP OF THE DRILL/REAMER BROKE OFF. THE BROKEN TIP WAS REMOVED FROM THE FEMORAL HEAD. THIS REPORT INVOLVES ONE (1) 4.5MM/6.5MM STEPPED DRILL BIT LARGE QC/485MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11967053 ↗
• MalfunctionMar 29, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE STEPPED DRILL BIT AND DRILL STOP WERE SLIPPING. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT CONSEQUENCE. THERE IS NO FURTHER INFORMATION AVAILABLE. CONCOMITANT DEVICES REPORTED: UNKNOWN HIP SCREWS (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN), UNKNOWN LFN NAIL (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1) THIS REPORT IS FOR ONE (1) 4.5MM/6.5MM STEPPED DRILL BIT LARGE QC/485MM. THIS IS REPORT 1 OF 2 FOR PC (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11586284 ↗