NA 03.045.019Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 10886982296122), received between Sep 17, 2021 and May 7, 2026 — classified as 29 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (24 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 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 7, 2026Device-Device Incompatibility

  WHEN DRILLING THE PROXIMAL MEDIAL TO LATERAL HOLES ON THE NAIL, THE CARBON FIBER AIMING ARM WAS MISALIGNED, LEADING TO A FAIL IN DRILLING USING THE INSTRUMENTATION. THIS CAUSED DELAY IN SURGERY TIME. NO COMPLICATIONS FOR PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25112114 ↗
• MalfunctionJan 22, 2026Device-Device Incompatibility

  IT WAS REPORTED DURING AN ADVANCED TIBIAL NAIL PROCEDURE, THE PROXIMAL DRILL GUIDE JIG FAILED THE ALIGNMENT FOR THE PROXIMAL SCREWS. THE TABLE ALIGNMENT TEST WAS SUCCESSFULLY DONE PRIOR TO INSERTING THE NAIL IN THE PATIENT. THE ISSUE CAUSED A SLIGHT SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24144414 ↗
• MalfunctionOct 15, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT OSTEOSYNTHESIS FOR FEMORAL TROCHANTERIC FRACTURES. DURING THE PRELIMINARY DRY CHECK, THERE WAS INTERFERENCE WITH THE DRILL WHEN INSERTING THE TFNA 130°-260MM LEFT LONG USING THE 260 DISTAL AIMING DEVICES. EVEN DURING ADJUSTMENT, THE DRILL BIT INTERFERED WITH THE PROXIMAL SIDE OF THE MOST PROXIMAL HOLE IN THE NAIL. FURTHERMORE, THERE WAS INTERFERENCE WHEN THE DEVICES WERE LOCKED AFTER ADJUSTMENT, LEADING TO SUSPICION THAT THERE MAY BE A MALFUNCTION IN THE DEVICES. AFTER ADJUSTMENT DURING THE DRY CHECK BEFORE INSERTION THERE WAS NO INTERFERENCE, BUT WHEN THE DEVICES WERE LOCKED, INTERFERENCE OCCURRED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES OF DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23280891 ↗
• MalfunctionOct 15, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT OSTEOSYNTHESIS FOR FEMORAL TROCHANTERIC FRACTURES. DURING THE PRELIMINARY DRY CHECK, THERE WAS INTERFERENCE WITH THE DRILL WHEN INSERTING THE TFNA 130°-260MM LEFT LONG USING THE 260 DISTAL AIMING DEVICES. EVEN DURING ADJUSTMENT, THE DRILL BIT INTERFERED WITH THE PROXIMAL SIDE OF THE MOST PROXIMAL HOLE IN THE NAIL. FURTHERMORE, THERE WAS INTERFERENCE WHEN THE DEVICES WERE LOCKED AFTER ADJUSTMENT, LEADING TO SUSPICION THAT THERE MAY BE A MALFUNCTION IN THE DEVICES. AFTER ADJUSTMENT DURING THE DRY CHECK BEFORE INSERTION THERE WAS NO INTERFERENCE, BUT WHEN THE DEVICES WERE LOCKED, INTERFERENCE OCCURRED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES OF DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23280765 ↗
• MalfunctionJul 17, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE TROCARS ARE BEING DEEMED "NOT STERILE" BECAUSE OF WEAR AND TEAR. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22532841 ↗
• MalfunctionJul 17, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE TROCARS ARE BEING DEEMED "NOT STERILE" BECAUSE OF WEAR AND TEAR. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22532680 ↗
• MalfunctionJul 17, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE TROCARS ARE BEING DEEMED "NOT STERILE" BECAUSE OF WEAR AND TEAR. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22532612 ↗
• MalfunctionJul 17, 2025Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT THE TROCARS ARE BEING DEEMED "NOT STERILE" BECAUSE OF WEAR AND TEAR. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22532563 ↗
• MalfunctionJan 31, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THERE WAS A PROBLEM WITH DRILLING A HOLE FOR THE LOCKING SCREW DUE TO PRESSURE ON THE AIMING ARM SYSTEM. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY. THE SURGEON STATED THEY REPEATEDLY CAME ACROSS THE NAIL WHILE DRILLING. THE DRILLING OF THE OBLIQUE LOCK WAS NOT A PROBLEM, THE PROBLEM WAS WITH THE CONNECTION BETWEEN THE TARGET BAR AND THE NAIL. IT COULD ONLY BE RELEASED FROM THE NAIL WITH EXTREME EXERTION AT THE END. IN THE SURGEON'S OPINION, IT WAS INITIALLY CORRECTLY MOUNTED, WHICH COULD HAVE CONTRIBUTED TO THE PROBLEM, THAT THEY LOWERED THE LEG FOR THE DISTAL, OBLIQUE LOCKING, THAT IS, THE KNEE STRETCHED AND THUS CERTAINLY BROUGHT TENSION TO THE CONNECTION NAIL/TARGET BRACKET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21283652 ↗
• MalfunctionJan 8, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6)2024, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY FOR AN INTERTROCHANTERIC FRACTURE. THE SURGEON DRILLED THE MOST PROXIMAL HOLE AMONG THE DISTAL SCREW HOLES. THE DRILL BIT INTERFERED WITH THE HOLE. THE SURGEON CHECKED THE SIDES AND WAS ABLE TO INSERT THE DRILL BIT, SO THE SURGEON LEFT THE DRILL BIT IN PLACE. THE SURGEON DRILLED THE MOST DISTAL OBLIQUE LOCKING HOLE. THERE WAS NO INTERFERENCE BETWEEN A DRILL BIT AND THE OBLIQUE LOCKING HOLE, AND INSERTION OF A LOCKING SCREW WAS COMPLETED. THE SURGEON REMOVED THE DRILL BIT THAT WAS LEFT IN THE MOST PROXIMAL HOLE AMONG THE DISTAL SCREW HOLES AND INSERTED A LOCKING SCREW. THE SURGEON DRILLED THE DYNAMIC HOLE, WHICH IS THE HOLE IN THE MIDDLE. THE DRILL BIT INTERFERED WITH THE DYNAMIC HOLE. THE SURGEON DID NOT INSERT A LOCKING SCREW TO THE DYNAMIC HOLE AND COMPLETED THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN A THIRTY (30) MINUTE DELAY. PER THE SURGEON, IT WAS PRESUMED THAT THERE WAS RESISTANCE DURING NAIL INSERTION AND THAT THERE MAY NOT HAVE BEEN ENOUGH MEDULLARY REAMING; THERE WAS NO ALLEGATION AGAINST THE NAIL OR SCREWS. THE PATIENT OUTCOME WAS REPORTED AS STABL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21103430 ↗
• MalfunctionJan 8, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY FOR AN INTERTROCHANTERIC FRACTURE. THE SURGEON DRILLED THE MOST PROXIMAL HOLE AMONG THE DISTAL SCREW HOLES. THE DRILL BIT INTERFERED WITH THE HOLE. THE SURGEON CHECKED THE SIDES AND WAS ABLE TO INSERT THE DRILL BIT, SO THE SURGEON LEFT THE DRILL BIT IN PLACE. THE SURGEON DRILLED THE MOST DISTAL OBLIQUE LOCKING HOLE. THERE WAS NO INTERFERENCE BETWEEN A DRILL BIT AND THE OBLIQUE LOCKING HOLE, AND INSERTION OF A LOCKING SCREW WAS COMPLETED. THE SURGEON REMOVED THE DRILL BIT THAT WAS LEFT IN THE MOST PROXIMAL HOLE AMONG THE DISTAL SCREW HOLES AND INSERTED A LOCKING SCREW. THE SURGEON DRILLED THE DYNAMIC HOLE, WHICH IS THE HOLE IN THE MIDDLE. THE DRILL BIT INTERFERED WITH THE DYNAMIC HOLE. THE SURGEON DID NOT INSERT A LOCKING SCREW TO THE DYNAMIC HOLE AND COMPLETED THE SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN A THIRTY (30) MINUTE DELAY. PER THE SURGEON, IT WAS PRESUMED THAT THERE WAS RESISTANCE DURING NAIL INSERTION AND THAT THERE MAY NOT HAVE BEEN ENOUGH MEDULLARY REAMING; THERE WAS NO ALLEGATION AGAINST THE NAIL OR SCREWS. THE PATIENT OUTCOME WAS REPORTED AS STAB

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21103390 ↗
• MalfunctionApr 3, 2024Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE EVENT OCCURRED INTRAOPERATIVELY. THERE WAS SURGICAL DELAY BUT THE DURATION IS UNKNOWN. THE SURGERY WAS SUCCESSFULLY COMPLETED BUT A BROKEN DRILL BIT WAS NOT RETRIEVED. PATIENT OUTCOME IS REPORTED AS FINE. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19032679 ↗
• MalfunctionJan 19, 2024Device-Device Incompatibility; Device-Device Incompatibility

  THERE WAS NO SURGICAL DELAY. THE SURGERY WAS SUCCESSFULLY COMPLETED. THE PATIENT STATUS IS REPORTABLE AS STABLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18542642 ↗
• MalfunctionJan 17, 2024Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLUMBIA AS FOLLOWS: IT WAS REPORTED THAT THE 11/8 SLEEVE PROTECTION GETS STUCK IN SURGERY WITH DRILL SL 4.2 AND SYREAM 2.5 L950 DRILL GUIDE AND BENDS IN SURGERY. NO OTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) PROTECTION SLEEVE Ø11/8. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18529133 ↗
• MalfunctionJun 5, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023 WHERE A RFNA WAS INSERTED, WAS MALLETING IN WITH SLEEVE IN JIG. SLEEVES WERE NOT ABLE TO BE DRILLED THROUGH BECAUSE IT HIT NAIL AND THEY WERE STUCK. UNABLE TO TAKEN OUT - MALLET ALSO WAS CHIPPED IN PROCESS. NAIL WAS NOT BILLED. THERE WAS NO SURGICAL DELAY. THERE WERE NO PATIENT OUTCOME OR CONSEQUENCES. THIS REPORT IS FOR ONE (1)PROTECTION SLEEVE/ 11/8 THIS IS REPORT 6 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17061130 ↗
• MalfunctionJun 5, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023 WHERE A RFNA WAS INSERTED, WAS MALLETING IN WITH SLEEVE IN JIG. SLEEVES WERE NOT ABLE TO BE DRILLED THROUGH BECAUSE IT HIT NAIL AND THEY WERE STUCK. UNABLE TO TAKEN OUT - MALLET ALSO WAS CHIPPED IN PROCESS. NAIL WAS NOT BILLED. THERE WAS NO SURGICAL DELAY. THERE WERE NO PATIENT OUTCOME OR CONSEQUENCES. THIS REPORT IS FOR ONE (1)PROTECTION SLEEVE/ 11/8. THIS IS REPORT 2 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17060118 ↗
• MalfunctionMar 10, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6), 2023 WHEN DRILLING FOR SCREW PLACEMENT IN THE PROXIMAL END OF THE ANS TIBIA NAIL, THE MOST DISTAL SCREW (IN THE PROXIMAL SECTION) THE DRILL BIT HIT THE NAIL AND DIDN¿T PASS THROUGH THE NAIL. IN ADDITION, THE TNA AIMING ARM DOES NOT APPEAR TO LINE UP WITH THE NAIL PROPERLY. WHEN DRILLING THE PROXIMAL STATIC MEDIAL TO LATERAL SCREW, THE 4.2 DRILL BIT WAS HITTING THE NAIL INSTEAD OF THE HOLE IN THE NAIL. THERE WAS A MILD DELAY IN SURGERY. THE SURGEON DECIDED TO NOT USE THE HOLE THAT THE DRILL BIT WAS MISSING AND MOVED ON TO ANOTHER HOLE IN THE NAIL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, NO FRAGMENTS WERE GENERATED. IT WAS UNKNOWN IF THERE WAS ANY PATIENT OUTCOME/CONSEQUENCES. THIS REPORT IS FOR ONE (1) PROTECTION SLEEVE/ Ø 11/8. THIS IS REPORT 6 OF 7 FOR COMPLAINT#: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16521304 ↗
• MalfunctionFeb 24, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, DRILL BIT WAS HITTING THE NAIL (DISTAL, TRANSVERSE HOLE) WHILE USING THE AIMING ARM FOR PROXIMAL SCREWS. FAULTY TARGETING, WHICH INVOLVES THE INSERTION HANDLE, AIMING ARM, CONNECTING SCREW, AND TROCARS. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH 15 MINUTES SURGICAL DELAY. NO PATIENT WAS HARMED. THIS REPORT IS FOR ONE (1) PROTECTION SLEEVE/ 11/8. THIS IS REPORT 7 OF 10 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16436850 ↗
• MalfunctionFeb 24, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2023, DRILL BIT WAS HITTING THE NAIL (DISTAL, TRANSVERSE HOLE) WHILE USING THE AIMING ARM FOR PROXIMAL SCREWS. FAULTY TARGETING, WHICH INVOLVES THE INSERTION HANDLE, AIMING ARM, CONNECTING SCREW, AND TROCARS. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH 15 MINUTES SURGICAL DELAY. NO PATIENT WAS HARMED. THIS REPORT IS FOR ONE (1) PROTECTION SLEEVE/ 11/8. THIS IS REPORT 5 OF 10 FOR COMPLAINT(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16436470 ↗
• MalfunctionJan 6, 2023Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE SALES REP NOTIFIED THAT THE DISTAL SCREWS MISSED THE NAIL THROUGH J-AIMING ARM RADIOLUCENT, WHILE USING THE INSERTION HANDLE RADIOLUCENT ARM. THERE IS ALSO AN ISSUE WITH THE CONNECTING SCREWS. IT WAS UNKNOWN WHETHER THERE WAS ANY PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A PROTECTION SLEEVE/ Ø 11/8. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16112303 ↗
• MalfunctionNov 21, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, THAT THEY HAD AN ISSUE WITH THE RETROGRADE FEMORAL NAIL ADVANCED SYSTEM AIMING ARM NOT TARGETING THE NAIL CORRECTLY. THE DRILL BIT MISSED THE DISTAL TRANSVERSE HOLE IN THE NAIL. NO ADDITIONAL INFORMATION WAS REPORTED. THIS REPORT IS FOR ONE (1) PROTECTION SLEEVE/ 11/8 THIS IS REPORT 6 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15838730 ↗
• MalfunctionNov 21, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON OCTOBER 31,2022, THAT THEY HAD AN ISSUE WITH THE RETROGRADE FEMORAL NAIL ADVANCED SYSTEM AIMING ARM NOT TARGETING THE NAIL CORRECTLY. THE DRILL BIT MISSED THE DISTAL TRANSVERSE HOLE IN THE NAIL. NO ADDITIONAL INFORMATION WAS REPORTED. THIS REPORT IS FOR ONE (1) PROTECTION SLEEVE/ 11/8. THIS IS REPORT 3 OF 8 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15838059 ↗
• MalfunctionSep 16, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, THERE WAS AN ISSUE WITH THE NEW TIBIAL NAIL ADVANCED SYSTEM. DURING THE SURGICAL CASE, THE PROXIMAL HARDENING WAS MISSING, SO THE SLEEVE AND TROCHAR ASSEMBLY GOING THROUGH THE AIMING ARM WAS NOT TARGETED CORRECTLY. THE DRILL BIT WAS HIDDEN IN THE NAIL AND DID NOT GO THROUGH THE HOLE IN THE NAIL. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME WERE UNKNOWN. THIS REPORT INVOLVES ONE PROTECTION SLEEVE/ Ø 11/8. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15439729 ↗
• MalfunctionSep 12, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING SUPRAPATELLAR INSERTION OF AN ADVANCED NAILING SYSTEM (ANS), TIBIA NAIL ADVANCED (TNA) INTRAMEDULLARY NAIL, THE SURGEON WAS NOT ABLE TO PUT A 5.0MM INTERLOCK IN THE MOST DISTAL PROXIMAL STATIC INTERLOCK. THIS WAS THE MOST DISTAL OF THE PROXIMAL INTERLOCKS THAT ARE TARGETED THROUGH THE AIMING ARM. THEY ATTEMPTED TO RELIEVE FROM PRESSURE ON THE SYSTEM BY PLACING A BUMP UNDER THE PATIENT¿S KNEE, PUTTING THE KNEE INTO MORE OF A FLEXED POSITION BUT THE LONG 4.2MM DRILL BIT WAS STILL HITTING THE NAIL AND NOT GOING THROUGH THE INTERLOCK HOLE. THEY WERE EVENTUALLY ABLE TO FIND THE CORRECT PATH BY STARTING WITH A LONG 3.2MM DRILL BIT, THEN DRILLING WITH THE LONG 4.2MM DRILL BIT. BUT WHEN THEY WENT TO INSERT THE 5.0MM INTERLOCK THE SCREW ONLY MADE IT THROUGH THE NEAR CORTEX AND WAS SPINNING, LIKELY CONTACTING THE NAIL OR FAR CORTEX INSTEAD OF PASSING THROUGH THE DRILLED HOLE. THEY WERE NOT ABLE TO PUT AN INTERLOCK THROUGH THIS HOLE AND HAD TO USE A PROXIMAL OBLIQUE INSTEAD. PROXIMAL TARGETED SCREW INSERTION THROUGH THE AIMING ARM AND LONG INSERTION HANDLE WAS OFF. THE DRILL BIT WAS HITTING THE NAIL INSTEAD OF GOING THROUGH THE INTERLOCK HOLE IN THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15402956 ↗
• MalfunctionMar 17, 2022Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING THE POST OP INSPECTION OF OUTER AND INNER SLEEVE WAS FOUND STRIPPED, WHEN TRYING TO THREAD IN INNER SLEEVE. MEASURING DEPTH GAUGE WAS STARTING TO FADE NUMBERS, ALONG WITH STRIPPED TIP OF GUIDE DUE TO VOLUME OF USAGE. THERE WAS NO KNOWN PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) PROTECTION SLEEVE/ Ø 11/8. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13801313 ↗