NA 03.010.041Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982067142), received between Dec 21, 2016 and Apr 10, 2026 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2026Break

  IT WAS REPORTED ON (B)(6) 2026 THAT THE AWL HAS BROKEN TIP, AND THE INSERTION INSTRUMENT WAS BENT. NO OPERATION INVOLVED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24844748 ↗
• MalfunctionApr 8, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, AT THE TIME OF MAKING THE INITIAL CHANNEL TO THE INTRAMEDULLARY AREA, THE TIP OF THE PUNCH WAS BROKEN, BUT IT WAS MANAGED AND THE SURGERY WAS PERFORMED WITHOUT ANY PROBLEM. THIS REPORT IS FOR ONE AWL Ø14/3.2 CANN. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19060092 ↗
• MalfunctionOct 10, 2022Material Integrity Problem; Material Integrity Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN PORTUGAL AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT - 03.010.041 B 14.0/3.2 MM PUNZÓN, DAMAGED CANULATED. 03.010.063 HYSTIC PROTECTION PLANE 12.0/8.0, LONGITUD 188 MM, AND A 03.010.065 BIT GUIDE 8.0/4.2, FOR PART NO. 03.010.063, VERY DIFFICULT TO REMOVE FROM EACH OTHER. THERE WAS NO SURGICAL DELAY. THERE WAS ALTERATION OF THE TECHNIQUE BY ANOTHER SURGICAL OPTION EXISTING IN THE SURGICAL INSTRUMENT, WITH NO IMPACT ON THE SURGERY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR A 14.0MM CANNULATED AWL THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15573464 ↗
• InjurySep 29, 2020Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT INTRAMEDULLARY NAIL, DURING THE PROCEDURE, A PIECE OF THE CANNULATED AWL BROKE OFF IN THE GREATER TROCHANTER. FRAGMENTS WERE GENERATED. THE FRAGMENT WAS NOT ABLE TO BE REMOVED AND REMAINED IN THE PATIENT. THERE WAS NO SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT STATUS IS UNKNOWN. THIS REPORT INVOLVES ONE (1) 14.0MM CANNULATED AWL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Foreign Body In Patient; Injury

  MAUDE report 10599447 ↗
• InjuryMar 6, 2020Break; Break

  IT WAS REPORTED THAT DURING AN INTRAMEDULLARY (IM) NAILING OF THE FEMUR FOR ROTATIONAL OSTEOTOMY OF THE FEMUR ON (B)(6) 2020, WHILE GETTING THE STARTING POINT IN THE FEMUR FOR IM NAIL, THE TIP OF THE CANNULATED AWL BROKE OFF. IT TOOK ABOUT 30-40 MINUTES TO RETRIEVED THE BROKEN PIECE OUT OF THE PATIENT AS THE SURGEON HAD TO MAKE A LARGER INCISION IN ORDER TO ACCESS THE PIRIFORMIS FOSSA WHERE THE FRAGMENT WAS LODGE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE USE OF AN OPENING REAMER. PATIENT STATUS WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN GUIDEWIRE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 14.0MM CANNULATED AWL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available

  MAUDE report 9799810 ↗
• InjurySep 28, 2017Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A FEMORAL NAILING DUE TO A FOOTBALL INJURY. UPON OPENING THE PATIENT'S PROXIMAL FEMUR, IT WAS NOTED THAT HE HAD EXTREMELY HARD BONE SO THE SURGEON USED A 14.0 MM CANNULATED AWL AFTER THE OPENING REAMER WOULDN'T ADVANCE. AFTER SINKING THE 14.0 MM CANNULATED AWL IT WAS NOTED THAT A PIECE OF THE AWL BROKE OFF IN THE BONE. THE SURGEON DECIDED NOT TO RETRIEVE THE PIECE AND THE SURGERY WASN'T DELAYED. THEN, WHEN LOCKING THE NAIL PROXIMALLY, THE DRILL SLEEVES DIDN'T PASS THROUGH THE HANDLE EASILY, AND THEY WERE DIFFICULT TO REMOVE. THERE WASN'T A CONSIDERABLE DELAY DUE TO THIS, BUT THE SURGEON MENTIONED HOW DIFFICULT IT WAS TO PASS THE SLEEVES. CONCOMITANT DEVICE REPORTED: DRILL SLEEVES, UNKNOWN NAIL. THIS REPORT IS FOR ONE (1) 14.0 MM CANNULATED AWL. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6901821 ↗
• MalfunctionDec 21, 2016Break; Break

  IT WAS REPORTED THAT AN AWL WAS DISCOVERED BROKEN IN A STORAGE WAREHOUSE OUTSIDE OF HOSPITAL. NO PATIENT INVOLVEMENT WAS REPORTED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6193328 ↗