NA 323.055Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10886982190727), received between Oct 1, 2018 and Dec 22, 2023 — classified as 15 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (11 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 22, 2023Material Deformation; Material Deformation

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON 01-DECEMBER-2023, THE FOUR K-WIRE SLEEVES IN QUESTION WERE FOUND TO BE DEFORMED. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. THIS REPORT IS FOR A 1.6MM WIRE SLEEVE. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18388001 ↗
• MalfunctionDec 21, 2023Material Deformation; Material Deformation

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE FOUR K-WIRE SLEEVES IN QUESTION WERE FOUND TO BE DEFORMED. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. THIS REPORT IS FOR A 1.6MM WIRE SLEEVE. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18379396 ↗
• MalfunctionDec 21, 2023Material Deformation; Material Deformation

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE FOUR K-WIRE SLEEVES IN QUESTION WERE FOUND TO BE DEFORMED. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. THIS REPORT IS FOR A 1.6MM WIRE SLEEVE. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18379211 ↗
• MalfunctionDec 21, 2023Material Deformation; Material Deformation

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON 01-DECEMBER-2023, THE FOUR K-WIRE SLEEVES IN QUESTION WERE FOUND TO BE DEFORMED. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. THIS REPORT IS FOR A 1.6MM WIRE SLEEVE. THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18377968 ↗
• MalfunctionOct 19, 2022Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE K-WIRE SLEEVE IN QUESTION WAS BENT WHEN IT WAS DELIVERED. THE SLEEVE WAS PREPARED FOR SURGERY ON (B)(6) 2022. A SUBSTITUTE SLEEVE WAS TO BE ARRANGED TO COMPLETE THE OSTEOSYNTHESIS FOR CLAVICLE AND SCAPULA FRACTURE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE 1.6MM WIRE SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15634342 ↗
• MalfunctionJan 15, 2021Material Deformation

  IT WAS REPORTED THAT UPON ROUTINE INSPECTION OF THE OFFICE LOANER ON (B)(6) 2020, THE TWO 1.6MM WIRE SLEEVES WERE FOUND TO BE BENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A 1.6MM WIRE SLEEVE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11178910 ↗
• MalfunctionJan 15, 2021Material Deformation

  IT WAS REPORTED THAT UPON ROUTINE INSPECTION OF THE OFFICE LOANER ON (B)(6) 2020, THE TWO 1.6MM WIRE SLEEVES WERE FOUND TO BE BENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A 1.6MM WIRE SLEEVE. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11178883 ↗
• MalfunctionJan 13, 2020Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE ORTHOKIT TECHNICIAN REPORTS THAT DURING THE CHECKING , THEY DISCOVERED THAT FOUR NEW BROACHES GUIDES WERE CURVED. THE CURVE IS VISIBLE TO THE NAKED EYE AND CAUSES INCONVENIENCE WHEN HE HAD PASSED THE BROACHES INSIDE. THIS REPORT IS FOR ONE (1) 1.6MM WIRE SLEEVE. THIS IS REPORT 4 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9581112 ↗
• MalfunctionJan 13, 2020Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE ORTHOKIT TECHNICIAN REPORTS THAT DURING THE CHECKING , THEY DISCOVERED THAT FOUR NEW BROACHES GUIDES WERE CURVED. THE CURVE IS VISIBLE TO THE NAKED EYE AND CAUSES INCONVENIENCE WHEN HE HAD PASSED THE BROACHES INSIDE. THIS REPORT IS FOR ONE (1) 1.6MM WIRE SLEEVE THIS IS REPORT 3 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9581109 ↗
• MalfunctionJan 13, 2020Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE ORTHOKIT TECHNICIAN REPORTS THAT DURING THE CHECKING , THEY DISCOVERED THAT FOUR NEW BROACHES GUIDES WERE CURVED. THE CURVE IS VISIBLE TO THE NAKED EYE AND CAUSES INCONVENIENCE WHEN HE HAD PASSED THE BROACHES INSIDE. THIS REPORT IS FOR ONE (1) 1.6MM WIRE SLEEVE. THIS IS REPORT 2 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9581102 ↗
• MalfunctionJan 13, 2020Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE ORTHOKIT TECHNICIAN REPORTS THAT DURING THE CHECKING , THEY DISCOVERED THAT FOUR NEW BROACHES GUIDES WERE CURVED. THE CURVE IS VISIBLE TO THE NAKED EYE AND CAUSES INCONVENIENCE WHEN HE HAD PASSED THE BROACHES INSIDE. THIS REPORT IS FOR ONE (1) 1.6MM WIRE SLEEVE. THIS IS REPORT 1 OF 4 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9581087 ↗
• MalfunctionAug 22, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING ROUTINE INCOMING INSPECTION OF A LOANER SET, IT WAS OBSERVED THAT A WIRE SLEEVE WAS BENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 1.6 MM WIRE SLEEVE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8921089 ↗
• MalfunctionAug 22, 2019Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A ROUTINE INCOMING INSPECTION OF LOANER SET, THE WIRE SLEEVE WAS OBSERVED BENT. THERE WAS NO KNOWN HOSPITAL OR PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) 1.6 MM WIRE SLEEVE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8921079 ↗
• MalfunctionOct 2, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE DURING CLEANING, DECONTAMINATION AND FOLLOWING FUNCTIONAL TESTING THE CENT-SLEEVE WAS FOUND BROKEN. NO PATIENT INVOLVEMENT REPORTED. THIS REPORT IS FOR ONE (1) 1.6MM WIRE SLEEVE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7925413 ↗
• MalfunctionOct 1, 2018Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING DECONTAMINATION ON (B)(6) 2018, THE DEVICE WAS FOUND CURVED. THIS REPORT IS FOR ONE (1) 1.6MM WIRE SLEEVE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7924559 ↗