NA 03.221.010Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10886982076724), received between Jan 27, 2017 and Jul 2, 2021 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Failure to Align” (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. 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 2, 2021Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT A SURGERY WHILE THE SURGEON WAS USING THE CERCLAGE PASSER IN QUESTION, THE SHAFT GOT BENT. SURGEON WAS PROPERLY USING THE CERCLAGE PASSER ACCORDING TO THE SURGICAL TECHNIQUE. THE HOSPITAL PURCHASED THIS CERCLAGE PASSER IN (B)(6) 2020 AND THIS EVENT OCCURRED IN THE FOURTH USE AFTER PURCHASE. CONCOMITANT DEVICE REPORTED: UNKNOWN TROCAR (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1) THIS REPORT IS FOR ONE (1) CERCLAGE PASSER, DIVIDABLE FORCEPS, SMALL. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12108585 ↗
• MalfunctionMay 11, 2021Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CERCLAGE PASSER¿S BITE WAS FOUND TO BE INACCURATE. THERE WERE SCRATCHES ON THE OUTER SURFACE OF THE INSTRUMENT. THIS REPORT INVOLVES ONE (1) CERCLAGE PASSER, DIVIDABLE FORCEPS, SMALL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11806167 ↗
• MalfunctionDec 29, 2020Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CERCLAGE PASSER WAS NOT WORKING DUE TO A MISMATCH IN THE TWO ARMS OF THE DEVICE. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE CERCLAGE PASSER, DIVIDABLE FORCEPS, SMALL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11089617 ↗
• MalfunctionDec 28, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 DURING AN UNKNOWN PROCEDURE, THE CERCLAGE PASSER DID NOT CONTACT CORRECTLY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A CONVENTIONAL ONE-WAY PASSER. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. THERE IS NO FURTHER INFORMATION AVAILABLE. UNKNOWN CERCLAGE CABLE (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR ONE (1) CERCLAGE PASSER, DIVIDABLE FORCEPS, SMALL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11077169 ↗
• MalfunctionDec 14, 2020Corroded; Corroded

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WAS RUST FOUND ON THE CERCLAGE PASSER. THERE WAS NO PATIENT INVOLVEMENT. THE ISSUE WAS DISCOVERED DURING CLEANING. THIS REPORT IS FOR ONE (1) CERCLAGE PASSER, DIVIDABLE FORCEPS, SMALL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11003065 ↗
• MalfunctionJul 16, 2020Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON JUNE 29, 2020 THAT ON AN UNKNOWN DATE THE TWO TIPS OF THE CERCLAGE PASSER DIVIDABLE FORCEPS WERE BENT AND COULD NOT FIT TOGETHER. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH ANOTHER INSTRUMENT. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. THERE WAS NO CONSEQUENCE TO PATIENT. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) CERCLAGE PASSER, DIVIDABLE FORCEPS, SMALL. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10283209 ↗
• MalfunctionMay 16, 2019Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PROPER CLOSING AND LOCKING OF CERCLAGE PASSER WAS IMPOSSIBLE IN A CLOSED POSITION. IT WAS UNKNOWN IF THERE WAS PATIENT OR PROCEDURE INVOLVEMENT. THIS REPORT IS FOR ONE (1) CERCLAGE PASSER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8616748 ↗
• MalfunctionMar 29, 2019Failure to Align

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: BQ RECEIVED A DAMAGED DEVICE 03.221.010, LOT 9627873 FROM THE CUSTOMER. ISSUE REPORTED END/TIPS NOT ALIGNED THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8467087 ↗
• MalfunctionFeb 26, 2019Dull, Blunt; Device Difficult to Maintain; Dull, Blunt; Device Difficult to Maintain

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, A CERCLAGE WIRE PASSER WAS NOT WORKING PROPERLY. WIRE PASSER LOCK WAS NOT LOOSE AND HAPPENED IN JUST THIRD TIME USE OF THE DEVICE. THE WIRE WAS NOT GETTING PASSED EASILY AND GETTING STUCK AT THE JUNCTION OF TWO ARMS DURING AN UNKNOWN SURGERY. THERE WAS NO SURGICAL DELAY REPORTED. SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT STATUS WAS STABLE. THIS REPORT IS FOR ONE (1) CERCLAGE PASSER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8370450 ↗
• MalfunctionSep 24, 2018Material Twisted/Bent; Material Twisted/Bent

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, IT WAS NOTICED POST-OPERATIVELY BY THE HOSPITAL STAFF THAT THE TIPS OF THE CERCLAGE PASSER WERE NOT COMPLETELY ALIGNED TOGETHER. THERE WAS NO PROCEDURE AND PATIENT INVOLVEMENT REPORTED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7903350 ↗
• MalfunctionApr 9, 2018Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE CERCLAGE PASSER (03.221.010) IN QUESTION WAS USED IN UNKNOWN SURGERY ON UNKNOWN DATE. WHEN THE CERCLAGE PASSER WAS USED, TIPS OF BOTH TUBES DID NOT COMPLETELY ENGAGE EACH OTHER. WITH A REPLACEMENT, THE SURGERY WAS COMPLETED WITHOUT A DELAY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. COMPLAINT INVOLVES ONE PART. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7409923 ↗
• MalfunctionMar 8, 2018Failure to Align; Failure to Align

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED, THAT THE REPORTED DEVICE WAS USED IN AN UNKNOWN SURGERY ON (B)(6) 2018. IN SPITE OF AN INITIAL USE SINCE THE HOSPITAL PURCHASED IN FEB. 2017, TIPS OF CERCLAGE PASSER¿S TUBES IN QUESTION DID NOT COMPLETELY ENGAGE EACH OTHER. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY AND ANY OTHER PROBLEMS. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7323041 ↗
• MalfunctionJan 17, 2018Failure to Align; Failure to Align

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A MISALIGNMENT OCCURRED WHEN COMBINING TWO PASSERS. NO PATIENT WAS INVOLVED. CONCOMITANT DEVICES REPORTED: CERCLAGE TUNNELING DEVICE (PART # 03.221.002, LOT # 8080042, QUANTITY 1), CERCLAGE TUNNELING DEVICE LARGE (PART # 03.221.004, LOT # 8755104, QUANTITY 1), TROCAR FOR CERCLAGE PASSER (PART # 03.221.003, LOT # 8737916, QUANTITY 1), TROCAR FOR CERCLAGE PASSER (PART # 03.221.003, LOT # 8771249, QUANTITY 1). THIS REPORT IS FOR ONE (1) CERCLAGE PASSER, DIVIDABLE FORCEPS, SMALL. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available

  MAUDE report 7201607 ↗
• MalfunctionJul 19, 2017Failure to Align; Failure to Align

  UPDATE: CONCOMITANT QUANTITY ADDED 2 TROCARS FOR CERCLAGE PASSERS IDENTIFIED DURING INVESTIGATION. TWO, CONCOMITANT 03_221_003 TROCARS FOR CERCLAGE PASSER WERE RETURNED WITH THE PASSER. FUNCTIONAL TESTING INDICATED THE TROCARS FOR CERCLAGE PASSER PASSED THROUGH THE PASSER, CANNULA FREE AND NON BINDING.

  Patient problems: No Patient Involvement

  MAUDE report 6724872 ↗
• MalfunctionApr 11, 2017Bent; Bent

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOW: IT WAS REPORTED THAT THE PATIENT UNDERWENT SURGERY FOR FEMUR TROCHANTERIC FRACTURE ON (B)(6) 2017. AFTER THE SURGEON PUSHED THE CABLE PASSING TUBE THROUGH THE TUBE OF CERCLAGE PASSER, HE TRIED TO PASS A CABLE 1.7MM. HOWEVER, IT DIDN¿T PASS THROUGH SO HE EXTRACTED IT. THEN HE FOUND OUT THAT THE CABLE PASSING TUBE WAS BENT. WHEN THE SURGEON USED ANOTHER CABLE PASSING TUBE, THE CABLE DIDN¿T PASS AS WELL. EVENTUALLY HE MANAGED TO PASS THE CABLE BUT WHEN HE REMOVED THE CABLE PASSING TUBE (THE SECOND ONE), IT WAS BENT AS WELL. ADDITIONALLY, THE CERCLAGE PASSER TIPS WERE SLIGHTLY DEFORMED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE SURGERY WAS EXTENDED FOR THIRTY (30) MINUTES. PATIENT OUTCOME WAS NOT REPORTED. CONCOMITANT DEVICE: CABLE (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY 1) . THIS REPORT IS FOR ONE (1) CERCLAGE PASSER, DIVIDABLE FORCEPS, SMALL. THIS IS REPORT 1 OF 2 FOR COM-(B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6482747 ↗
• MalfunctionMar 28, 2017Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES EUROPE REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE TIP OF THE CERCLAGE PASSER IS DEFORMED. THERE WAS NO REPORTED PATIENT INVOLVEMENT. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6440223 ↗
• MalfunctionJan 27, 2017Break; Material Fragmentation; Break; Material Fragmentation

  DEVICE REPORT SYNTHES EUROPE REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ON AN UNKNOWN DATE, THE NUT COMPONENT OF THE CERCLAGE PASSER BROKE WHILE PASSING THE STAINLESS STEEL WIRE IN THE FEMUR. THE BROKEN FRAGMENTS WERE EASILY REMOVED FROM THE PATIENT. THE PROCEDURAL STEP WAS COMPLETED BY PASSING THE WIRE BY HAND. THE SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT DELAY AND WITHOUT PATIENT HARM. THIS IS REPORT 1 OF 1 FOR COM-(B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6282535 ↗