NA 391.105Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10886982198136), received between Jan 17, 2018 and May 21, 2021 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2021Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, THE NON-ACCEPTANCE OF THE INSTRUMENT WITH CABLE IN CELERON MATERIAL BY THE (B)(6) HOSPITAL MATERIALS CENTER, WE CONSULTED WITH NURSE (B)(6), RESPONSIBLE FOR THE TECHNICAL AREA OF THE HOSPITAL'S MATERIALS CENTER. IT IS A MATERIAL THAT HAS POROSITY DUE TO EXPOSURE TO THE TEMPERATURE OF THE STERILIZATION PROCESS. IT IS THE POROSITY OF THE CELERON THAT COMPROMISES THE CLEANING PROCESS. IT WAS UNDERSTOOD THEN THAT THE MATERIAL COMPROMISES THE STERILIZATION PROCESS, SINCE IT HAS POROSITY THAT DOES NOT GUARANTEE THE EFFECTIVENESS OF CLEANING. IF YOU ARE NOT IN ACCORDANCE WITH THE JUSTIFICATION PRESENTED, I SUGGEST THAT YOU PRESENT TO THE HOSPITAL TECHNICIANS RESPONSIBLE, A DOCUMENT WITH THE MANUFACTURER'S SPECIFICATIONS THAT MEET THE STANDARDS OF THE MANUALS OF GOOD CLEANING AND STERILIZATION PRACTICES. THIS REPORT IS FOR ONE (1) MEDIUM CABLE PASSER. THIS IS REPORT 13 OF 15 FOR COMPLAINT (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11866493 ↗
• MalfunctionFeb 28, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, AN UNKNOWN SURGERY FOR THE FEMORAL TROCHANTERIC FRACTURE WAS PERFORMED WITH TWO (2) CABLE PASSERS. DURING THE SURGERY, THE SURGEON COULD NOT THREAD THE CABLES INTO THE PASSERS' HOLE. SUBSEQUENTLY, A BLACKISH BROWN COLORED FOREIGN MATERIAL CAME OUT FROM THE HOLES OF PASSERS. THE SURGEON SUSPECTED THE INSUFFICIENCY OF THE CLEANING BEFORE THE DEVICE WAS SHIPPED. THE SURGERY WAS DELAYED BY LESS THAN 30 MINUTES. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICE: CABLE (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1) . THIS REPORT IS FOR ONE (1) CABLE PASSER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8378866 ↗
• MalfunctionJan 4, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, A BROWN LIQUID WAS LEAKING FROM THE FERROCELL HANDLE OF FIVE (5) CABLE PASSERS (DIFFERENT SIZES) AT THE CLEANING AND STERILIZATION PROCESS. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) MEDIUM CABLE PASSER. THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8219548 ↗
• MalfunctionJan 17, 2018Fluid/Blood Leak; Device Contamination with Chemical or Other Material; Fluid/Blood Leak; Device Contamination with Chemical or Other Material

  DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: WHEN THE REPORTED CAB-1 (THE NAME OF THE SURGICAL TOOL SET ASSORTED IN (B)(6)) WAS ABOUT BEING WASHED POSTOPERATIVELY, IT WAS FOUND THAT SOME BROWN-COLORED LIQUID WAS LEAKING FROM THE PASSER HANDLES. IT WAS UNCERTAIN WHICH PASSER(S) HAD CAUSED THE ISSUE. THE DEVICES IN QUESTION WERE NOT USED FOR THE PATIENT. THIS COMPLAINT INVOLVES 6 PARTS. THIS REPORT IS 4 OF 6 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7202062 ↗