NA 03.221.003Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10886982076663), received between Feb 24, 2017 and Jan 27, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 27, 2025Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2025, THE PATIENT UNDERWENT AN UNKNOWN SURGERY WITH THE PRODUCT IN QUESTION. WHEN THE SALES REP WAS EXPLAINING THE INSTRUMENTATION AND PUT THE TROCAR IN QUESTION THROUGH THE CERCLAGE PASSER, THE TROCAR BROKE OFF AT THE BASE. THE DAMAGE TO THE INSTRUMENT HAS OCCURRED OUTSIDE THE PATIENT'S BODY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21246170 ↗
• MalfunctionAug 30, 2024Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE ITEM WAS RECEIVED BROKEN AT THE DISTRIBUTION CENTER. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE TROCAR FOR CERCLAGE PASSER THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20106404 ↗
• MalfunctionApr 16, 2024Break; Break

  IT WAS REPORTED THAT ON UNKNOWN DATE, THE PATIENT UNDERWENT AN OSTEOSYNTHESIS FOR A FEMORAL FRACTURE. DURING THE SURGERY, THE SURGEON SAID THE TIP OF THE PRODUCT WAS CUT OFF. THE SURGEON JUDGED THAT IT WAS DUE TO THE PRODUCT'S AGE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. THE PATIENT OUTCOME WAS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE TROCAR F/CERCL-PASSER NOS. 03.221.010+03 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19115668 ↗
• MalfunctionApr 8, 2024Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2024, THE DEVICE BROKE DURING SURGERY. THERE WAS NO CASE DELAY AND NO PATIENT CONSEQUENCES/OUTCOME. THIS REPORT IS FOR ONE (1) TROCAR FOR CERCLAGE PASSER THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19068244 ↗
• MalfunctionApr 3, 2024Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY. DURING THE SURGERY, THE TROCAR WAS USED IN THE PASSER, BUT THE TROCAR BROKE OFF WHEN THE TROCAR WAS TRIED TO BE PULLED OUT OF THE PASSER. IT WAS CONFIRMED BY X-RAY THAT NO BROKEN PIECES WERE LEFT IN THE PATIENT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) TROCAR FOR CERCLAGE PASSER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19037993 ↗
• MalfunctionMar 4, 2024Break; Break

  DEVICE REPORT FROM JAPAN REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2024, THE TROCAR IN QUESTION WAS BROKEN. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TROCAR FOR CERCLAGE PASSER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18825824 ↗
• MalfunctionDec 14, 2023Break; Break

  DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TROCAR IN QUESTION HAD BROKEN. THERE WAS NO REPORTED PATIENT OR PROCEDURE INTERACTION. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A TROCAR FOR CERCLAGE PASSER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 18329146 ↗
• MalfunctionDec 1, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2023, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. WHEN THE PACKAGE WAS OPENED, IT WAS CONFIRMED THAT THE CERCLAGE PASSER IN QUESTION WAS BROKEN. ACCORDING TO THE AGENT, THE DEVICE WAS LYING AROUND WHEN THE PACKAGE WAS OPENED. THE DEVICE WAS NOT USED FOR SURGERY. PATIENT STATUS/ OUTCOME: STABLE NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) TROCAR F/CERCL-PASSER NOS. 03.221.010+03 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18248447 ↗
• MalfunctionOct 18, 2023Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT THE BALL-SHAPED JOINT THAT WAS SUPPOSED TO FUNCTION AS A STOPPER HAS COME OFF AND IS NO LONGER FUNCTIONAL. THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEMS WITH USING ALTERNATIVE TECHNIQUES. THE PRODUCT HAS NOT BEEN USED AFTER PURCHASE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) TROCAR F/CERCL-PASSER NOS. 03.221.010+03 THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17958673 ↗
• MalfunctionNov 11, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TROCAR FOR THE CERCLAGE PASSER COULD NOT BE INSERTED COMPLETELY. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) TROCAR FOR CERCLAGE PASSER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12798235 ↗
• MalfunctionFeb 5, 2020Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE TROCAR FOR CERCLAGE PASSER WAS FOUND BENT. THERE WAS NO SURGERY OR PATIENT INVOLVEMENT. THIS IS REPORT 01 OF 01 OF (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9670512 ↗
• MalfunctionFeb 24, 2017Break; Break

  SYNTHES EUROPE REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE CHARGE NURSE WAS SHOWING STAFF MEMBERS HOW THE INSTRUMENT WORKED WHEN THE SHAFT OF THE TROCAR BECAME SEPARATED FROM THE HANDLE OF THE INSTRUMENT. IT IS A NEW INSTRUMENT AND HAD NOT YET BEEN STERILIZED FOR USE. NO ADVERSE EVENT. NO PATIENT INVOLVEMENT. THIS IS REPORT NUMBER 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6358178 ↗