NA 03.010.491Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10886982069085), received between Feb 14, 2017 and Jun 22, 2026 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Break” (22 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 22, 2026Break

  IT WAS REPORTED THAT WHEN UTILIZING THE ANS BASE INSTRUMENT SET AND THE TFNA STANDARD SETS, THEY HAD NUMEROUS ITEMS BREAK/BECOME FAULTY THAT DELAYED THE SURGERY SUBSTANTIALLY. THESE ITEMS NOT WORKING PROPERLY/BREAKING DURING THE PROCEDURE CAUSED ROUGHLY A 15 MINUTE DELAY WITH THE PROCEDURE, AND HAD TO BE REMOVED FROM SERVICE. NO FRAGMENTS WERE LEFT INSIDE THE PATIENT, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THEY HAD TO TAKE ROUGHLY 10-15 SECONDS ADDITIONAL OF FLUOROSCOPY TO ASSIST WITH THIS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25579747 ↗
• MalfunctionJun 19, 2026Break

  IT WAS REPORTED THAT WHEN UTILIZING THE ANS BASE INSTRUMENT SET AND THE TFNA STANDARD SETS, NUMEROUS ITEMS BROKE/BECAME FAULTY THAT CAUSED ROUGHLY A 15 MINUTES OF SURGICAL DELAY. THESE ITEMS NOT WORKING PROPERLY/BREAKING DURING THE PROCEDURE AND HAD TO BE REMOVED FROM SERVICE. NO FRAGMENTS WERE LEFT INSIDE THE PATIENT, AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ADDITIONAL 10-15 SECONDS FLUOROSCOPY WAS REQUIRED TO ASSIST WITH THE PROCEDURE. THERE WAS NO PATIENT HARM. ADDITIONAL IMPACTED PRODUCTS ARE CAPTURED UNDER RELATED COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25567416 ↗
• MalfunctionMay 6, 2026Break

  IT WAS REPORTED THAT THE INSTRUMENT BROKE AT THE TIP DURING SURGERY. THERE WAS NO ADVERSE PATIENT INVOLVEMENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND NO FRAGMENTS WERE GENERATED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25094788 ↗
• MalfunctionDec 10, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE LONG HANDLE SCALPEL WAS BROKEN DURING THE CASE. I WAS NOT MADE AWARE UNTIL AFTER THE CASE. THE SCRUB TECH DID NOT KNOW HOW IT BROKE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20892161 ↗
• MalfunctionMar 18, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHILE CLEANING UP THE INSTRUMENTS POST-OP THAT THE LONG KNIFE HANDLE FROM THE TFNA SET WAS DROPPED BY THE SURGICAL TECH AND THE TIP SNAPPED OFF. THIS HAPPENED POST-OP AND THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) LONG SCALPEL HANDLE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18924002 ↗
• MalfunctionMar 11, 2024Break; Break

  IT WAS REPORTED THAT PART WHERE THE KNIFE BLADE ATTACHES, BROKE OFF. THIS REPORT IS FOR ONE (1) LONG SCALPEL HANDLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18874765 ↗
• MalfunctionOct 31, 2023Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TIP OF THE KNIFE HANDLE BROKE OFF. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) LONG SCALPEL HANDLE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18038607 ↗
• MalfunctionJun 7, 2023Break; Break

  IT WAS REPORTED, THAT ON AN UNKNOWN DATE. A LIST OF BROKEN ITEMS COLLECTED FROM THE SPD OF ACCOUNTS IN T241. ALL ITEMS WERE DISCOVERED, BROKEN AT POST-OP AND DID NOT EFFECT SURGICAL CAPABILITIES. REPLACEMENT NEEDED. THIS REPORT IS FOR ONE (1) LONG SCALPEL HANDLE. THIS IS REPORT 9 OF 12 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17079027 ↗
• MalfunctionMar 3, 2023No Apparent Adverse Event; No Apparent Adverse Event

  THE FOLLOWING DEVICE WAS RECEIVED AS BLIND UNIT FOR THE FOLLOWING PRODUCTS: IT WAS REPORTED THAT THE VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT LONG SCALPEL HANDLE WAS BROKEN FROM THE TIP. THE BROKEN FRAGMENT WAS NOT RETURNED FOR EXAMINATION. NO OTHER ISSUES WERE FOUND. NO ADDITIONAL INFORMATION IS KNOWN. HOWEVER, IT COULDN¿T BE ASSOCIATED WITH A COMPLAINT OR ANY OTHER EXISTING RECORD. THIS COMPLAINT INVOLVES SIX (6) DEVICES. THIS REPORT IS FOR ONE (1) LONG SCALPEL HANDLE. THIS IS REPORT 3 OF 6 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16482392 ↗
• MalfunctionDec 12, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN DENMARK AS FOLLOWS: IT WAS REPORTED THE LONG SCALPEL HANDLE BROKE. THIS REPORT IS FOR A LONG SCALPEL HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15958658 ↗
• MalfunctionNov 9, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THE DEVICE WAS BROKEN. NO PATIENT WAS INVOLVED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE LONG SCALPEL HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15758635 ↗
• MalfunctionAug 31, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE ORIF SURGERY WITH TFNA IMPLANTS FOR TROCHANTERIC FRACTURE OF FEMUR. INSIDE THE PATIENT'S BODY, A SCALPEL BLADE BECAME DETACHED FROM THE HANDLE WHEN THE SURGEON WAS MAKING AN INCISION FOR INSERTING A HEAD ELEMENT. ALMOST NO IMPACT ON SURGERY TIME BECAUSE THE SCALPEL BLADE COULD HAVE BEEN REMOVED IMMEDIATELY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THE PATIENT IS IN STABLE CONDITION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) HANDLE F/SCALPEL LONG. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15327285 ↗
• MalfunctionJul 21, 2021Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2021, TWO (2) STAR/HEX DRIVE SCREWDRIVER, ONE (1) DRIVING CAP/THREADED, ONE (1) LONG SCALPEL HANDLE, ONE (1) CANNULATED HEXAGONAL SCREWDRIVER, AND ONE (1) HEXAGONAL SCREWDRIVER WERE DAMAGED PRODUCTS. IT IS UNKNOWN IF THERE WERE PATIENT AND PROCEDURE INVOLVEMENT. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) LONG SCALPEL HANDLE. THIS IS REPORT 4 OF 6 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12204049 ↗
• MalfunctionMay 24, 2021Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE KNIFE HANDLE WAS FOUND BROKEN WHILE ASSEMBLING THE SET. THE KNIFE HANDLE WAS NO USED DURING THE CASE. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) LONG SCALPEL HANDLE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11871858 ↗
• MalfunctionMar 8, 2021Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2021, DURING SURGERY SET-UP, THE SCRUB TECH ATTEMPTED ASSEMBLY OF KNIFE BLADE ONTO LONG SCALPEL HANDLE AND THE TIP BROKE OFF. THE INSTRUMENT AND BROKEN TIP WERE REMOVED FROM THE STERILE FIELD. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) LONG SCALPEL HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11439486 ↗
• MalfunctionJan 21, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE LONG SCALPEL HANDLE WAS DROPPED ON THE FLOOR AND THE TIP BROKE OFF. IT IS UNKNOWN WHEN AND WHERE THE ISSUE WAS DISCOVERED. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) LONG SCALPEL HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4)..

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11207925 ↗
• MalfunctionJul 20, 2020Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2020, THE LONG SCALPEL HANDLE WAS BROKEN. THE ISSUE OCCURRED WHEN THE REPORTED DEVICE WAS DROPPED IN STERILE PROCESSING DEPARTMENT (SPD). THERE WERE NO PATIENT AND SURGICAL INVOLVEMENT. THIS COMPLAINT INVOLVES 1 DEVICE. THIS REPORT IS FOR (1) LONG SCALPEL HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10298231 ↗
• MalfunctionMay 12, 2020Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A BREAK ON THE TIP OF A LONG HANDLE SCALPEL OCCURRED DURING CLEANING AFTER USE. THERE WAS NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) LONG SCALPEL HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 10049357 ↗
• MalfunctionApr 19, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, THE METAL TIP OF THE LONG SCALPEL HANDLE BROKE OFF DURING THE PERIOD BETWEEN COMPLETION OF A TROCHANTERIC FEMORAL NAIL ADVANCED (TFNA) SURGICAL PROCEDURE AND THE WASHING/STERILIZATION PERIOD AT THE HOSPITAL. IT IS UNKNOWN HOW THIS PART WAS BROKEN OFF, AND THE BROKEN TIP COULD NOT BE FOUND. THERE WAS NO POST-OPERATIVE DEVICE MALFUNCTION AND NO ADVERSE EVENTS REPORTED. PROCEDURE OUTCOME IS UNKNOWN. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8531512 ↗
• MalfunctionFeb 27, 2019Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, DURING FIELD INSPECTION AT THE STERILE PROCESSING DEPARTMENT (SPD), IT WAS NOTICED THAT THE END OF YELLOW LONG SCALPEL HANDLE HOLDER WAS BROKEN OFF. THE BROKEN OFF PIECE WAS NOT FOUND IN THE SET. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) LONG SCALPEL HANDLE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8374799 ↗
• MalfunctionFeb 7, 2019Break; Break

  IT WAS REPORTED ON (B)(6) 2019, THE LONG SCALPEL HANDLE WAS CAUGHT IN HOLES OF GRAPHIC CASE AND THE TIP BROKE OFF WHEN A STERILIZATION TECHNICIAN ATTEMPTED TO REMOVE IT. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICE REPORTED: UNKNOWN GRAPHIC CASE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8317031 ↗
• MalfunctionJan 14, 2019Break; Break

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2018, BEFORE AN UNKNOWN SURGERY, THE HOSPITAL FOUND THAT THE TIP OF THE SCALPEL HANDLE WAS BROKEN. THE HANDLE WAS NOT USED IN THE SURGERY. IT IS UNKNOWN HOW THE ISSUE WAS DISCOVERED. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT IS FOR A SCALPEL HANDLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8245447 ↗
• MalfunctionFeb 14, 2017Break; Break

  IT WAS REPORTED THAT THE TIP OF THE LONG SCALPEL HANDLE BROKE OFF. THE BREAKAGE OCCURRED DURING STERILIZATION. THERE WAS NO PROCEDURE OR PATIENT INVOLVEMENT. THERE IS AN INDENTATION ON THE SHAFT OF THE DEVICE THAT NARROWS DOWN TO A TIP. THE BREAKAGE OCCURRED AT THE INDENTATION AND THE TIP OF THE DEVICE BROKE OFF. THIS REPORT IS FOR ONE (1) LONG SCALPEL HANDLE. THIS IS REPORT 1 OF 1 FOR COM-(B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6329960 ↗