NA 391.201Recalls & reported problems

Summary

The FDA's MAUDE database contains 118 adverse event reports that list this exact device (DI 10886982198204), received between Dec 12, 2016 and Feb 7, 2023 — classified as 5 injuries, 113 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (36 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 25 most recent of 118 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 7, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2023 THAT A CABLE GOT STUCK IN A TENSIONER DURING A CASE. THEY HAVE REMOVED THE CABLE FROM THE TENSIONER AFTER THE CASE. THE STERILE SERVICE TEAM MANAGED TO REMOVE IT. THERE WAS NO HARM DONE TO THE PATIENT AND THE OPERATION WAS ONLY DELAYED BY A FEW MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) CABLE TENSIONER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16311588 ↗
• MalfunctionJan 6, 2023Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT OPEN REDUCTION/INTERNAL FIXATION FOR THE THIGHBONE WITH THE PRODUCT IN QUESTION. DURING THE SURGERY, THE TWO REMAINING CABLES COULD NO LONGER BE TENSIONED. AN ALTERNATIVE PRODUCT WAS USED AND THE SURGERY WAS COMPLETED WITHOUT ANY PROBLEMS WITH IMPLANT FIXATION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN A 30-MINUTE DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE CABLE TENSIONER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16111248 ↗
• MalfunctionNov 1, 2022Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TENSIONERS NO LONGER TENSIONED ON ANY OF THE DEVICES. INTERNALLY THE DEVICES HAD ALL BROKEN AND WERE UNREPAIRABLE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE CABLE TENSIONER. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15710208 ↗
• MalfunctionNov 1, 2022Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TENSIONERS NO LONGER TENSIONED ON ANY OF THE DEVICES. INTERNALLY THE DEVICES HAD ALL BROKEN AND WERE UNREPAIRABLE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE CABLE TENSIONER. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15710202 ↗
• MalfunctionNov 1, 2022Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE TENSIONERS NO LONGER TENSIONED ON ANY OF THE DEVICES. INTERNALLY THE DEVICES HAD ALL BROKEN AND WERE UNREPAIRABLE. IT WAS REPORTED THAT THERE WAS NO PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE CABLE TENSIONER. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15710193 ↗
• MalfunctionAug 29, 2022Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2022, THE CABLE TENSIONER WAS FOUND IN THE TRAY WITH BROKEN CABLE STUCK IN THE CABLE TENSIONING DEVICE. THERE WAS NO REPORTED PATIENT INVOLVEMENT. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A CABLE TENSIONER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15311070 ↗
• MalfunctionJun 30, 2022Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT THE 391.201 NOT TIGHTENING CABLE. IT IS UNKNOWN WHEN THE ISSUE WAS OBSERVED. IT IS UNKNOWN IF THERE IS PATIENT INVOLVEMENT. IT IS UNKNOWN IF REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION OCCURRED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) CABLE TENSIONER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14881729 ↗
• MalfunctionMay 24, 2022Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN AUSTRALIA AS FOLLOWS: HOSPITAL COMPLAINT OF CABLE TENSIONER NOT FUNCTIONING CORRECTLY. RETURNING FOR EVALUATION. THIS CASE HAS BEEN REPORTED BY THE LOAN KIT TECHNICIAN DURING LOAN KIT INSPECTION. IT HAS BEEN FORWARDED TO DEPUY ENGINEERING FOR ASSESSMENT. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER. THIS COMPLAINT INVOLVES ONE DEVICE CABLE TENSIONER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14491041 ↗
• MalfunctionMay 16, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE CABLE DOESN¿T GO THOUGH THE TENSIONER. FIND WHILE DOING THE INVENTORY. NO PATIENT INVOLVEMENT. THIS COMPLAINT INVOLVES ONE DEVICE CABLE TENSIONER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14409927 ↗
• MalfunctionMay 12, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE USA AS FOLLOWS: IT WAS REPORTED THAT THE 391.201 CABLE IS BROKEN. IT IS UNKNOWN WHEN THE ISSUE WAS OBSERVED. IT IS UNKNOWN IF THERE IS PATIENT INVOLVEMENT. IT IS UNKNOWN IF REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION OCCURRED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) CABLE TENSIONER. THIS IS REPORT 1 OF 1 FOR COMPLAINT PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14375426 ↗
• MalfunctionMay 4, 2022Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: IT WAS REPORTED BY THE AFFILIATE IN COLOMBIA THAT DURING AN UNKNOWN SURGERY ON 4/6/2022, IT WAS OBSERVED THAT THE CERCLAGE CABLE DEVICE BURST. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14274161 ↗
• MalfunctionApr 14, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED STATES AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, ONE (1) CABLE TENSIONER WAS FOUND BROKEN INTO PIECES. IT IS UNKNOWN WHETHER IT IS FIELD EQUIPMENT OR HOSPITAL EQUIPMENT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT INVOLVES ONE (1) CABLE TENSIONER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14112932 ↗
• MalfunctionApr 6, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT RECEIVED A PHONE FROM OR WHERE SURGEON WAS ATTEMPTING TO TENSION A 1.7MM USING X1 391.201 LOT#P279304. HE WAS UNABLE TO PASS THE 1.7MM CABLE THROUGH THE TENSIONER DESPITE TENSIONER BEING ALL THE WAY OPEN. THERE IS SOME SORT OF BLOCKAGE IN THE TENSIONER. HE CALLED FOR ANOTHER SET AND PROCEDURE WAS COMPLETED SUCCESSFULLY WITH A 5 MINUTE DELAY. THERE WERE NO FRAGMENTS GENERATED. THERE WAS NO ADVERSE CONSEQUENCES. OTHER MEDICAL INTERVENTION REQUIRED WAS UNKNOWN. THIS COMPLAINT INVOLVES ONE(1) DEVICE CABLE TENSIONER. THIS IS REPORT 1 OF 1 FOR COMPLAINT PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14027197 ↗
• MalfunctionMar 25, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022 , WHEN THE SURGEON INSERTED A CABLE INTO THE TENSIONER, IT BECAME STUCK AND COULD NOT BE REMOVED. THE CABLE WAS CUT, AND ANOTHER TENSIONER RETRIEVED. SURGERY WAS SUCCESSFULLY COMPLETED WITH A DELAY OF FIVE MINUTES. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A CABLE TENSIONER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13908130 ↗
• MalfunctionMar 20, 2022Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT AS FOLLOWS: THE GOLDEN HANDLE CABLE TENSIONER DOES NOT RISE UP TO THE LIMIT OF THE TENSION LINE; ITS GIVES TENSION, BUT IT DOES NOT MARK. IN SURGERY THE CABLE DID HAVE GOOD TENSION. THERE WAS NO IMPACT TO THE PATIENT, THE SURGICAL TIME WAS NOT PROLONGED. THIS REPORT IS FOR A CABLE TENSIONER. THIS IS REPORT 1 OF 1 FOR PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13834942 ↗
• MalfunctionFeb 22, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION SURGERY FOR THE FEMORAL DIAPHYSEAL FRACTURE WITH CABLE TENSIONER IN QUESTION. DURING THE PROCEDURE, THE SURGEON PASSES THE CABLE THROUGH THE PLATE AND APPLIED TENSION WITH THE CABLE TENSIONER WHICH CAN BE APPLIED TENSION UP TO 50KG. HOWEVER, WHEN HE APPLIED 20 KG OF TENSION, THE KNOB OF THE TENSIONER DID NOT TURN AND MOVE FORWARD. WHEN THE SURGEON TRIED TO APPLY TENSION MANY TIMES, THERE WAS A FEELING THAT SOMETHING CLOGGING WAS GONE, AND HE WAS FINALLY ABLE TO PROCEED WITH THE CABLE TENSIONER. PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THIRTY(30) MINUTES OF SURGICAL DELAY. CONCOMITANT DEVICE REPORTED: UNK - CABLE/WIRE: (PART# UNKNOWN; LOT# UNKNOWN; QUALITY:1). THIS REPORT IS FOR ONE (1) CABLE TENSIONER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13581281 ↗
• MalfunctionFeb 3, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT IN STERILE PROCESSING ON AN UNKNOWN DATE, A CABLE TENSIONER HAD A CABLE STUCK IN IT. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR A CABLE TENSIONER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13441201 ↗
• MalfunctionDec 23, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE, THE CABLE TENSIONER DID GRASP THE CABLE AS EXPECTED. IT WAS NOTED THERE WAS NO SURGICAL DELAY OR MEDICAL INTERVENTION NEEDED. THIS REPORT IS FOR A CABLE TENSIONER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13077405 ↗
• MalfunctionDec 22, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN UNKNOWN PROCEDURE, THE CABLE BECAME STUCK IN THE CABLE TENSIONER. NO PATIENT CONSEQUENCE REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT WAS UNKNOWN IF THERE WAS SURGICAL DELAY. THIS REPORT IS FOR ONE (1) CABLE TENSIONER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13062112 ↗
• MalfunctionDec 17, 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 DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF SUB TROCHANTERIC, THE SURGEON TENSIONED THE CABLE WITHIN SPECIFICATIONS AND CRIMPED. WHEN SURGEON WENT TO RELEASE THE TENSION THE CABLE WOULD NOT COME OUT OF THE CABLE TENSIONER. THE CABLE WAS CUT AND ANOTHER SYSTEM WAS OPENED TO COMPLETE THE PROCEDURE. THE SURGERY WAS DELAYED FOR FIVE (5) MINUTES DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) CABLE TENSIONER. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13026251 ↗
• MalfunctionDec 13, 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 PATIENT UNDERWENT THE SURGERY WITH THE CABLE TENSIONER. FIRST, THE KNOB OF THE CABLE TENSIONER DID NOT TURN WHEN THE TENSION WAS BEING PUT ON. AFTER CUTTING THE CABLE AND WASHING THE CABLE TENSIONER WITH PHYSIOLOGICAL SALINE, THE KNOB COULD BE TURNED. NEXT, USING A NEW CABLE, THE TENSION WAS APPLIED TO THE CABLE TENSIONER. THEN LOCKED THE TENSION HOLDER AND THE TENSION WAS RELEASED BY REVERSE-ROTATING THE KNOB, BUT THE CABLE TENSIONER COULD NOT BE REMOVED FROM THE TENSION HOLDER. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN THIRTY (30) MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) CABLE TENSIONER. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12983202 ↗
• MalfunctionDec 9, 2021Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT AN UNKNOWN SURGICAL PROCEDURE FOR AN UNKNOWN REASON. THE CABLE TENSIONER WAS REPORTED AS BROKEN DURING THE PROCEDURE. NO OTHER INFORMATION IS KNOWN. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. IT WAS UNKNOWN IF THERE WAS SURGICAL DELAY. PATIENT'S OUTCOME WAS UNKNOWN. THIS REPORT IS FOR ONE (1) CABLE TENSIONER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12969725 ↗
• MalfunctionNov 30, 2021Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, DURING THE TIGHTENING OF THE CABLE THE CABLE SPLICES OPENED. THE SURGERY SUCCESSFULLY COMPLETED WITH ANOTHER CABLE TENSIONER. THERE WAS NO IMPACT TO THE SURGERY. THERE WAS NO IMPACT TO THE PATIENT. THIS REPORT INVOLVES ONE (1) CABLE TENSIONER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12891452 ↗
• MalfunctionNov 4, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT, DURING A PROCEDURE THE SURGEON WAS TENSIONING A 1.7 MM CABLE. ONCE COMPLETELY TENSIONED, PROVISIONALLY HELD THE GOLD TENSIONING KNOB TURNED COMPLETELY COUNTERCLOCKWISE AND THE CABLE TENSIONER WOULD NOT RELEASE THE CABLE. THE SURGEON WAS ABLE TO CRIMP AND CUT THE CABLE WITH THE CABLE TENSIONER STILL ATTACHED. LATER THE CABLE TENSIONER WAS INSPECTED AND INNER PIECES THAT HOLD THE CABLE TIGHT WOULD NOT OPEN. THE HOLDING WIRE WAS STUCK INSIDE THE CABLE TENSIONER. PROCEDURE WAS COMPLETED WITH LESS THAN ONE(1) MINUTE SURGICAL DELAY. THIS REPORT IS FOR ONE (1) CABLE TENSIONER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12754592 ↗
• MalfunctionSep 2, 2021Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY FOR THE FEMUR FRACTURE AROUND THE STEM WITH THE DISTAL FEMORAL PLATE AND THE CABLE SYSTEM. WHEN THE SURGEON FIXED THE PLATE WITH SCREWS AND WRAPPED THE CABLE AROUND THE BONE AND APPLIED THE TENSION, THE CABLE WAS CUT IN THE TENSIONER. THE SURGEON COULDN¿T REMOVE THE ENTANGLED CABLE FROM THE TENSIONER AND COULDN¿T USE IT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN THIRTY (30) MINUTES DELAY. PATIENT OUTCOME IS REPORTED AS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) CABLE TENSIONER THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12414693 ↗