NA 03.221.015Recalls & reported problems

Summary

The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 10886982076748), received between Mar 15, 2017 and Jan 13, 2023 — classified as 1 injury, 66 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (39 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 25 most recent of 67 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CABLE TENSIONER ONE-H+OPERABLE HAD UNKNOWN MALFUNCTIONS. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE CABLE TENSIONER WITH PISTOL GRIP. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16157363 ↗
• MalfunctionDec 30, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE 03.221.015 X2 NOT GRASPING THE CABLE. THE CABLE SLIPS WHEN YOU GO TO TENSION IT. 391.884 WILL NOT HOLD THE PIECE THAT GOES ON IT. THE ISSUE WAS OBSERVED DURING ALL OF THESE WERE NOTED IN PRE-SURGERY FOR THE SAME PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THERE WAS NO FURTHER INFORMATION REGARDING THE ISSUE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE CABLE TENSIONER WITH PISTOL GRIP. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16080635 ↗
• MalfunctionDec 30, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE 03.221.015 X2 NOT GRASPING THE CABLE. THE CABLE SLIPS WHEN YOU GO TO TENSION IT. 391.884 WILL NOT HOLD THE PIECE THAT GOES ON IT. THE ISSUE WAS OBSERVED DURING ALL OF THESE WERE NOTED IN PRE-SURGERY FOR THE SAME PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. IT WAS REPORTED THAT THERE WAS NO FURTHER INFORMATION REGARDING THE ISSUE. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE CABLE TENSIONER WITH PISTOL GRIP. THIS IS REPORT 1 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16080634 ↗
• MalfunctionNov 28, 2022Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE DEVICES HAD UNKNOWN MALFUNCTIONS. IT IS UNKNOWN IF THERE IS PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) CABLE TENSIONER WITH PISTOL GRIP. THIS IS REPORT 1 OF (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15868539 ↗
• MalfunctionNov 21, 2022Break; Material Deformation; Break; Material Deformation

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE IN 2022, THE CABLE TENSIONER IN QUESTION WAS FOUND TO BE BROKEN AND WORN. NO PATIENT INTERACTION WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED. THIS REPORT IS FOR A CABLE TENSIONER WITH PISTOL GRIP. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15833592 ↗
• MalfunctionNov 10, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, THE PROVISIONAL TENSIONING DEVICE WOULD NOT STAY ATTACHED TO THE ONE-HANDED OPERABLE CABLE TENSIONER. IT KEPT FALLING OFF. SURGERY WAS COMPLETED WITH A NINETY MINUTE DELAY. THIS REPORT IS FOR A CABLE TENSIONER WITH PISTOL GRIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15775394 ↗
• MalfunctionOct 31, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6), 2022, THE ITEMS SLIPPED WHILE TRYING TO TENSION. NO SURGICAL PROCEDURE WAS INVOLVED WITH THIS EVENT, THEREFORE THERE WAS NO PATIENT CONSEQUENCE.. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE CABLE TENSIONER WITH PISTOL GRIP. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15699181 ↗
• MalfunctionOct 19, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, THE SURGEON WENT TO USE THE ONE-HANDED CABLE TENSIONER AND IT WAS NOT TENSIONING THE 1.7MM CABLE PROPERLY. THE SURGEON COULD HEAR THE CLICKS AS HE PULLED THE TRIGGER, BUT THE TENSIONER DID NOT ADVANCE/TIGHTEN CABLES. NO FURTHER DETAILS ARE AVAILABLE. THIS REPORT INVOLVES ONE CABLE TENSIONER WITH PISTOL GRIP. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15633077 ↗
• MalfunctionOct 6, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2022 PISTOL GRIP TENSIONER WAS FAILING DURING FINAL TIGHTENING ATTEMPTS. THERE WAS NO SURGICAL DELAY AND PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCES. THIS REPORT IS FOR ONE CABLE TENSIONER WITH PISTOL GRIP. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15550231 ↗
• MalfunctionAug 19, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED A TENSIONER BROKE INTRAOPERATIVELY JULY 20, 2022. NEW SET OPENED, BUT SECOND TENSIONER ALSO BROKE. HAD TO USE DIFFERENT TENSIONER. SURGICAL DELAY OF 5 MINUTES WAS NOTED. THIS REPORT INVOLVES ONE (1) CABLE TENSIONER WITH PISTOL GRIP. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15257332 ↗
• MalfunctionAug 17, 2022Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2022, THAT THE TENSIONER BROKE. NEW SET WAS OPENED, BUT SECOND TENSIONER ALSO BROKE. HAD TO USE DIFFERENT TENSIONER. THE SURGERY WAS DELAY FOR 5 MINUTES. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR ONE (1) CABLE TENSIONER ONE-H+OPERABLE THIS IS REPORT 1 OF 1 FOR COMPLAINT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15245005 ↗
• MalfunctionAug 10, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE IN 2022, A CABLE TENSIONER DEVICE WON¿T TENSION. THERE WAS A TWO (2) MINUTES OF SURGICAL DELAY TO PUT DEVICE BACK TOGETHER. NO OTHER MEDICAL INTERVENTION REQUIRED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) CABLE TENSIONER WITH PISTOL GRIP. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15203015 ↗
• MalfunctionAug 4, 2022Break; Break

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CABLE TENSIONER WAS NOTICED TO BE BROKEN. THIS WAS DISCOVERED DURING CLEANING. THERE WAS NO DELAY TO SURGERY TIME. THIS REPORT IS FOR A CABLE TENSIONER WITH PISTOL GRIP. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15168347 ↗
• MalfunctionAug 4, 2022Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2022, THE CABLE TENSIONER WAS NOT TENSIONING AND STRIPPING THE CABLES. THE SPARE TENSIONER WAS OPENED TO COMPLETE THE PROCEDURE. THERE WAS A TEN (10) MINUTES OF SURGICAL DELAY. THERE WAS NO PATIENT HARM. THIS REPORT IS FOR ONE (1) CABLE TENSIONER WITH PISTOL GRIP THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15167953 ↗
• MalfunctionJul 22, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING DEVICE INSPECTION IT WAS IDENTIFIED THAT THE CABLE TENSIONER RELEASES THE CABLE AFTER TIGHTENING. IT WORKS INITIALLY BUT THEN THE CABLE SLIPS. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) CABLE TENSIONER WITH PISTOL GRIP. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15086846 ↗
• MalfunctionApr 18, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP IN UNITED KINGDOM THAT DURING A PERIPROSTHETIC FRACTURE FIXATION PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE SURGEON WAS NOT ABLE TO RELEASE THE GUN DEVICE FROM THE CABLE DEVICE AFTER TENSIONING. ACCORDING TO THE REPORT, IT TOOK THE SURGEON A FEW TRIES TO BE ABLE TO RELEASE IT. AT THE NEXT CABLE INSERTION, HE WAS NOT ABLE TO PASS THE NEW WIRE THROUGH THE DEVICE. ANOTHER LIKE DEVICES WERE USED TO COMPLETE THE PROCEDURE WITH AN UNSPECIFIED DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) CABLE TENSIONER WITH PISTOL GRIP DEVICE. THIS COMPLAIN INVOLVES TWO(2) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14137948 ↗
• MalfunctionMar 10, 2022Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN USA AS FOLLOWS: IT WAS REPORTED THAT ON FEBRUARY 10, 2022, AN UNKNOWN SURGICAL PROCEDURE WAS PERFORMED FOR UNKNOWN REASON. THE TENSIONER DOES NOT HOLD TENSION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT SURGICAL DELAY. THERE WAS NO PATIENT CONSEQUENCE REPORTED. THIS COMPLAINT INVOLVES ONE(1) DEVICE CABLE TENSIONER WITH PISTOL GRIP. THIS IS REPORT 1 OF 1 FOR COMPLAINT PC-(B)(4). .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13720398 ↗
• MalfunctionFeb 4, 2022Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A HIP REVISION SURGERY, DUE TO A PERIPROSTETIC FRACTURE, THE CABLE TENSIONER STOPPED WORKING. THE TOOL COULD NOT HOLD THE TENSION AND WHEN THE TENSION ARM WAS RESET, IT WOULD NOT RETRACT ON ITS OWN. THERE WAS A SURGICAL DELAY OF TEN (10) MINUTES. A COMPETITOR¿S DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE SURGERY WAS SUCCESSFULLY COMPLETED. THIS REPORT INVOLVES ONE (1) CABLE TENSIONER WITH PISTOL GRIP. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13451174 ↗
• MalfunctionJan 10, 2022Connection Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, BOTH CABLE TENSIONER WITH PISTOL GRIP WAS UNABLE TO HOLD THE CABLE WITHIN ITS CONSTRUCT ONCE FULLY TENSIONED. CABLES WOULD CONTINUOUSLY SLIDE THROUGH THE TENSIONER PREVENTING THE FINAL TENSION FROM BEING REACHED. IT WAS UNKNOWN WHEN THE ISSUE WAS DISCOVERED. PATIENT AND PROCEDURE INVOLVEMENT ARE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN CABLES (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES.

  Patient problems: Insufficient Information

  MAUDE report 13214159 ↗
• MalfunctionJan 10, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, BOTH CABLE TENSIONER WITH PISTOL GRIP WAS UNABLE TO HOLD THE CABLE WITHIN ITS CONSTRUCT ONCE FULLY TENSIONED. CABLES WOULD CONTINUOUSLY SLIDE THROUGH THE TENSIONER PREVENTING THE FINAL TENSION FROM BEING REACHED. IT WAS UNKNOWN WHEN THE ISSUE WAS DISCOVERED. PATIENT AND PROCEDURE INVOLVEMENT ARE UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN CABLES (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR (1) CABLE TENSIONER WITH PISTOL GRIP. THIS REPORT IS 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13214147 ↗
• MalfunctionJan 5, 2022Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE CABLE TENSIONER DID NOT HAVE THE STRENGTH BEFORE SNAPPING OFF AND NO LONGER TIGHTENED THE CERCLAGE. NO PATIENT INVOLVEMENT REPORTED. THIS REPORT IS FOR ONE (1) CABLE TENSIONER WITH PISTOL GRIP. THIS IS REPORT 1 OF 1 FOR (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13168128 ↗
• MalfunctionNov 25, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE SALES CONSULTANT FOUND THE CABLE TENSIONER WOULD NOT TENSION WHILE DOING AN IN SERVICE FOR STAFF. THERE WAS NO PATIENT OR SURGICAL INVOLVEMENT. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) CABLE TENSIONER WITH PISTOL GRIP. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12874031 ↗
• MalfunctionAug 23, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING A PROCEDURE, THE TENSIONER PORTION OF THE CABLE SYSTEM WOULD NOT ALLOW IT TO TENSION PROPERLY. THERE WAS AN UNKNOWN SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME IS UNKNOWN. 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 12354315 ↗
• MalfunctionAug 13, 2021Break

  IT WAS REPORTED THAT, THE CABLE TENSIONER WITH PISTOL GRIP WAS BROKEN. THE ISSUE WAS DISCOVERED IN THE FIELD INVENTORY. NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) CABLE TENSIONER WITH PISTOL GRIP. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12321492 ↗
• MalfunctionAug 10, 2021Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT DURING A PROCEDURE ON (B)(6) 2021, A CABLE GUN TENSIONER WOULD NOT TENSION. ANOTHER TENSIONER WAS USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A CABLE TENSIONER WITH PISTOL GRIP. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12300903 ↗