RIGIDFIX 213701Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10886705002955), received between Jul 11, 2018 and Oct 29, 2025 — classified as 30 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 29, 2025Break; Break

  IT WAS REPORTED THAT DURING POST SURGERY FOR AN ANTERIOR CRUCIATE LIGAMENT SURGICAL PROCEDURE, IT WAS OBSERVED THAT WHEN THE RIGIDFIX FEM GDEFR S/T *EA DEVICE WAS IN THE FEMORAL TUNNEL, THE KNOB THAT WAS USED TO FIXATE THE 10MM ROD INTO THE NEW FRONT GUIDE WAS BROKEN OFF. IT WAS REPORTED THAT THE CASE WAS COMPLETED USING RIGID FIX SOFT TISSUE GUIDE AND ROD HOWEVER WERE UNABLE TO GET THE ROD OUT BECAUSE THE SCREW WAS BROKEN OFF IN IT AND IT DID NOT FLUSH AND COULD NOT GET THE SCREW OUT. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23412413 ↗
• MalfunctionAug 27, 2024Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT BEFORE A KNEE SCOPE PROCEDURE, IT WAS DISCOVERED THAT THE TRAP DOOR ON THE RIGIDFIX FEMORAL ST GUIDE FRAME DEVICE, WHERE THE TROCARS PASS THROUGH WAS NOT SCREWED ON CORRECTLY. IT WAS REPORTED THAT THERE WERE NO DELAYS TO THE SURGICAL PROCEDURE AS A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20077454 ↗
• MalfunctionJul 12, 2024Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS OBSERVED THAT THE RIGIDFIX FEMROD 10MM DEVICE AND THE RIGIDFIX FEM GDEFR S/T DEVICE WERE STUCK TOGETHER; AND THEREFORE, COULD NOT BE USED. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19730536 ↗
• MalfunctionDec 11, 2023Material Deformation; Material Deformation

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR PROCEDURE ON 11/28/2023, IT WAS OBSERVED THAT THE RIGIDFIX FEMORAL ST GUIDE FRAME N/S 1PK WAS BENT/TORQUED AND THE DRILL SLEEVES AND TROCAR WERE BEING PREVENTED FROM CROSSING THE WINDOW OF THE RIGIDFIX FEMORAL ROD 9 MM 1PK. THE DISTAL SLEEVE EVENTUALLY WENT ACROSS. THE PHYSICIAN TRIED TO REPOSITION THE GUIDE FOR THE PROXIMAL PIN, AFTER REAPPROXIMATING THE GUIDE AT A DIFFERENT ANGLE, AND REDRILLING, THEY WERE ABLE TO GET THE PROXIMAL PIN THROUGH THE FRAME. THE SKIVE MARKS WERE VISIBLE IN THE SLEEVE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18301043 ↗
• MalfunctionDec 16, 2022Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN SURGERY ON 11/18/2022, IT WAS OBSERVED THAT A DRILL BIT AND A CANNULA DEVICES WOULD NOT FIT INTO THE OPENING ON THE RIGIDFIX FEMORAL ST GUIDE FRAME N/S 1PK DEVICE CAUSING THE BARBED WIRES TO COLD WELD TO THE CANNULA. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A SURGICAL DELAY OF FIVE MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15997558 ↗
• MalfunctionFeb 11, 2022Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN SURGERY ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE RIGIDFIX FEM GDEFR S/T DEVICE WAS NOT ALLOWING TROCAR TO GO INSIDE. THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13514594 ↗
• MalfunctionSep 13, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT POSTOPERATIVELY TO AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE SCREW ON THE RIGIDFIX FEM GDEFR S/T DEVICE BROKE OFF WITH THE SUTURE THREADS STILL IN THE GUIDE. THE PROCEDURE WAS ALREADY COMPLETED WHEN THIS HAPPENED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12463421 ↗
• MalfunctionApr 6, 2021Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT AFTER THE CLEANING PROCESS, IT WAS OBSERVED THAT THE GUIDEWIRE DEVICE WAS BENT. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11622929 ↗
• MalfunctionApr 5, 2021Material Deformation; Material Deformation

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE PINS ON THE BONE NAIL GUIDEWIRE DEVICE WERE BENT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF FIVE MINUTES. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11615559 ↗
• MalfunctionJan 22, 2021Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A KIDNEY PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE RIGIDFIX FEMORAL ST GUIDE FRAME N/S 1PK DEVICE HAD A WELDING PIECE INSIDE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A TEN MINUTE DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11214878 ↗
• MalfunctionSep 30, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY J&J EMPLOYEE VIA EMAIL INFORMED US THAT THE CANNULATION OF THE RIGIDFIX FEM GDEFR S/T EA BLOCKED WHEN DRILLING IN THE GUIDE. THIS RESULTED IN A SURGICAL DELAY OF 3 MINUTES. A SECOND IMPLANT (PRODUCT CODE 210816) HAD TO BE USED AND THE GUIDE WAS SET MANUALLY. NO PATIENT CONSEQUENCE THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: Not Applicable

  MAUDE report 10610612 ↗
• MalfunctionOct 14, 2019Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL PROCEDURE THE PINS WERE GETTING STUCK WHEN DRILLING THROUGH THE CUSTOMER'S RIGIDFIX FEMORAL ST GUIDE FRAME. THE SALES REP STATED THAT THE PLATE ON THE DEVICE IS NOT FLAT ANY LONGER. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE WITH NO PATIENT HARM OR SURGICAL DELAY TO THE CASE. THE DEVICE WILL BE RETURNING FOR EVALUATION. THIS COMPLAINT IS FOR ONE (1) RIGIDFIX FEMORAL ST GUIDE FRAME N/S 1PK. THIS REPORT IS 1 OF 1 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9188102 ↗
• MalfunctionSep 25, 2019Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT THE RIGIDFIX FEM GDEFR S/T *EA DEVICE BROKE DURING ACL RECONSTRUCTION PROCEDURE. ACCORDING TO THE REPORTER, AFTER REAMING INTO THE FEMUR AND TIBIA, A 9MM AIMING GUIDE WAS SCREWED INTO RIGIDFIX U-SHAPED GUIDE. WHILE TIGHTENING THE BOLT ON THE U-SHAPED GUIDE TO THE 9MM AIMING GUIDE, THE BOLD BROKE OFF LEAVING A PIECE OF THE BOLT INSIDE THE U-SHAPED GUIDE CAUSING THE 9MM AIMING GUIDE TO BE STUCK INSIDE THE U-SHAPED GUIDE. NO ADVERSE EFFECTS OCCURRED NOR ANY EXTENDED PROCEDURE TIME. SECURED THE AIMING GUIDE TO THE OPPOSITE SIDE OF THE U-SHAPED GUIDE WITH ANOTHER BOLT. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9117731 ↗
• MalfunctionSep 23, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL PROCEDURE WHEN BACK MALLETING THE CUSTOMER'S RIGIDFIX FEMORAL ST GUIDE FRAME TO REMOVE THE DEVICE FROM THE PATIENT, THE SURGEON ACCIDENTALLY HIT THE THUMB SCREW CAUSING IT TO BREAK. THE CUSTOMER'S RIGIDFIX FEMORAL ROD 10MM IS NOW STUCK IN THE GUIDE DUE TO THE THUMB SCREW BREAKING AND ARE NOT ABLE TO DISASSEMBLE THE DEVICES. THE PROCEDURE HAD BEEN COMPLETED WITH THE DEVICES BEFORE THE ISSUE OCCURRED WITH NO HARM TO THE PATIENT OR DELAYS TO THE CASE. THE SALES REP CONFIRMED THAT NOTHING FELL IN THE PATIENT AND WHERE THE DEVICE BROKE STAYS OUTSIDE THE PATIENT. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9104367 ↗
• MalfunctionSep 16, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL PROCEDURE THE THUMB SCREW ON THEIR RIGIDFIX FEMORAL ST GUIDE FRAME BROKE. THE SALES REP STATED THAT WHERE THE DEVICE BROKE STAYS OUTSIDE THE PATIENT THEREFORE NO DEBRIS FELL IN THE PATIENT. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE DEVICE WITH NO HARM TO THE PATIENT OR DELAYS TO THE CASE. THE SALES REP COULD NOT PROVIDE A LIT NUMBER FOR THE DEVICE BUT STATED THAT THE DEVICE IS OVER TEN YEARS OLD AND HAS SEEN HEAVY USE IN THE FIELD. THE SALES REP STATED THAT THE DEVICE WAS DISCARDED BY THE CUSTOMER. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE. THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9069602 ↗
• MalfunctionMay 30, 2019Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) VIA EMAIL THAT DURING A KNEE SURGERY PROCEDURE THE RIGIDFIX FEMORAL GUIDE FRAME METAL SLEEVE JAMMED AND GOT TRAPPED; THEREFORE, THE CROSS PIN COULD NOT BE PLACED. THERE WAS A DELAY OF 2-5 MINUTES TO ADJUST THE DEVICE AND STARTED AGAIN. THERE WAS A DELAY IN THE SURGICAL PROCEDURE. THERE WAS A SPARE DEVICE AVAILABLE FOR USE TO COMPLETE THE SURGERY. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 8655068 ↗
• MalfunctionFeb 26, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL RECONSTRUCTION PROCEDURE THE SALES REP'S RIGIDFIX FEMORAL GUIDE FRAME THUMB SCREW WAS BEING TAPPED WITH A MALLET WHEN IT BROKE OFF FROM THE DEVICE. THE SALES REP STATED THAT THE BREAKAGE OCCURRED OUTSIDE OF THE PATIENT AND THEREFORE NOTHING FELL INTO THE PATIENT CAVITY. THE CASE WAS COMPLETED WITH THIS DEVICE, AS THERE WAS A TIGHT FIT SO NO ADDITIONAL ISSUES AROSE. THERE WAS NO PATIENT HARM OR TIME DELAY. THE SALES REP COULD NOT PROVIDE A LOT NUMBER. THE DEVICE IS BEING RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8369804 ↗
• MalfunctionFeb 8, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE THAT DURING AN UNKNOWN PROCEDURE THUMBSCREW BROKE: RIGIDFIX SCREW BROKE WHILE TIGHTENING THE ROD INTO THE RIGIDFIX FEMORAL GUIDE FRAME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8322878 ↗
• MalfunctionJan 28, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A LEFT ANTERIOR CRUCIATE LIGAMENT ACL RECONSTRUCTION SOFT TISSUE SURGICAL PROCEDURE, DURING USE OF THE 'RIGIDFIX SOFT TISSUE GUIDE' INSTRUMENT TO PLACE THE SINGLE USE TROCARS FROM A 'RIGIDFIX FEMORAL ST CROSS PIN KIT' VIA DRILL POWER, IT WAS OBSERVED THAT THE GUIDE AND TROCAR HAVE COLD WELDED TOGETHER. THE SURGEON WAS UNABLE TO ADVANCE THE TROCAR INTO THE APPROPRIATE POSITION. THERE WAS NO HARM CAUSED TO THE PATIENT. THERE WAS VISUAL DAMAGE NOTED TO THE INSTRUMENT AND TROCAR. THE GUIDE AND TROCAR WERE REMOVED AND A SECOND 'RIGIDFIX SOFT TISSUE GUIDE' INSTRUMENT AND 'RIGIDFIX FEMORAL ST CROSS PIN KIT' WERE OPENED AND USED SUCCESSFULLY TO COMPLETE THE CASE. THERE WAS A DELAY IN THE SURGICAL PROCEDURE OF 10 MINUTES. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8282082 ↗
• MalfunctionJan 24, 2019Break; Physical Resistance/Sticking; Break; Physical Resistance/Sticking

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT ACL PROCEDURE, IT WAS OBSERVED THAT THE THUMB SCREW BROKE OFF THE CUSTOMER'S RIGIDFIX FEMORAL SOFT TISSUE GUIDE FRAME AND IT COLD WELDED TOGETHER WITH RIGIDFIX FEMORAL ROD 10MM. THE SALES REP STATED WHERE THE SCREW BROKE OFF STAYS OUTSIDE THE PATIENT THEREFORE NOTHING FELL IN THE PATIENT. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE DEVICES WITH NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP COULD NOT PROVIDE A LOT NUMBER FOR THE FEMORAL ROD BUT STATED IT IS AN OLDER DEVICE. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE AS THE SAME DEVICES WERE USED TO COMPLETE THE PROCEDURE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8275952 ↗
• MalfunctionJan 23, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THIS IS REPORT 2 OF 4 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT THE CUSTOMER'S RIGIDFIX FEMORAL 3.3MMST CROSS PIN KIT, RIGIDFIX FEMORAL ST GUIDE FRAME, RIGIDFIX FEMORAL/TIBIAL ROD THUMB SCREW FAILED DURING AN ANTERIOR CRUCIATE LIGAMENT ACL RECONSTRUCTION SURGICAL PROCEDURE. IT WAS REPORTED THAT THE SURGEON PLACED THE GUIDE FRAME IN AND THEY BINDED UP THEN COLD WELDED BUT WAS UNABLE TO TAKE APART. THE SURGEON STATED THAT ALL OF THE DEVICES LOOKED TOO BIG AND NOT WORKING CORRECTLY. THE CASE WAS COMPLETED WITH ANOTHER LIKE DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES OR TIME DELAY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8271374 ↗
• MalfunctionJan 22, 2019Break; Break

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT ACL RECONSTRUCTION SURGICAL PROCEDURE, AFTER REMOVING THE SOFT TISSUE U-SHAPED GUIDE FROM THE PATIENT'S KNEE, THE TECH IN THE BACK TABLE TRIED TO UNSCREW THE 8MM ROD FROM THE SOFT TISSUE GUIDE AND THE BOLT THAT HOLDS BOTH GUIDES TOGETHER BROKE OFF; LEAVING THE 8MM GUIDE ATTACHED TO THE SOFT TISSUE GUIDE. TOURNIQUET TIME WAS NOT AFFECTED FROM THE NORM. THE GUIDE WAS NO LONGER NEEDED DURING THAT CASE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8266723 ↗
• MalfunctionJan 21, 2019Fracture; Fracture

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT ACL SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE THUMB SCREW BROKE OFF CAUSING THEIR RIGIDFIX FEMORAL ROD 7.5MM AND THEIR RIGIDFIX FEMORAL ST GUIDE FRAME TO BE STUCK TOGETHER. THE SALES REP STATED THAT THEY ARE UNABLE TO GET THE BROKEN PIECE OUT THAT ARE CAUSING THE TWO PIECES TO BE REMOVED FROM ONE ANOTHER. THE SALES REP REPORTED THAT THE SURGEON HAD COMPLETED THE PROCEDURE WITH THE DEVICE BEFORE THE DEVICE FAILURE OCCURRED. THE SALES REP REPORTED THAT THERE WERE NO PATIENT CONSEQUENCES OR DELAYS IN THE PROCEDURE. THE SALES REP STATED THAT WHERE THE DEVICE BROKE STAYS OUTSIDE THE PATIENT. THE SALES REP CONFIRMED THAT NOTHING BROKE OR FELL IN THE PATIENT. THE SALES REP COULD NOT PROVIDE ANY LOT NUMBERS FOR THE DEVICES BUT STATED THAT THE DEVICES ARE OVER FIVE YEARS OLD AND HAVE SEEN HEAVY USE IN THE FIELD. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8264793 ↗
• MalfunctionDec 19, 2018Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE DRILL SLEEVE WITH TROCAR OF THE DEVICE HAS TILTED INTO GUIDE FRAME. THE SLEEVE SHOWED GRINDING MARKS AND THE GUIDE FRAME WAS ALSO ROUGHENED. THERE WAS NO PATIENT HARM OR SURGICAL DELAY REPORTED AND THE SURGERY WAS COMPLETED NORMALLY. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8179651 ↗
• MalfunctionOct 22, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL REPAIR PROCEDURE THE SALES REP'S RIGIDFIX FEMORAL GUIDE HAD THE THUMB SCREW BREAK INSIDE THE GUIDE. THE BREAK IN THE SCREW HAPPENED OUTSIDE OF THE PATIENT WITH NO FRAGMENTS CREATED. THE SALES REP'S 8.5 RIGIDFIX FEMORAL ROD IS JAMMED IN THE GUIDE BECAUSE THE SCREW CANNOT BE REMOVED FROM THE GUIDE. THE CASE WAS COMPLETED WITH THIS DEVICE WITH NO PATIENT HARM OR DELAYS. THE DEVICES ARE BEING RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7991974 ↗