NA 03.221.011Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10886982076731), received between Dec 20, 2016 and Sep 23, 2025 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (5 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2025Break; Break

  IT WAS REPORTED THAT THE WELDED PART OF THE INSTRUMENT HAS COME OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23121127 ↗
• MalfunctionFeb 12, 2025Break; Break

  IT WAS REPORTED THAT THERE WAS A PIECE OF THE WELDING MISSING WHICH LEFT A GAP. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21363195 ↗
• MalfunctionJan 27, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2021, DURING A PROCEDURE THE INSTRUMENT DID NOT ALLOW THE CERCLAGE CABLE TO PASS THROUGH PROPERLY. THERE WAS NO SURGICAL DELAY. THERE WERE NO FRAGMENTS GENERATED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT INVOLVES ONE (1) CERCLAGE PASSER, DIVIDABLE FORCEPS, LARGE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13367581 ↗
• MalfunctionSep 2, 2021Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE INSTRUMENT WOULD NOT LINE UP AND THERE WAS DIFFICULTY GETTING THE WIRE TO PASS THROUGH. THIS REPORT INVOLVES ONE (1) CERCLAGE PASSER, DIVIDABLE FORCEPS, LARGE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12414494 ↗
• MalfunctionDec 21, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN INDIA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6), 2020, DURING AN UNKNOWN SURGERY THAT THE WIRE COULD NOT PASS THROUGH THE WIRE PASSER DUE TO THE TWO ARMS OF THE CERCLAGE PASSER, DIVIDABLE FORCEPS. ANOTHER INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE. CONCOMITANT DEVICES REPORTED: WIRE/CABLE CERCLAGE (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) CERCLAGE PASSER, DIVIDABLE FORCEPS, LARGE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11050753 ↗
• MalfunctionSep 30, 2020Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2020, THE CERCLAGE PASSER WAS NOT WORKING. THE TWO ARMS OF THE INSTRUMENT WERE NOT IN ALIGNMENT WITH EACH OTHER. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO SURGICAL DELAY. THE PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) CERCLAGE PASSER, DIVIDABLE FORCEPS, LARGE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10608444 ↗
• MalfunctionSep 25, 2019Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TIP OF THE DEVICE WAS DISTORTED AND EACH TIP DID NOT MESH. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) CERCLAGE PASSER, DIVIDABLE FORCEPS, LARGE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9119487 ↗
• MalfunctionJun 12, 2019Material Deformation; Material Deformation

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT DURING MAINTENANCE ON MARCH 25, 2019, IT WAS DISCOVERED THAT TWO PARTS OF THE CERCLAGE PASSER WOULD NOT GO TOGETHER. THERE WAS NO PATIENT INVOLVEMENT. UPON MANUFACTURER RECEIPT AND INVESTIGATION, IT WAS DETERMINED THAT THE DEVICE WAS DEFORMED/BENT. THIS REPORT IS FOR A CERCLAGE PASSER, DIVIDABLE FORCEPS, LARGE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8691844 ↗
• MalfunctionOct 1, 2018Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, THE TIPS OF THE CERCLAGE PASSER FORCEPS DID NOT ALIGN WHEN THEY WERE PLACED IN THE CLOSED POSITION. ALSO, THIS OCCURRED WITH THE FIRST TIME USE OF THE FORCEPS. PATIENT AND PROCEDURE INVOLVEMENT ARE UNKNOWN. THIS REPORT IS FOR ONE (1) CERCLAGE PASSER, DIVIDABLE FORCEPS, LARGE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7923520 ↗
• MalfunctionAug 31, 2018Material Deformation; Material Deformation

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2018, THE CERCLAGE PASSER WAS FOUND TO BE DEFORMED. THE INSTRUMENT CANNOT CLOSE PROPERLY. SURGICAL OUTCOME AND PATIENT STATUS IS UNKNOWN. THIS REPORT IS FOR A CERCLAGE PASSER, DIVIDABLE FORCEPS, LARGE. (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7837141 ↗
• MalfunctionMay 3, 2018Break; Break

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT PRE-OPERATIVELY THE CERCLAGE PASSER BROKE. NO PATIENT INVOLVEMENT. UPON RECEIPT OF THE COMPLAINED INSTRUMENT AT MANUFACTURER¿S ANALYSIS SITE, IT COULD BE CONFIRMED THAT THE TIP OF THE CERCLAGE PASSER IS NOT BROKEN OFF AS PREVIOUSLY MENTIONED IN THE DEVICE REPORT BUT ONE OF THE TUBES IS DEFORMED AND PRESENTS SCRATCHES AND DENTS; HENCE THE INSTRUMENT DOES NOT CLOSE PROPERLY. (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 7485191 ↗
• 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, LARGE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available

  MAUDE report 7201669 ↗
• MalfunctionNov 28, 2017Failure to Align; Failure to Align

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT WHILE INSTALLING NEW CERCLAGE PASSER, DIVIDABLE FORCEPS, LARGE IT WAS FOUND THAT TWO ENDS OF CERCLAGE PASSER ARE NOT MATCHING EACH OTHER. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THIS REPORT IS FOR ONE (1) CERCLAGE PASSER, DIVIDABLE FORCEPS, LARGE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Code Available

  MAUDE report 7065018 ↗
• MalfunctionAug 7, 2017Failure to Align; Failure to Align

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT TWO PIECES INSTRUMENT CERCLAGE PASSER, DIVIDABLE FORCEPS CANNOT BE ENGAGED BECAUSE OF DEFORMITY. THIS WAS DETECTED BEFORE USE ON PATIENT. NO SURGERY AND PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) CERCLAGE PASSER, DIVIDABLE FORCEPS, LARGE THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4)

  Patient problems: No Patient Involvement

  MAUDE report 6770299 ↗
• MalfunctionJul 31, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY THE WIRE PASSERS DO NOT MEET AT THE TIP. THE PASSING TUBE CANNOT BE PASSED THROUGH THEM. TO RESOLVE THE PROBLEM THEY USED A STANDARD WIRE PASSER. THE SURGERY WAS PROLONGED ABOUT 10 MINUTES. THERE WAS NO PATIENT HARM AND THE SURGERY WAS SUCCESSFULLY COMPLETED. CONCOMITANT REPORTED PART: 1X UNKNOWN PASSING TUBE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6755384 ↗
• 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, LARGE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6482732 ↗
• MalfunctionFeb 22, 2017Failure to Align; Failure to Align

  IT WAS REPORTED THAT THE CLAMP OF A CERCLAGE PASSER IS NOT LINING UP PROPERLY. THE TWO POINTS AT THE TOP WHERE THE CABLE IS SUPPOSED TO PASS THROUGH IS NOT LINING UP. THE DEVICE MAY BE BENT. THIS WAS IDENTIFIED IN STERILE PROCESSING. NO PROCEDURE OR PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6348695 ↗
• MalfunctionJan 24, 2017Break; Break

  DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY ONE CERCLAGE PASSER GOT BEND AND THE BOLT OF ANOTHER CERCLAGE PASSER BROKE. NO INFORMATION AVAILABLE ABOUT PATIENT CONDITION, OUTCOME AND PROLONGATION. THIS COMPLAINT IS ONLY ABOUT ONE PART CERCLAGE PASSER. THE NUT WAS BROKEN BUT AS THE NUT WAS ATTACHED IN OUTER PORTION SO BROKEN FRAGMENT HAS NO CONTACT WITH PATIENT. NO DELAY TO SURGERY TIME. NO PATIENT HARM. THIS REPORT IS 1 OF 1 FOR COM-(B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6274204 ↗
• MalfunctionDec 20, 2016Failure To Adhere Or Bond; Failure To Adhere Or Bond

  DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT BOTH SLEEVE ENDS OF A CERCLAGE PASSER DO NOT FIT OR CLOSE PROPERLY. IT IS UNKNOWN WHEN THE ISSUE OCCURRED OR WHEN IT WAS DETECTED, BUT THERE WAS NO PATIENT INVOLVED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 6189052 ↗