NA 359.213Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10886982197146), received between Jan 17, 2017 and Jan 8, 2026 — classified as 2 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 8, 2026Break

  THE TIP OF THE INSTRUMENT BROKE OFF DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24010295 ↗
• MalfunctionJun 28, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. NUMEROUS STAINS WERE ADHERING TO THE RUBBER PART OF SEVERAL PRODUCTS. THE INSTRUMENTATION NURSE, AT THE DISCRETION OF THE PRIMARY SURGEON, WIPED OFF THE STAINS WITH A TOWEL, AND THE SAID PRODUCTS WERE USED DURING THE SURGERY. IT WAS CONFIRMED THAT THE PRODUCTS WERE ALSO MORE WATER-REPELLENT THAN USUAL DURING POST-OPERATIVE CLEANING. THIS REPORT IS FOR ONE AWL F/TEN THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 19636874 ↗
• MalfunctionJun 28, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE INSTRUMENTS WERE BROKEN. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER DETAILS ARE AVAILABLE. THIS REPORT INVOLVES ONE AWL. THIS IS REPORT 5 OF 7 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17216716 ↗
• MalfunctionDec 7, 2022Failure to Cut; Failure to Cut

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT THE DEVICE DOES NOT HAVE A SHARP EDGE. THIS REPORT IS FOR ONE (1) AWL F/TEN THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15931057 ↗
• MalfunctionOct 17, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT ON(B)(6)2022 , THE ITEMS WERE BROKEN DURING A PROCEDURE. THERE WAS A SURGICAL DELAY OF 15 MINUTES AS A RESULT. ANOTHER KIT WAS OPENED TO COMPLETE THE PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE AWL. THIS IS REPORT 1 OF 5 FOR PC-(B)(4). .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15616535 ↗
• InjuryMay 17, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING AN UNKNOWN PROCEDURE, A BROWN SUBSTANCE LEAKED FROM THE INSTRUMENTS THAT RESULTED IN CONTAMINATION OF THE HAMMER, INSERTER AND AWL. THERE WAS A SURGICAL DELAY OF (30) MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING REPLACEMENT DEVICES. IT WAS STATED THAT THE PATIENT REQUIRED AN OPEN REDUCTION INTERNAL FIXATION PROCEDURE DUE TO THE INSTRUMENTS NOT BEING AVAILABLE. THIS REPORT IS FOR (1) AWL. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11837856 ↗
• InjuryJan 17, 2017Break; Break

  DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT IS WAS AN OPEN FRACTURE REDUCTION IN HUMERAL SHAFT WITH INTERNAL FIXATION. WHEN THE SPECIALIST PERFORMED THE PIERCING WITH THE PUNCH, THE TIP BROKE. NO PROLONGATION OF THE SURGERY WAS REPORTED. PATIENT STATUS IS NORMAL. THE PUNCTURE TIP, THAT WAS SPLIT, WAS INSIDE THE CHANNEL OF THE PATIENT'S BONE; HOWEVER, THE SPECIALIST STATED THAT IT DOES NOT REPRESENT ANY RISK TO THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. THIS COMPLAINT INVOLVES 1 PART. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient

  MAUDE report 6258797 ↗