NA 03.025.040Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10886982069900), received between Feb 20, 2018 and Jun 24, 2025 — classified as 2 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (14 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 24, 2025Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  TFNA AIMING ARM AND ALL ASSOCIATED PIECES NEED TO BE REPLACED DUE TO DIFFICULTY AND ABNORMALLY HIGH RESISTANCE EXPERIENCED WHEN INSERTING GUIDE SLEEVES. THEY APPEARED TO GET JAMMED AND STUCK BEFORE FULL INSERTION WAS ACHIEVED. THIS WAS DISCOVERED DURING REPROCESSING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22320939 ↗
• MalfunctionNov 25, 2024Device-Device Incompatibility; Device-Device Incompatibility

  ON ONE KIT TFNA, IT WAS NOTICED, THE FOLLOWING ISSUES: THE RED AND YELLOW MARKINGS ON THE GUIDE SLEEVE, AS WELL AS THOSE OF THE IMPACTOR ARE ERASED. THE TWO CONNECTION SCREWS DO NOT FIT WITH THE HEXAGON SCREWDRIVER 8MM. THESE REFERENCES ARE SUPPOSED TO ALLOW GRIPPING. THE PROTECT SLEEVE DOES NOT FIT PROPERLY INTO THE CARBON AIM ARMS AND SLIPPING. WHICH IS ANNOYING, DURING THE INTERVENTION. CARBON AIM ARMS ARE INCOMPLETE: THE "RING" VISIBLE IS MISSING. THE LISTING OF THIS INSTRUMENT IS, IN FACT, UNCLEAR. THESE REFERENCES SHOULD INCLUDE THREE ELEMENTS (CARBON VISOR, SCREW AND RING), EACH WITH ITS OWN REFERENCE. ISSUE NOTICED, BY THE SALES REP, DURING A TRAINING WITH THE USERS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20775677 ↗
• MalfunctionNov 28, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE WARP INSERTION HANDLE, AIMING ARM, AND OUTER DRILL SLEEVE CROSS-THREADED ATTACHMENT PLATE TO PROX FEMUR PLATE. -RUSTED REMOVAL DEVICE. THE PRODUCT WAS SAID TO CONTAIN ¿RUST¿ FROM THE FACILITY. IT WAS DEEMED "UNUSABLE" AS A CONTAMINATION RISK. THERE WAS NO REVISION SURGERY OR HARDWARE REMOVAL. THE PATIENT WAS NOT AFFECTED, NOR WERE THEY CHARGED. THESE ARE NOT ITEMS OWNED BY THE HOSPITAL, NOR WERE THEY CHARGED. THIS REPORT IS FOR ONE (1) 11.0/8.0 PROTECTION SLEEVE 188 FOR ASLS THIS IS REPORT 4 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18222230 ↗
• MalfunctionNov 2, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING SURGERY ON (B)(6) 2023, A 4.2 DRILL FOR THE DISTAL INTERLOCK SCREW IN A SHORT TFNA MISSED THE SCREW HOLE AND WENT POSTERIOR TO THE NAIL. THE CORRECT SLEEVES AND DRILL WERE USED. THE INSERTION HANDLE WAS REMOVED BECAUSE THE SURGEON NEEDED A CLEAR X-RAY TO GUIDE THE DRILL THROUGH THE NAIL-FREE HAND SURGERY. THERE IS NO "NAIL HEAD". TFNA (TROCHANTERIC FEMORAL NAIL ADVANCED). PATIENT CONSEQUENCES IN RELATION TO THE REPORTED EVENT WERE ADDED TIME AND MORE X-RAYS. THIS REPORT IS FOR ONE (1) PROTECT SLEEVE 11/8 L188 THIS IS REPORT 6 OF 6 FOR (B)(4) .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18057230 ↗
• MalfunctionSep 21, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ITEM WAS DAMAGED BEYOND REPAIR IN THE STERILE PROCESSING DEPARTMENT. THE ITEM WAS BENT, SO THEREFORE IT WAS THROWN AWAY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE11.0MM/8.0MM PROTECTION SLEEVE 188MM FOR ASLS . THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17790477 ↗
• MalfunctionSep 18, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED THAT (B)(6) 2023, THAT THE PROTECTIONISTIC SHEATH, PASSES FORCED THROUGH THE DIRECTIONAL ARM. THIS REPORT IS FOR ONE (1)PROTECT SLEEVE 11/8 L188. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17765557 ↗
• MalfunctionJul 11, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON (B)(6) 2023, THAT THE OUTER TROCAR WAS WARPED AND GRABS THE INNER TROCAR TOO HARD. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT CONSEQUENCES/OUTCOME. THIS REPORT IS FOR ONE (1) 11.0/8.0 PROTECTION SLEEVE 188 FOR ASLS THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17300822 ↗
• MalfunctionMar 13, 2023Material Deformation; Material Deformation

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DRILL SLEEVE WAS BENT BEYOND BEING ABLE TO USE. THE TORQUE LIMITING ATTACHMENT WAS AGAIN BENT AND NOT ABLE TO CONNECT TO SHAFT. THE AIMING ARM WAS CRACKED IN CARBON FIBER AND THE T HANDLE WOULD NOT CONNECT PROPERLY TO QUICK CONNECT ATTACHMENT FOR THE HANDLE. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 11.0MM/8.0MM PROTECTION SLEEVE 188MM FOR ASLS. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16530149 ↗
• MalfunctionJan 5, 2022Device-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 OPEN REDUCTION INTERNAL FIXATION SURGERY FOR TROCHANTERIC FRACTURE OF FEMUR. WHILE DRILLING THE HOLE FOR A LOCKING SCREW, THE DRILL BIT INTERFERED POSTERIOR PART ON THE HOLE OF A NAIL. THE SURGEON REMOVED THE DRILL SLEEVE AND HIT THE DRILL BIT WITH A HAMMER. BECAUSE THE DRILL BIT WAS CONTINUED TO BE HAMMERED IN THE STATE OF INTERFERING WITH THE NAIL HOLE, THE DRILL BIT GOT WORN OUT AND COULD NOT BE USED. THE SURGERY WAS COMPLETED WITHIN (30) MINUTES DELAY. IT IS CONSIDERED THAT THERE MAY BE PROBLEMS SUCH AS DISTORTION IN INSTRUMENTS SUCH AS SLEEVE, INSERTION HANDLE, AND CONNECTING SCREW. PATIENT OUTCOME IS REPORTED AS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR (1) UNKNOWN SLEEVE. THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13171064 ↗
• MalfunctionJul 22, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON UNKNOWN DATE, PATIENT WILL UNDERGO A TFNA PROCEDURE. DURING STERILE PROCESSING, WHILE CHECKING PROTECTION SLEEVE FOR SHORT TFNA BEFORE INSERTING TFNA NAIL AND IT WAS MISALIGNED. NO PATIENT CONSEQUENCES NOTED. THE PROCEDURE OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES (4) DEVICES. THIS REPORT IS FOR (1) 1.0/8.0 PROTECTION SLEEVE 188 FOR ASLS. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12215084 ↗
• InjuryJun 18, 2020Use of Device Problem; Device-Device Incompatibility; Use of Device Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A FEMUR FRACTURE PROCEDURE USING RETROGRADE FEMORAL NAIL. DURING THE PROCEDURE, AN INCORRECT PROTECTION SLEEVE WAS USED AND THE SCREWS MISSED THE NAIL LEAVING A SMALL HOLE IN THE NAIL. THE SCREWS WERE REMOVED. THE SURGEON INSERTED THE CORRECT PROTECTION SLEEVE, DRILLED AND INSERTED SCREWS. THERE WAS A FIVE (5) MINUTE SURGICAL DELAY. THE PROCEDURE OUTCOME IS UNKNOWN. THERE WAS NO PATIENT HARM. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. THIS REPORT IS FOR ONE (1) 11.0MM/8.0MM PROTECTION SLEEVE 188MM FOR ASLS. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Injury

  MAUDE report 10171981 ↗
• MalfunctionMay 5, 2020Device-Device Incompatibility; Device-Device Incompatibility

  CONCOMITANT DEVICES REPORTED: UNKNOWN LOCKING SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1), PEDICLE ACCESS CANNULA SHAFT (PART# 03.632.322, LOT# 7011915, QUANTITY 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10025980 ↗
• MalfunctionApr 27, 2020Device-Device Incompatibility; Device-Device Incompatibility

  CONCOMITANT DEVICE REPORTED: AIMING ARM LOCKING DEVICE (PART NUMBER: 03.037.015, LOT NUMBER: 9501063, QUANTITY: 1).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10003504 ↗
• MalfunctionApr 24, 2020Device-Device Incompatibility; Device-Device Incompatibility

  THIS REPORT IS FOR AN UNKNOWN PROTECTION SLEEVE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9996127 ↗
• MalfunctionMar 31, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT A SURGERY. DURING THE SURGERY, THE DRILL BIT INTERFERED WITH THE NAIL. THE SURGEON DRILLED A PILOT HOLE WITH A K-WIRE, AND HE COULD DRILL AND INSERT A SCREW. THE SURGEON DIDN'T KNOW CONCRETE MALFUNCTION OF THE DEVICES. IT WAS NOT REPORTED HOW THE SURGERY WAS COMPLETED. THE SURGICAL DELAY WAS UNKNOWN. CONCOMITANT DEVICES REPORTED: CONNECT-SCR-CANN F/PFN+PFNA (PART# 357.029, LOT# 2223477, QUANTITY#. THIS COMPLAINT INVOLVES SEVEN (7) DEVICES. THIS IS REPORT 3 OF 7 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9904362 ↗
• MalfunctionSep 17, 2019Device-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 PASSAGE OF THE SCREWS IN THE DISTAL PROTECTION SLEEVE WAS VERY DIFFICULT TO COMPLETE. THEY WERE UNABLE TO USE THE DEVICE FOR AN UNKNOWN PROCEDURE. NO PATIENT INFORMATION REPORTED. THIS REPORT IS FOR ONE (1) 11.0MM/8.0MM PROTECTION SLEEVE 188MM FOR ASLS THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9075526 ↗
• MalfunctionSep 17, 2019Device-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 PASSAGE OF THE SCREWS IN THE DISTAL PROTECTION SLEEVE WAS VERY DIFFICULT TO COMPLETE. THEY WERE UNABLE TO USE THE DEVICE FOR AN UNKNOWN PROCEDURE. NO PATIENT INFORMATION REPORTED. THIS REPORT IS FOR ONE (1) 11.0MM/8.0MM PROTECTION SLEEVE 188MM FOR ASLS THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9075520 ↗
• InjuryMay 24, 2019Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING TROCHANTERIC FEMORAL NAIL PROCEDURE, ONE (1) PROTECTION SLEEVE WOULD NOT SLIDE INTO ONE (1) AIMING ARM. PROTECTION SLEEVE WOULD NOT SLIDE ALL THE WAY THROUGH THE JIG AND IS NOW STUCK. THE PROCEDURE ENDED UP FREE HANDING FOR A PERFECT CIRCLE TO COMPLETE THE CASE. SURGEON LOST A PERFECT REDUCTION DUE TO X-RAY TEAM HAVING TO RE-POSITION THE PATIENT TO FREE HAND DRILL UNDER X-RAYS. THERE WAS A SURGICAL DELAY OF 1 HOUR AND 30 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS SUCCESSFUL/NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) PROTECTION SLEEVE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available

  MAUDE report 8641631 ↗
• MalfunctionFeb 20, 2018Failure to Align; Failure to Align

  IT WAS REPORTED THAT DURING A TFNA PROCEDURE ON (B)(6) 2017 A PHYSICIAN STRUGGLED TO GET A DISTAL LOCKING SCREW TO PASS THROUGH A SHORT TFNA NAIL. THE SCREW WAS NOT ENTERING INTO THE NAIL AT THE RIGHT ANGLE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING THE REPORTED DEVICES. THERE WAS NO REPORTED SURGICAL DELAY. THE PATIENT WAS REPORTED TO BE IN GOOD CONDITION FOLLOWING THE PROCEDURE. REPORTED CONCOMITANT DEVICES: UNKNOWN TFNA SHORT NAIL, LOT NUMBER UNKNOWN, QUANTITY 1. THIS REPORT INVOLVES (3) DEVICE. (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7284073 ↗