NA 03.221.017Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10886982076779), received between Aug 24, 2018 and Jan 13, 2023 — classified as 34 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (23 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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2023Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: IT WAS REPORTED ON AN UNKNOWN DATE THAT THE ITEMS WERE RETURNED TO THE TRUST FROM THEIR OUTSOURCED STERILIZATION HUB, AND WERE LABELLED AS DAMAGED. THE ITEM DOES NOT ALLOW THE CABLE TO PASS THROUGH THE CANNULATION, IT DOES NOT APPEAR TO BE FULLY BLOCKED, BUT THE LOCKING MECHANISM WILL NOT ALLOW ANYTHING THROUGH. THE ITEM HA, BEEN DAMAGED FOR SOME TIME, BUT ONLY REPORTED WHEN THE ABOVE ITEM HAS FLAGGED. THE TENSION RELEASE PADDLE DOES NOT WORK AND SO THE GUN IS UNABLE TO FUNCTION. AS THE ITEMS WERE RETURNED FROM THE HUB AND FLAGGED AT THIS TIME, IT IS NOT KNOWN WHAT CASE, OR SURGEON WERE IN CHARGE OF THE TIME OF THE PROBLEM AND NO OTHER INFORMATION IN AVAILABLE. THIS REPORT IS FOR ONE (1) CABLE LOCK Ø1.7 F/CABLE TENSIONER ONE-H+. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16161810 ↗
• MalfunctionDec 6, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CANADA AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, DUE TO WEAR AND TEAR AND OVERUSE, THE 1.7MM CABLE LOCK FOR THE PISTOL GRIP TENSIONER WASN'T PROPERLY LOCKING THE CABLE IN PLACE AND GETTING JAMMED INSIDE THE CABLE LOCK. THERE WAS NO PATIENT INVOLVEMENT AND NO DELAY IN SURGERY. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE Ø1.7MM CABLE LOCK FOR PISTOL GRIP CABLE TENSIONER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15925220 ↗
• MalfunctionNov 16, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, DURING AN OPEN REDUCTION INTERNAL FIXATION OF A PERIPROSTHETIC FEMUR FRACTURE, THE SURGEON WAS USING THE SYNTHES ORTHOPEDIC CABLE SYSTEM WITH THE PISTOL GRIP TENSIONING GUN WHEN HE EXPERIENCED A MALFUNCTIONING 1.7MM CABLE LOCK. THE LEVER ON THE LOCK WOULD FREEZE HALFWAY AND WOULD NOT LOCK THE CABLE DOWN. A SECOND SET WAS OPENED AND THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT DELAY. SURGEON MENTIONED THAT THIS HAPPENED BEFORE AND REQUESTED THAT THE LOCK BE REMOVED FROM THE SET AND INSPECTED. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR A Ø1.7MM CABLE LOCK FOR PISTOL GRIP CABLE TENSIONER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15804937 ↗
• MalfunctionNov 4, 2022Break; Break

  DEVICE REPORT FROM THE UNITED KINGDOM REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE LOCK ON THE CABLE SYSTEM BROKE. PROCEDURE WAS COMPLETED WITH NO DELAY. THERE WAS NO PATIENT HARM. THIS REPORT IS FOR A Ø1.7MM CABLE LOCK FOR PISTOL GRIP CABLE TENSIONER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15734134 ↗
• 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 Ø1.7MM CABLE LOCK FOR PISTOL GRIP CABLE TENSIONER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15698787 ↗
• MalfunctionOct 31, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6)2022, THE 1.7 CABLE LOCK WAS BROKEN FROM A DS FIELD INVENTORY LCP PERIPROSTHETIC SYSTEM AND WILL NOT CLAMP THE CABLE SECURELY. IT IS NOT REPAIRABLE, AND REPLACEMENT WAS REQUESTED. THIS REPORT INVOLVES ONE (1) Ø1.7MM CABLE LOCK FOR PISTOL GRIP CABLE TENSIONER. THIS IS REPORT 1 OF 1 FOR PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15698628 ↗
• MalfunctionApr 19, 2022Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A SURGERY, THE TWO (2) CABLE LOCKS WOULD NO LONGER LOCK OR TENSION THE CABLE PROPERLY. THIS OCCURRED INTRA OP BUT SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAYS OR PATIENT ISSUES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) Ø1.7MM CABLE LOCK FOR PISTOL GRIP CABLE TENSIONER. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14142877 ↗
• MalfunctionApr 19, 2022Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A SURGERY, THE TWO (2) CABLE LOCKS WOULD NO LONGER LOCK OR TENSION THE CABLE PROPERLY. THIS OCCURRED INTRA OP BUT SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAYS OR PATIENT ISSUES. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR ONE (1) Ø1.7MM CABLE LOCK FOR PISTOL GRIP CABLE TENSIONER. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14142752 ↗
• MalfunctionApr 18, 2022Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN UNITED KINGDOM AS FOLLOWS: THIS IS REPORT 2 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) 1.7 CABLE LCK PIST GRIP CBL TENSIONER DEVICE. THIS COMPLAIN INVOLVES TWO(2) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14137925 ↗
• MalfunctionApr 5, 2022Break; Break

  DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN DENMARK AS FOLLOWS: IT WAS REPORTED THAT DURING A DEMO OF THE INSTRUMENT SET IT WAS DISCOVERED THAT A CABLE LOCK FOR PISTOL GRIP CABLE TENSIONER WAS BROKEN. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) Ø1.7MM CABLE LOCK FOR PISTOL GRIP CABLE TENSIONER . THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14016956 ↗
• MalfunctionMar 22, 2022Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM THE (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2022, THE TENSIONING GUN WORKED FINE UNTIL THE WIRE WAS PUT DOWN; THE TENSIONING GUN THEN REFUSED TO LOCK WITHOUT EXCESSIVE PRESSURE BEING USED. A SECOND TRAY WAS OPENED. PROCEDURE WAS COMPLETED WITH NO DELAY. THERE WAS NO PATIENT CONSEQUENCE. THIS REPORT IS FOR A Ø1.7MM CABLE LOCK FOR PISTOL GRIP CABLE TENSIONER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13844780 ↗
• MalfunctionMar 19, 2022Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED DURING A DEMONSTRATION PRESENTATION THERE WERE SEVERAL COMPONENTS THAT DID NOT WORK PROPERLY. THE PROVISIONAL TENSIONING DEVICE AND CABLE LOCK DID NOT LOCK THE CABLE PROPERLY; THE CABLE DID NOT TIGHTEN. THERE WERE NO PATIENT CONSEQUENCES REPORTED. THIS REPORT IS FOR A CABLE LOCK. THIS IS REPORT 2 OF 5 FOR PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13828188 ↗
• MalfunctionFeb 3, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2022, DURING AN UNKNOWN PROCEDURE, THE SURGEON WAS UNABLE TO LOCK THE CABLE TENSIONER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A NEW DEVICE. NO SURGICAL DELAY REPORTED. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13440983 ↗
• MalfunctionJul 2, 2021Mechanical Problem; Mechanical Problem

  THIS REPORT IS FOR A Ø1.7MM CABLE LOCK FOR PISTOL GRIP CABLE TENSIONER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12112182 ↗
• MalfunctionFeb 15, 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 AN UNKNOWN PROCEDURE, THE SURGEON EXPERIENCED A PROBLEM WHEN ATTEMPTING TO LOCK THE 1.7MM CABLE LOCK FOR PISTOL GRIP CABLE TENSIONER. THERE WAS NO PATIENT CONSEQUENCE. THERE WAS A SURGICAL DELAY OF ONE MINUTE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS FOR ONE (1) Ø1.7MM CABLE LOCK FOR PISTOL GRIP CABLE TENSIONER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11329856 ↗
• MalfunctionOct 13, 2020Device-Device Incompatibility; Device-Device Incompatibility

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE LOAN KIT TECHNICIAN NOTED THE CABLE LOCK AND TENSIONER INSTRUMENTS WERE NOT WORKING CORRECTLY DURING LOAN KIT INSPECTION. IT WAS DETERMINED DURING DEVICE INVESTIGATION THE DEVICES WERE JAMMED AND CAUSED A DEVICE MATING ISSUE THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10671344 ↗
• MalfunctionOct 6, 2020Mechanical Problem; Mechanical Problem

  THIS IS REPORT 1 OF 3 FOR (B)(4).

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

  MAUDE report 10639370 ↗
• MalfunctionSep 22, 2020Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING A DEMONSTRATION OF THE CABLE SYSTEM ON (B)(6) 2020, THE 1.7 MM CABLE LOCK, AND 2 PIECES OF TENSION HOLDER CANNOT HOLD THE CABLE PROPERLY. NO PATIENT OR PROCEDURE INVOLVEMENT. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN 1.7MM CABLE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10566833 ↗
• MalfunctionJun 5, 2020Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, WHEN THE SURGEON WAS TIGHTENING 1.7 MM CABLES, USING THE PISTOL GRIP GUN, THE CABLE LOCK ON THE BACK END OF THE GUN WOULD NOT STAY IN THE LOCKED POSITION. THERE WAS A FIVE (5) MINUTE SURGICAL DELAY. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: CABLE (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN), CABLE TENSIONER (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) 1.7MM CABLE LOCK FOR PISTOL GRIP CABLE TENSIONER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10122781 ↗
• MalfunctionMay 27, 2020Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020 THAT THE 1.7MM CABLE LOCK (03.221.017) IS NOT PROPERLY LOCKING WHEN BEING PUSHED FORWARD. THE CABLE IS NOT ABLE TO BE TIGHTENED SATISFACTORILY. NO PATIENT ISSUES AND ONLY A SMALL SURGICAL DELAY OF THREE (3) MINUTES. ALL PIECES ACCOUNTED FOR. THE ITEM WAS DISCARDED. THIS REPORT IS FOR ONE (1) Ø1.7MM CABLE LOCK FOR PISTOL GRIP CABLE TENSIONER. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10093641 ↗
• MalfunctionNov 13, 2019Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN ORTHOPEDIC SURGERY, THE SURGEON WAS PUTTING ON CABLES AND THE CABLE GUN KEPT SLIPPING AND NOT GRASPING THE CABLE. ANOTHER TABLE TENSIONER WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A SURGICAL DELAY OF ONE (1) MINUTE. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: UNKNOWN CABLES (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY UNKNOWN). THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS FOR ONE (1) Ø1.7MM CABLE LOCK FOR PISTOL GRIP CABLE TENSIONER. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 9317070 ↗
• MalfunctionOct 7, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING AN UNKNOWN PROCEDURE ONE (1) CABLE WITH CRIMP BROKE DURING THE INITIAL TENSIONING, ONE (1) CABLE TENSIONER WITH PISTOL GRIP, AND ONE (1) CABLE LOCK FOR PISTOL GRIP CABLE TENSIONER MALFUNCTIONED. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE AND PATIENT OUTCOME IS UNKNOWN. THIS COMPLAINT INVOLVES ONE (1) 1.7MM CABLE LOCK FOR PISTOL GRIP CABLE TENSIONER. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9163711 ↗
• MalfunctionAug 26, 2019Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2019, THE CABLE LOCK FOR PISTOL GRIP CABLE TENSIONER BECAME STIFF. THERE WAS NO DELAYS TO SURGERY OR ANY ADVERSE EFFECT TO THE PATIENT BUT THE CLIP WAS BECOMING NOTICEABLE STIFFER DURING THE OPERATION AND HARDER TO USE. THIS REPORT IS FOR ONE (1) Ø1.7MM CABLE LOCK FOR PISTOL GRIP CABLE TENSIONER THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8932276 ↗
• MalfunctionJul 3, 2019Break; Break

  IT WAS REPORTED THAT ON (B)(6) 2019, DURING A RETROGRADE INTRAMEDULLARY NAILING OF FEMUR, AS THE UNKNOWN NAIL WAS IMPLANTED AND THE AIMING ARM WAS TOOK OFF, THE NAIL WAS NOTICED TOO BURIED. THE SURGEON WAS WATCHING THE KNEE WHILE TAKING X RAYS AND NOT THE HIP, HE HIT THE NAIL DOWN TOO FAR IN THIS VIEW. THE SURGEON TRIED TO USE THE EXTRACTION BOLT BUT THE THREADS WERE TOO STRIPPED TO USE. THE NAIL WAS NOT EXPLANTED AND WAS JUST BACKED UP USING ANOTHER EXTRACTOR DEVICE. THERE WAS NO ISSUE GETTING THE INSERTION HANDLE BACK ON. UNKNOWN CABLES WERE ALSO USED AND WENT TO INSERT A 1.7 CABLE THROUGH THE GUN BUT IT WOULD NOT PASS. SOMETHING HAPPENED TO THE 1.7 CABLE LOCK AND WAS JAMMED AND BROKEN. BACKUP DEVICES WERE AVAILABLE. THERE WAS A 2 MINUTE SURGICAL DELAY. PROCEDURE WAS SUCCESSFULLY COMPLETED. PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNKNOWN AIMING ARM (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1), UNKNOWN INSERTION HANDLE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1), UNKNOWN CABLE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1), UNKNOWN TENSIONING INSTRUMENT (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 1). THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8757791 ↗
• MalfunctionApr 12, 2019Break; Break

  IT WAS REPORTED ON AN UNKNOWN DATE, THE CABLE LOCK FOR PISTOL GRIP CABLE TENSIONER WAS NOT FUNCTIONING PROPERLY. THE DEVICE IS FOR THE TABLE SET AND A FIELD INVENTORY. THE CABLE TENSIONER IS USELESS WITHOUT THE LOCKING MECHANISM OF THE CABLE LOCK IN ORDER TO USE THE TENSIONER ON THE TABLE. THERE WAS NO PATIENT INVOLVEMENT. CONCOMITANT DEVICES REPORTED: UNKNOWN CABLE TENSIONER (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY 1). THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Patient Involvement

  MAUDE report 8511295 ↗