NA 391.883Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10886982198358), received between Oct 12, 2018 and Jan 17, 2023 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 17, 2023Crack; Device-Device Incompatibility; Crack; Device-Device Incompatibility

  IT WAS REPORTED THAT ON UNKNOWN DATE, THAT THE TENSIONING INSTRUMENT WAS UNABLE TO STERILIZE/ASSEMBLE. THERE WAS CHIPPING AND CRACKING AS IT WAS UNABLE TO BE USE. THIS COMPLAINT INVOLVES ONE (1) DEVICE. THIS REPORT IS FOR ONE (1) ATTACHMENT BIT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16189308 ↗
• MalfunctionJan 17, 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, 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) ATTACHMENT BIT. THIS IS REPORT 6 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13266029 ↗
• MalfunctionJan 17, 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, 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) ATTACHMENT BIT. THIS IS REPORT 7 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13266024 ↗
• 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 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) ATTACHMENT BIT. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12983156 ↗
• MalfunctionFeb 5, 2021Mechanical Problem; Mechanical Problem

  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 SURGERY FOR THE SUBTROCHANTERIC FRACTURE OF THE LEFT FEMUR WITH THE TENSION IMPLANTS AND INSTRUMENTS. THE SURGEON TRIED TO APPLY TENSION TO THE CABLE USING THE TENSIONER ACCORDING TO THE SURGICAL TECHNIQUE, BUT WHEN HE APPLIED 20 KG OF TENSION, THE KNOB OF THE TENSIONER DID NOT MOVE TO THE RIGHT AND HE COULD NOT APPLY ANY MORE TENSION. HE WASHED THE INSIDE OF THE TENSIONER WITH A SALINE SOLUTION, CHANGED THE TENSION HOLDER AND ATTACHMENT BIT, AND TRIED AGAIN, BUT THE TENSION WAS APPLIED ONLY UP TO 25 KG TO 30 KG. THE SURGEON GAVE UP USING THE CABLES, CONDUCTED WIRING USING MILD STEEL WIRES IN THE HOSPITAL, INSERTED TFNA LONG, AND COMPLETED THE SURGERY WITH A THIRTY (30) MINUTE DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS REPORTED AS STABLE. CONCOMITANT DEVICES REPORTED: CABLE TENSIONER (PART NUMBER 391.201, LOT UNKNOWN, QUANTITY 1). TENSION HOLDER F/TEMP-USE (PART NUMBER 391.884, LOT UNKNOWN, QUANTITY 3). ATTACHM-BIT F/TENSION HOLDER (PART NUMBER 391.883, LOT UNKNOWN, QUANTITY 2). CERCL-CABLE W/CRIMP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11284895 ↗
• MalfunctionFeb 4, 2021Mechanical Problem; Mechanical Problem

  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 SURGERY FOR THE SUBTROCHANTERIC FRACTURE OF THE LEFT FEMUR WITH THE TENSION IMPLANTS AND INSTRUMENTS. THE SURGEON TRIED TO APPLY TENSION TO THE CABLE USING THE TENSIONER ACCORDING TO THE SURGICAL TECHNIQUE, BUT WHEN HE APPLIED 20 KG OF TENSION, THE KNOB OF THE TENSIONER DID NOT MOVE TO THE RIGHT AND HE COULD NOT APPLY ANY MORE TENSION. HE WASHED THE INSIDE OF THE TENSIONER WITH A SALINE SOLUTION, CHANGED THE TENSION HOLDER AND ATTACHMENT BIT, AND TRIED AGAIN, BUT THE TENSION WAS APPLIED ONLY UP TO 25 KG TO 30 KG. THE SURGEON GAVE UP USING THE CABLES, CONDUCTED WIRING USING MILD STEEL WIRES IN THE HOSPITAL, INSERTED TFNA LONG, AND COMPLETED THE SURGERY WITH A THIRTY (30) MINUTE DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS REPORTED AS STABLE. CONCOMITANT DEVICES REPORTED: CABLE TENSIONER (PART NUMBER 391.201, LOT UNKNOWN, QUANTITY 1). TENSION HOLDER F/TEMP-USE (PART NUMBER 391.884, LOT UNKNOWN, QUANTITY 3). ATTACHM-BIT F/TENSION HOLDER (PART NUMBER 391.883, LOT UNKNOWN, QUANTITY 2). CERCL-CABLE W/CRIMP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11281270 ↗
• MalfunctionFeb 4, 2021Mechanical Problem; Mechanical Problem

  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 SURGERY FOR THE SUBTROCHANTERIC FRACTURE OF THE LEFT FEMUR WITH THE TENSION IMPLANTS AND INSTRUMENTS. THE SURGEON TRIED TO APPLY TENSION TO THE CABLE USING THE TENSIONER ACCORDING TO THE SURGICAL TECHNIQUE, BUT WHEN HE APPLIED 20 KG OF TENSION, THE KNOB OF THE TENSIONER DID NOT MOVE TO THE RIGHT AND HE COULD NOT APPLY ANY MORE TENSION. HE WASHED THE INSIDE OF THE TENSIONER WITH A SALINE SOLUTION, CHANGED THE TENSION HOLDER AND ATTACHMENT BIT, AND TRIED AGAIN, BUT THE TENSION WAS APPLIED ONLY UP TO 25 KG TO 30 KG. THE SURGEON GAVE UP USING THE CABLES, CONDUCTED WIRING USING MILD STEEL WIRES IN THE HOSPITAL, INSERTED TFNA LONG, AND COMPLETED THE SURGERY WITH A THIRTY (30) MINUTE DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY AND THE PATIENT WAS REPORTED AS STABLE. CONCOMITANT DEVICES REPORTED: CABLE TENSIONER (PART NUMBER 391.201, LOT UNKNOWN, QUANTITY 1)TENSION HOLDER F/TEMP-USE (PART NUMBER 391.884, LOT UNKNOWN, QUANTITY 3)ATTACHM-BIT F/TENSION HOLDER (PART NUMBER 391.883, LOT UNKNOWN, QUANTITY 2)CERCL-CABLE W/CRIMP Ø1.7

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11281219 ↗
• MalfunctionOct 12, 2018Mechanical Problem; Device-Device Incompatibility; Mechanical Problem; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF THE FEMUR ON (B)(6) 2018, THREE (3) HANDLES FOR PERCUTANEOUS THREADED DRILL WERE STRIPPED OUT AND WOULD NOT THREAD INTO THE DRILL GUIDE. ON ONE (1) PERCUTANEOUS THREADED DRILL, THE THREADS WERE STRIPPED AND THE HANDLE WOULD NOT THREAD IN. ONE (1) CABLE TENSIONER, ONE (1) PROVISIONAL TENSIONING DEVICE AND ONE (1) ATTACHMENT BIT WERE USED SIMULTANEOUSLY TO TENSION THE CABLE. THE SURGEON TRIED TO TENSION THE CABLE WITHOUT PULLING THE SLACK FIRST. THE CABLE GOT BOUND IN THE TENSION DEVICE AND WILL NOT COME OUT. SPARE DEVICES WERE AVAILABLE, AND THE SURGERY WAS COMPLETED WITH A FIVE TO SEVEN (5-7) MINUTE SURGICAL DELAY. PATIENT OUTCOME IS UNKNOWN. THIS REPORT IS FOR AN ATTACHMENT BIT. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7960190 ↗