NA 03.010.069Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10886982067418), received between Nov 16, 2020 and Jun 9, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (10 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 9, 2026No Apparent Adverse Event

  IT WAS REPORTED ON AN UNKNOWN DATE THAT THE FOLLOWING ITEMS ARRIVED DAMAGED (BENT) AS A PART OF A NEW MULTILOC SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25444502 ↗
• MalfunctionFeb 20, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT UNDERWENT ORIF SURGERY FOR PROXIMAL HUMERUS FRACTURES. DURING THE PROCEDURE, ONE DISTAL HOLE WAS DRILLED AND CONFIRMED BY IMAGING TO HAVE PASSED THROUGH THE NAIL HOLE. WHILE DRILLING ANOTHER HOLE, THE DRILL BIT INTERFERED WITH THE NAIL. ALTHOUGH RECOVERY METHODS SUCH AS LIGHTLY TAPPING WITH A PLASTIC HAMMER, CREATING A PILOT HOLE WITH A K-WIRE, AND MANUALLY FINE-TUNING THE SLEEVE WERE ATTEMPTED, THE DRILL BIT WOULD NOT PASS THROUGH THE NAIL. AS A RESULT, NO SCREW WAS INSERTED INTO THAT HOLE AND FIXATION WAS PERFORMED WITH ONE DISTAL LOCKING SCREW. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHIN A THIRTY (30) MINUTE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24400964 ↗
• MalfunctionAug 6, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TROCAR WAS BENT AND WILL NOT GO INTO THE SLEEVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22725757 ↗
• MalfunctionApr 25, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE THE TROCAR WAS BENT.

  Patient problems: Insufficient Information

  MAUDE report 21909030 ↗
• MalfunctionJul 11, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT ORIF SURGERY WITH THE PRODUCTS IN QUESTION. THIS IS A REPORT OF INTRAOPERATIVE INTERFERENCE BETWEEN THE DRILL TIP AND THE INTRAMEDULLARY NAIL. DURING THE SURGERY, AFTER INSERTION OF AN INTRAMEDULLARY NAIL AND PROXIMAL FIXATION, DISTAL ANTEROLATERAL SCREW FIXATION WAS PERFORMED. DURING DISTAL POSTEROLATERAL SCREW FIXATION, THE DRILL TIP INTERFERED WITH THE INTRAMEDULLARY NAIL. AFTER INTERFERENCE, BECAUSE OF THE POSSIBILITY OF FORCE ON THE SLEEVE DUE TO SOFT TISSUE TENSION, A SMALL AMOUNT OF SKIN INCISION AND DEPLOYMENT WAS ADDED. ATTEMPTED TO DRILL AGAIN BUT AGAIN THERE WAS INTERFERENCE. THE SURGEON PULLED OUT THE DRILL AND TRIED TO DRILL A HOLE WITH A SMALLER 3.0 MM DIAMETER K-WIRE, BUT THE INTERFERENCE HAPPENED AGAIN. THE CONNECTION BETWEEN THE INTRAMEDULLARY NAIL AND THE HANDLE AND THE CONNECTION BETWEEN THE AIMING ARM AND THE INSERTION HANDLE WERE CHECKED AGAIN FOR LOOSENESS. THERE WAS NO INTERFERENCE DURING THE DRY CHECK BEFORE INSERTION. WHEN CHECKED FROM THE SIDE WITH THE SLEEVE IN PLACE, IT WAS CLEARLY OBSERVED THAT THE SLEEVE WAS DISPLACED BACKWARD. THE SURGEON CONSIDERED REMOVING THE AIMING ARM AND PERFORMING THE I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19725954 ↗
• MalfunctionJul 11, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT ORIF SURGERY WITH THE PRODUCTS IN QUESTION. THIS IS A REPORT OF INTRAOPERATIVE INTERFERENCE BETWEEN THE DRILL TIP AND THE INTRAMEDULLARY NAIL. DURING THE SURGERY, AFTER INSERTION OF AN INTRAMEDULLARY NAIL AND PROXIMAL FIXATION, DISTAL ANTEROLATERAL SCREW FIXATION WAS PERFORMED. DURING DISTAL POSTEROLATERAL SCREW FIXATION, THE DRILL TIP INTERFERED WITH THE INTRAMEDULLARY NAIL. AFTER INTERFERENCE, BECAUSE OF THE POSSIBILITY OF FORCE ON THE SLEEVE DUE TO SOFT TISSUE TENSION, A SMALL AMOUNT OF SKIN INCISION AND DEPLOYMENT WAS ADDED. ATTEMPTED TO DRILL AGAIN BUT AGAIN THERE WAS INTERFERENCE. THE SURGEON PULLED OUT THE DRILL AND TRIED TO DRILL A HOLE WITH A SMALLER 3.0 MM DIAMETER K-WIRE, BUT THE INTERFERENCE HAPPENED AGAIN. THE CONNECTION BETWEEN THE INTRAMEDULLARY NAIL AND THE HANDLE AND THE CONNECTION BETWEEN THE AIMING ARM AND THE INSERTION HANDLE WERE CHECKED AGAIN FOR LOOSENESS. THERE WAS NO INTERFERENCE DURING THE DRY CHECK BEFORE INSERTION. WHEN CHECKED FROM THE SIDE WITH THE SLEEVE IN PLACE, IT WAS CLEARLY OBSERVED THAT THE SLEEVE WAS DISPLACED BACKWARD. THE SURGEON CONSIDERED REMOVING THE AIMING ARM AND PERFORMING THE I

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19725784 ↗
• MalfunctionOct 3, 2023Crack; Material Deformation; Crack; Material Deformation

  IT WAS REPORTED ON UNKNOWN EVENT DATE THAT THE SURGEON DAMAGED TROCAR OF THE HINDFOOT ARTHRODESIS NAIL SET FROM LOANERS. THE DR. TOOK THE TROCAR TIP AND USED IT AS A PIN WRENCH CAUSING THE TIP OF THE TROCAR TO BEND AND GET A CRACK LINE IN THE METAL. THERE WAS NO SURGICAL DELAY. THE PROCEDURE COMPLETES SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 3.2MM TROCAR. THIS IS REPORT 1 OF 1 FOR COMPLAINT(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17863801 ↗
• MalfunctionJun 10, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED ON (B)(6) 2022, THE 12MM PROTECTION SLEEVE, DRILL SLEEVE AND TROCAR GOT STUCK IN THE TARGETING ARM OF THE ADOLESCENT LATERAL ENTRY FEMORAL NAIL. SURGERY WAS COMPLETED WITH A SURGICAL DELAY OF 30 MINUTES. THERE WAS A PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 8.0MM/3.2MM DRILL SLEEVE 200MM THIS IS REPORT 5 OF 5 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14653952 ↗
• MalfunctionSep 28, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING AN ORTHOPEDIC PROCEDURE, THE PROXIMAL LOCKING SCREW MISSED THE PROXIMAL LOCKING HOLE. TROCARS FOR PROXIMAL LOCKING SCREWS ARE STUCK TOGETHER AND THE SURGEON CHOSE TO USE ANOTHER OPTION. PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY SURGICAL DELAY. NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE (1) 3.2MM TROCAR. THIS IS REPORT 1 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12542451 ↗
• MalfunctionJun 15, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT FOR A SURGERY. DURING THE SURGERY, WHEN THE SURGEON WAS INSTALLING A TIBIA NAIL USING OUR SUPRAPATELLAR TIBIA NAILING SYSTEM, UNABLE TO GET THE PROXIMAL LOCKING SCREWS THROUGH THE NAIL USING THE AIMING ARM AND THE DEVICES MAY BE OUT OF ALIGNMENT. IT IS UNKNOWN IF FRAGMENTS GENERATED. THERE WAS NO SURGICAL DELAY. THE PROCEDURE SUCCESSFULLY COMPLETED. NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNK - SCREW (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). UNK - NAILS (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: UNKNOWN). THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS REPORT IS FOR (1) 3.2MM TROCAR. THIS REPORT IS 3 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12004727 ↗
• MalfunctionMay 27, 2021Device-Device Incompatibility; Device-Device Incompatibility

  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 (ORIF) SURGERY FOR THE PROXIMAL HUMERAL FRACTURE WITH THE INSTRUMENTS AND NAIL IN QUESTION. THE SURGEON CHECKED THE NAIL SIZE TO BE USED BEFORE SURGERY. THE SURGEON WAS PLANNING TO USE A 9.5 MM NAIL, BUT IN THE PREOPERATIVE IMAGE, THE MEDULLARY CAVITY WAS UNEXPECTEDLY SMALL, SO HE USED AN 8.0 MM NAIL. THE INTRAMEDULLARY NAIL WAS INSERTED THROUGH THE GUIDE ROD, BUT THE MEDULLARY CAVITY WAS TOO NARROW TO GET INSIDE. THE SURGEON USED A HAMMER BECAUSE THE NAIL COULD NOT BE INSERTED (SALES ADVISED AGAINST IT. THE HOSPITAL DID NOT HAVE A REAMER). THE NAIL COULD BE INSERTED UP TO THE SPECIFIED POSITION. THE SURGEON INSERTED THREE PROXIMAL SCREWS AND MOVED ON TO INSERT THE DISTAL SCREWS, BUT THE DRILL BIT INTERFERED WITH THE NAIL, AND IT DID NOT GO IN, SO THE SURGEON REMOVED THE DRILL BIT, TAP IT WITH A HAMMER, LET IT GO THROUGH THE INTRAMEDULLARY NAIL, RE-ATTACH IT TO THE DRILL BIT, AND DRILL TO THE OPPOSITE SIDE. AFTER MEASURING, A SCREW WAS INSERTED. BECAUSE THE DRILL BIT INTERFERED ON THE PROXIMAL SIDE AS WELL, THE SAME PROCED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11895116 ↗
• MalfunctionMay 27, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON APRIL 30, 2021, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY FOR THE PROXIMAL HUMERAL FRACTURE WITH THE INSTRUMENTS AND NAIL IN QUESTION. THE SURGEON CHECKED THE NAIL SIZE TO BE USED BEFORE SURGERY. THE SURGEON WAS PLANNING TO USE A 9.5 MM NAIL, BUT IN THE PREOPERATIVE IMAGE, THE MEDULLARY CAVITY WAS UNEXPECTEDLY SMALL, SO HE USED AN 8.0 MM NAIL. THE INTRAMEDULLARY NAIL WAS INSERTED THROUGH THE GUIDE ROD, BUT THE MEDULLARY CAVITY WAS TOO NARROW TO GET INSIDE. THE SURGEON USED A HAMMER BECAUSE THE NAIL COULD NOT BE INSERTED (SALES ADVISED AGAINST IT. THE HOSPITAL DID NOT HAVE A REAMER). THE NAIL COULD BE INSERTED UP TO THE SPECIFIED POSITION. THE SURGEON INSERTED THREE PROXIMAL SCREWS AND MOVED ON TO INSERT THE DISTAL SCREWS, BUT THE DRILL BIT INTERFERED WITH THE NAIL, AND IT DID NOT GO IN, SO THE SURGEON REMOVED THE DRILL BIT, TAP IT WITH A HAMMER, LET IT GO THROUGH THE INTRAMEDULLARY NAIL, RE-ATTACH IT TO THE DRILL BIT, AND DRILL TO THE OPPOSITE SIDE. AFTER MEASURING, A SCREW WAS INSERTED. BECAUSE THE DRILL BIT INTERFERED ON THE PROXIMAL SIDE AS WELL, THE SAME PRO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11895113 ↗
• MalfunctionMay 27, 2021Device-Device Incompatibility; Device-Device Incompatibility

  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 (ORIF) SURGERY FOR THE PROXIMAL HUMERAL FRACTURE WITH THE INSTRUMENTS AND NAIL IN QUESTION. THE SURGEON CHECKED THE NAIL SIZE TO BE USED BEFORE SURGERY. THE SURGEON WAS PLANNING TO USE A 9.5 MM NAIL, BUT IN THE PREOPERATIVE IMAGE, THE MEDULLARY CAVITY WAS UNEXPECTEDLY SMALL, SO HE USED AN 8.0 MM NAIL. THE INTRAMEDULLARY NAIL WAS INSERTED THROUGH THE GUIDE ROD, BUT THE MEDULLARY CAVITY WAS TOO NARROW TO GET INSIDE. THE SURGEON USED A HAMMER BECAUSE THE NAIL COULD NOT BE INSERTED (SALES ADVISED AGAINST IT. THE HOSPITAL DID NOT HAVE A REAMER). THE NAIL COULD BE INSERTED UP TO THE SPECIFIED POSITION. THE SURGEON INSERTED THREE PROXIMAL SCREWS AND MOVED ON TO INSERT THE DISTAL SCREWS, BUT THE DRILL BIT INTERFERED WITH THE NAIL, AND IT DID NOT GO IN, SO THE SURGEON REMOVED THE DRILL BIT, TAP IT WITH A HAMMER, LET IT GO THROUGH THE INTRAMEDULLARY NAIL, RE-ATTACH IT TO THE DRILL BIT, AND DRILL TO THE OPPOSITE SIDE. AFTER MEASURING, A SCREW WAS INSERTED. BECAUSE THE DRILL BIT INTERFERED ON THE PROXIMAL SIDE AS WELL, THE SAME PROCE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11895018 ↗
• MalfunctionNov 16, 2020Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF A LOANER SET AT FSL UPS (B)(6) SITE, IT WAS OBSERVED THAT A TROCAR WAS BENT. THERE WAS NO PATIENT OR HOSPITAL INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR (1) 3.2MM TROCAR. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10845147 ↗