NA 391.884Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10886982198365), received between Dec 16, 2016 and Jan 3, 2023 — classified as 31 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (19 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 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 3, 2023Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THERE WERE PROBLEMS WITH THE CABLE TENSIONER ONE HAND PIECE AND A TENSION HOLDER FOR TEMPORARY USE. NO PATIENT WAS INVOLVED. THE GUN WAS SLIPPING AND THE TENSION HOLDER FOR TEMPORARY USE DIDN¿T ACCEPT THE ATTACHMENT OF IT ANYMORE, AS IT HAD A SPRING THAT WAS WORN OUT. THE PROBLEM WAS NOTICED ON (B)(60 2022 IN CF AND PREVIOUS USAGE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT INVOLVES ONE PROVISIONAL TENSIONING DEVICE. THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16085213 ↗
• 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 (1) PROVISIONAL TENSIONING DEVICE. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16080632 ↗
• MalfunctionJul 18, 2022Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ON (B)(6)2022, WHILE INSPECTING THE INSTRUMENTS AFTER GOING THROUGH THE DECONTAMINATION PROCESS, THERE WERE SEVERAL DEVICES DAMAGED. THE T-HANDLE CHUCK AND THE HANDLE BENT. THE POWER SHAFT SCREWDRIVER AND THE TIP STRIPPED. THERE WAS A LONG REAMER SHAFT AND THE REAMER HEADS WILL NOT FIT/ATTACH AND THE THE 2.5MM REAMING ROD KEEPS GETTING CAUGHT IN IT. THE CABLE TENSIONING ATTACHMENT WILL NOT STAY ON THE TENSIONER. THERE WAS ALSO A LOCKING SMALL FRAG TRAY INSERT. ONE OF THE HANDLES ON THE TRAY IS BROKEN. THERE IS NO PATIENT OR SURGICAL INVOLVEMENT. THIS IS REPORT 3 OF 3 FOR (B)(4). THIS REPORT IS FOR A TENSIONING DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15040584 ↗
• MalfunctionApr 18, 2022Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE SPRING ON THE TENSIONING DEVICE BROKE. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED SUCCESSFULLY. HOWEVER, THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) PROVISIONAL TENSIONING DEVICE. THIS COMPLAINT INVOLVES TWO (2) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14137610 ↗
• MalfunctionApr 18, 2022Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE SPRING ON THE TENSIONING DEVICE BROKE. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED SUCCESSFULLY. HOWEVER, THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS REPORT IS FOR ONE (1) PROVISIONAL TENSIONING DEVICE. THIS COMPLAINT INVOLVES TWO (2) DEVICES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14137605 ↗
• MalfunctionMar 20, 2022Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES (B)(4) 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 TENSION HOLDER. THIS IS REPORT 5 OF 5 FOR PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13828713 ↗
• MalfunctionMar 20, 2022Mechanical Problem; Mechanical Problem

  DEVICE REPORT FROM SYNTHES (B)(4) 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 TENSION HOLDER. THIS IS REPORT 4 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13828627 ↗
• MalfunctionMar 20, 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 TENSION HOLDER. THIS IS REPORT 3 OF 5 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13828354 ↗
• 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 TENSION HOLDER. THIS IS REPORT 1 OF 5 FOR PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13828096 ↗
• 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 NOVEMBER 15, 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) PROVISIONAL TENSIONING DEVICE. THIS IS REPORT 4 OF 7 FOR COMPLAINT PC-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13266028 ↗
• 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) PROVISIONAL TENSIONING DEVICE. THIS IS REPORT 5 OF 7 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13266025 ↗
• 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) PROVISIONAL TENSIONING DEVICE. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12983211 ↗
• MalfunctionFeb 5, 2021Break; Break

  DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 DURING A PERIPROSTHETIC FRACTURE, THE TWO INSTRUMENTS DID NOT WORK ADEQUATELY BECAUSE THEY WERE BROKEN. THERE WAS NO SURGICAL DELAY REPORTED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS FOR ONE (1) PROVISIONAL TENSIONING DEVICE. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11288661 ↗
• 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 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 2) ATTACHM-BIT F/TENSION HOLDER (PART NUMBER 391.883, LOT UNKNOWN, QUANTITY 3) CERCL-CABLE W/CRIMP Ø1.7 (P

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11284886 ↗
• 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 2). ATTACHM-BIT F/TENSION HOLDER (PART NUMBER 391.883, LOT UNKNOWN, QUANTITY 3). CERCL-CABLE W/CRIMP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11281263 ↗
• 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 2). ATTACH-BIT F/TENSION HOLDER (PART NUMBER 391.883, LOT UNKNOWN, QUANTITY 3). CERCL-CABLE W/CRIMP

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11281183 ↗
• 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 DEVICE REPORTED: UNKNOWN 1.7MM CABLE (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY UNKNOWN). THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10566903 ↗
• 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 DEVICE REPORTED: UNKNOWN 1.7MM CABLE (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY UNKNOWN). THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10566797 ↗
• MalfunctionJun 23, 2020Mechanical Problem; Mechanical Problem

  EVENT UPDATE: EVENT OCCURRED INTRAOPERATIVELY ON (B)(6) 2020.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10184670 ↗
• MalfunctionDec 31, 2019Break; Break

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, A PROVISIONAL TENSIONING DEVICE WOULD NOT RETAIN- THE TOP DOESN¿T STAY ON, AND IT APPEARED THAT THE SPRING INSIDE HAD BEEN BROKEN. THE ISSUE HAPPENED BEFORE SURGERY WHILE ASSEMBLING THE CABLE SYSTEM FOR A CASE. THEY OPENED UP A SECOND SET. THERE WAS NO PATIENT INVOLVEMENT. UNKNOWN CABLE SYSTEM (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS IS REPORT 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9536355 ↗
• MalfunctionJun 10, 2019Mechanical Problem; Mechanical Problem

  8/8/2019: UPDATED EVENT DESCRIPTION: DEVICE REPORT FROM CANADA REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, A TENSION HOLDER DEPTH WAS NOT GRIPPING THE ATTACHMENT BIT AND WAS SLIPPING OFF. THE CASE WAS NOT IMPACTED AS THERE WERE ANOTHER THREE (3) TENSION HOLDER IN THE SET. PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: ATTACHMENT BIT (PART NUMBER: 391.883; LOT NUMBER: UNKNOWN; QUANTITY: 1) . THIS COMPLAINT INVOLVES ONE (1) DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8682495 ↗
• MalfunctionMar 13, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE. THE TWO (2) SPRINGS WERE DISCOVERED TO BE BROKEN PREOPERATIVELY AND WERE REMOVED FROM THE PROVISIONAL TENSIONING DEVICE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE OUTCOME AND PATIENT STATUS WERE UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 1 OR 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8418861 ↗
• MalfunctionMar 13, 2019Break; Break

  DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT AN ORTHOPEDIC PROCEDURE. THE TWO (2) SPRINGS WERE DISCOVERED TO BE BROKEN PREOPERATIVELY AND WERE REMOVED FROM THE PROVISIONAL TENSIONING DEVICE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE OUTCOME AND PATIENT STATUS WERE UNKNOWN. THIS COMPLAINT INVOLVES TWO (2) DEVICES. THIS REPORT IS 2 OR 2 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8418859 ↗
• MalfunctionMar 12, 2019Mechanical Problem; Mechanical Problem

  ADDITIONAL CONCOMITANT DEVICE: CABLE TENSIONER (PART/LOT UNKNOWN, QUANTITY UNKNOWN).

  Patient problems: No Patient Involvement

  MAUDE report 8411539 ↗
• MalfunctionMar 12, 2019Mechanical Problem; Mechanical Problem

  ADDITIONAL CONCOMITANT DEVICE: CABLE TENSIONER (PART/LOT UNKNOWN, QUANTITY UNKNOWN).

  Patient problems: No Patient Involvement

  MAUDE report 8411526 ↗