RIGIDFIX 213600Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10886705002634), received between Nov 26, 2018 and Apr 1, 2024 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 1, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP IN PORTUGAL THAT ON 1/1/2024 THE RIGIDFIX FEM/TIB ROD THUMBSCR *EA DEVICE SCREW WAS BROKEN. IT WAS UNKNOWN WHEN THE EVENT OCCURRED. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19015494 ↗
• MalfunctionOct 18, 2023Break; Device-Device Incompatibility; Break; Device-Device Incompatibility

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2023 THE RIGIDFIX FEM/TIB ROD THUMBSCR DEVICE SCREW BROKE AND THE OTHER HALF WAS STUCK IN THE GUIDE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17960644 ↗
• MalfunctionApr 17, 2023Break; Break

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE AFFILIATE IN ITALY THAT THERE WAS RUPTURE OF THE RIGIDFIX FEMORAL/TIBIAL ROD THUMB SCREW INTO THE RIGIDFIX FEMORAL BTB GUIDE FRAME N/S DEVICE WHILE IN USE TOGETHER. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16756014 ↗
• MalfunctionMar 8, 2023Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE AFFILIATE IN ITALY THAT THE RIGIDFIX FEMORAL/TIBIAL ROD THUMB SCREW DEVICE BROKE DUE TO OPERATORS HITTING IT WITH A HAMMER. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16504595 ↗
• MalfunctionJan 9, 2023Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN ITALY THAT THE RIGIDFIX FEMORAL/TIBIAL ROD THUMB SCREW DEVICE WAS BROKEN. THERE WAS NO PROCEDURE NOR PATIENT INVOLVEMENT REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16121862 ↗
• MalfunctionNov 14, 2022Break; Break

  IT WAS REPORTED BY SALES REP THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE RIGIDFIX FEMORAL/TIBIAL ROD THUMB SCREW DEVICE SNAPPED OFF WHILE IN USE WITH THE GUIDE DEVICE. ACCORDING TO THE REPORT, THE BROKEN PIECE FELL ON THE FLOOR AND THE REMAINING THREADS WERE STILL IN THE DEVICE. IT WAS REPORTED THAT THEY WERE ABLE TO FINISH THE CASE WITH THE DEVICE BUT WERE NOT ABLE TO TAKE THE DEVICE APART. NO SURGICAL DELAY OR PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15790084 ↗
• MalfunctionFeb 18, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE SCREW THAT CLAMPED DOWN THE DILATOR DID NOT WANT TO SCREW INTO THE HOLE, AND PROPERLY CLAMP DOWN THE GUIDE ON THE RIGIDFIX FEM/TIB ROD THUMBSCR DEVICE. 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 13560180 ↗
• MalfunctionJan 15, 2020Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ACL PROCEDURE THE RIGIDFIX FEMORAL/TIBIAL ROD THUMB SCREW BROKE. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY WAS REPORTED. NO FRAGMENTS WERE GENERATED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9593400 ↗
• MalfunctionNov 14, 2019Break; Break

  IT WAS REPORTED THAT POST-OPERATIVELY TO AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2019, THE THUMB SCREW ON THE CUSTOMER'S RIGIDFIX TIBIAL GUIDE FRAME BROKE OFF CAUSING THE RIGID TIBIAL ROD 10MM TO BECOME STUCK TOGETHER WITH THE GUIDE. THIS OCCURRED DURING CLEANING OF THE DEVICE. IT WAS NOTED THAT THE DEVICES ARE OVER TEN YEARS OLD AND HAVE SEEN HEAVY USE IN THE FIELD. THIS IS REPORT 3 OF 3 FOR (B)(4).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9321670 ↗
• MalfunctionMar 14, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL RECONSTRUCTION PROCEDURE THE SALES REP'S RIGIDFIX FEMORAL THUMB SCREW BROKE OFF THE RIGIDFIX FRAME. THE SALES REP DID NOT KNOW WHAT CAUSED THE THUMB SCREW TO BREAK, BUT BREAKAGE OCCURRED OUTSIDE OF THE PATIENT CAVITY WITH NO FRAGMENTS CREATED. THE BREAKAGE OF THE THUMB SCREW DID NOT INTERRUPT THE CASE AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT HARM OR DELAY. THE SALES REP COULD NOT PROVIDE A LOT NUMBER FOR THE DEVICE. THE DEVICE WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8421517 ↗
• MalfunctionJan 23, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  THIS IS REPORT 3 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 8271372 ↗
• MalfunctionNov 26, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL RECONSTRUCTION PROCEDURE THE CUSTOMER'S RIGIDFIX FEMORAL ROD 7MM, RIGIDFIX FEMORAL ROD 8MM, RIGIDFIX FEMORAL ROD 9MM, AND RIGIDFIX FEMORAL ROD 10MM HAD FADED LASER LINES, WHICH CAUSED ISSUES READING THE LETTERING ON THE DEVICES. THE CUSTOMER'S FIRST RIGIDFIX FEMORAL/TIBIAL ROD THUMB SCREW WAS MALLETED INTO THE GUIDE WHEN IT BROKE IN THE GUIDE. THE BREAKAGE HAPPENED OUTSIDE THE PATIENT AND THERE WERE NO FRAGMENTS IN THE PATIENT. THE CUSTOMER'S SECOND RIGIDFIX FEMORAL/TIBIAL ROD THUMB SCREW BENT WHERE THE SCREW MEETS THE THUMB HEAD. THE SCREW BENT WHILE INSERTING INTO THE GUIDE. THE CUSTOMER'S RATCHET HANDLE WITH JACOB'S CHUCK WOULD NOT HOLD THE DRIVER. THE CASE WAS COMPLETED USING THE RIGIDFIX FEMORAL ROD 10MM, THE SECOND RIGIDFIX FEMORAL/TIBIAL ROD THUMB SCREW, AND AN ALTERNATIVE FIXED HANDLE DRIVER. THE SALES REP STATED THAT THERE WAS NO PATIENT HARM OR DELAYS. THE SALES REP COULD NOT PROVIDE LOT NUMBERS FOR ANY OF THE DEVICES. THE DEVICES ARE BEING RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8104598 ↗
• MalfunctionNov 26, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL RECONSTRUCTION PROCEDURE THE CUSTOMER'S RIGIDFIX FEMORAL ROD 7MM, RIGIDFIX FEMORAL ROD 8MM, RIGIDFIX FEMORAL ROD 9MM, AND RIGIDFIX FEMORAL ROD 10MM HAD FADED LASER LINES, WHICH CAUSED ISSUES READING THE LETTERING ON THE DEVICES. THE CUSTOMER'S FIRST RIGIDFIX FEMORAL/TIBIAL ROD THUMB SCREW WAS MALLETED INTO THE GUIDE WHEN IT BROKE IN THE GUIDE. THE BREAKAGE HAPPENED OUTSIDE THE PATIENT AND THERE WERE NO FRAGMENTS IN THE PATIENT. THE CUSTOMER'S SECOND RIGIDFIX FEMORAL/TIBIAL ROD THUMB SCREW BENT WHERE THE SCREW MEETS THE THUMB HEAD. THE SCREW BENT WHILE INSERTING INTO THE GUIDE. THE CUSTOMER'S RATCHET HANDLE WITH JACOB'S CHUCK WOULD NOT HOLD THE DRIVER. THE CASE WAS COMPLETED USING THE RIGIDFIX FEMORAL ROD 10MM, THE SECOND RIGIDFIX FEMORAL/TIBIAL ROD THUMB SCREW, AND AN ALTERNATIVE FIXED HANDLE DRIVER. THE SALES REP STATED THAT THERE WAS NO PATIENT HARM OR DELAYS. THE SALES REP COULD NOT PROVIDE LOT NUMBERS FOR ANY OF THE DEVICES. THE DEVICES ARE BEING RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8104597 ↗