RIGIDFIX 213013Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 20886705020000), received between Apr 5, 2018 and May 5, 2026 — classified as 2 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (13 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 5, 2026Break

  THIS IS REPORT 2 OF 3 FOR (B)(4). IT WAS REPORTED THAT DURING A CRUCIATE LIGAMENT OF THE KNEE JOINT PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR ON THE RGDFX CRVE ST ACL PLA XPIN SYS DEVICE BROKE OFF. ALL THE BROKEN PARTS WERE REMOVED. IT WAS FURTHER REPORTED THAT THE SCREW ON THE MILAGRO ADVANCE SCREW 7X30MM DEVICE ALSO BROKE OFF. ALL THE PIECES WERE REMOVED FROM THE PATIENT. A REPLACEMENT DEVICE WAS USED TO CONTINUE THE SURGERY, BUT THE SAME ISSUE OCCURRED AGAIN. THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25085091 ↗
• MalfunctionApr 13, 2026Break; Difficult to Advance

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE PINS ON THE SIDE OF THE DRILL BIT FOR THE FERRULES BROKE OFF FOR (2) RGDFX CRVE ST ACL PLA XPIN SYS DEVICES. IT WAS REPORTED THAT TWO KITS WITH THE SAME LOT NUMBER WERE USED. THE FIRST DRILL BIT WAS COMPLETELY STUCK IN THE FERRULE AND WOULDN'T COME OUT AFTERWARD. WHEN THE DRILL WAS RETRIEVED, THE FERRULE CAME OUT WITH IT. IT TURNED OUT THAT THE PINS HAD BROKEN OFF THE DRILL BIT. THE SECOND KIT USED A NEW FERRULE, WHICH WAS EXTRA WET. THIS ONE WAS DRILLED PROPERLY, AND THE TIPS WERE CHECKED; THEY WERE STILL THERE. WHEN DRILLING THE SECOND FERRULE, IT DIDN'T GO ALL THE WAY IN. IT THEN TURNED OUT THAT THE PINS HAD BROKEN OFF THERE AS WELL. THE REMNANTS OF THE TIPS STILL HAD A LITTLE BIT OF GRIP, BUT THAT QUICKLY DISAPPEARED. THE FERRULE WAS HAMMERED IN THE REST OF THE WAY (THERE WASN'T A THIRD KIT AVAILABLE).THE CROSS PINS WENT IN WITHOUT ANY PROBLEMS, AND THE CRUCIATE LIGAMENT WAS ALSO SECURED PROPERLY. IT WAS FURTHER REPORTED THAT THE KIT BOXES WERE RETAINED, BUT UNFORTUNATELY NOT THE DRILL BITS THEMSELVES. IT WAS REPORTED THAT DUE TO THE EVENT, THE SURGERY WAS PROLONGED BY 15-20 MINUTES. ALL AVAILABLE INFORMATION HA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24858145 ↗
• MalfunctionApr 13, 2026Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, THE PINS ON THE SIDE OF THE DRILL BIT FOR THE FERRULES BROKE OFF FOR (2) RGDFX CRVE ST ACL PLA XPIN SYS DEVICES. IT WAS REPORTED THAT TWO KITS WITH THE SAME LOT NUMBER WERE USED. THE FIRST DRILL BIT WAS COMPLETELY STUCK IN THE FERRULE AND WOULDN'T COME OUT AFTERWARD. WHEN THE DRILL WAS RETRIEVED, THE FERRULE CAME OUT WITH IT. IT TURNED OUT THAT THE PINS HAD BROKEN OFF THE DRILL BIT. THE SECOND KIT USED A NEW FERRULE, WHICH WAS EXTRA WET. THIS ONE WAS DRILLED PROPERLY, AND THE TIPS WERE CHECKED; THEY WERE STILL THERE. WHEN DRILLING THE SECOND FERRULE, IT DIDN'T GO ALL THE WAY IN. IT THEN TURNED OUT THAT THE PINS HAD BROKEN OFF THERE AS WELL. THE REMNANTS OF THE TIPS STILL HAD A LITTLE BIT OF GRIP, BUT THAT QUICKLY DISAPPEARED. THE FERRULE WAS HAMMERED IN THE REST OF THE WAY (THERE WASN'T A THIRD KIT AVAILABLE).THE CROSS PINS WENT IN WITHOUT ANY PROBLEMS, AND THE CRUCIATE LIGAMENT WAS ALSO SECURED PROPERLY. IT WAS FURTHER REPORTED THAT THE KIT BOXES WERE RETAINED, BUT UNFORTUNATELY NOT THE DRILL BITS THEMSELVES. IT WAS REPORTED THAT DUE TO THE EVENT, THE SURGERY WAS PROLONGED BY 15-20 MINUTES. ALL AVAILABLE INFORMATION HA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24858144 ↗
• MalfunctionFeb 5, 2026Break

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE GRYPHON P BR DS ANCHOR W/OC ANCHOR DEVICE, THE RGDFX CRVE ST ACL PLA XPIN SYS DEVICE AND THE MILAGRO ADVANCE SCREW 8X23MM DEVICE WERE BROKEN. IT WAS REPORTED THAT ALL THE BROKEN PARTS WERE REMOVED. SPARE DEVICES WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE EXACT DATE OF THE EVENT WAS NOT REPORTED; HOWEVER, IT WAS REPORTED THAT THE EVENT OCCURRED IN (B)(6) 2025. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 2 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24273572 ↗
• MalfunctionFeb 4, 2026Break

  THIS IS EVENT 4 OF 4 OF (B)(4). IT WAS REPORTED THAT DURING A JOINT SURGICAL PROCEDURE IT WAS OBSERVED THAT 2X MILAGRO ADVANCE SCREW DEVICES AND 2X RIGIDFIX FEM 3.3MM S/T XPIN DEVICES BROKE. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24261196 ↗
• MalfunctionAug 22, 2018Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING ANTERIOR CRUCIATE LIGAMENT (AC) REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE SLEEVE COMPONENTS BROKE OFF DURING DRILLING. THE PROCEDURE WAS COMPLETED WITH SAME LIKE PRODUCT. THERE WAS A DELAY OF 10 MINUTES IN THE SURGICAL PROCEDURE. IT WAS REPORTED THAT NOTHING FELL INTO THE PATIENT. 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 7806248 ↗
• MalfunctionAug 21, 2018Break; Break

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR, IT WAS OBSERVED THAT THE EYEBOLT OF THE DRILL GOT BROKEN TWO TIMES, THE SHEATH GOT STUCK. THE SURGERY WAS FINISHED SUCCESSFULLY WITH AN INTERFERENCE SCREW. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL 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 7801005 ↗
• MalfunctionAug 21, 2018Break; Break

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR, IT WAS OBSERVED THAT THE EYEBOLT OF THE DRILL GOT BROKEN TWO TIMES, THE SHEATH GOT STUCK. THE SURGERY WAS FINISHED SUCCESSFULLY WITH AN INTERFERENCE SCREW. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN A SURGICAL 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 7800999 ↗
• InjuryAug 15, 2018Break; Break

  IT WAS REPORTED THAT AFTER X-RAY INSPECTION THE DOCTOR SEES THAT THERE IS A SMALL PIECE OF METAL IN THE BONE. THE PIECE OF METAL IS FROM THE SLEEVE THAT WAS NECESSARY FOR INSERTION OF THE ANCHOR. LOT NUMBER ISN'T AVAILABLE. THE METAL SLEEVE CLOSES FLUSH WITH THE BONE. THE DOCTOR SEES NO RISK FOR THE PATIENT. NO HARM TO THE PATIENT. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Foreign Body In Patient

  MAUDE report 7786538 ↗
• MalfunctionJul 23, 2018Break; Detachment of Device or Device Component

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) SURGERY, IT WAS OBSERVED THAT THE TROCAR LOCKING PIN BROKE OFF DURING THE DRILLING PHASE. IT WAS REPORTED THAT THE PROCEDURE WAS CARRIED OUT AND FINISHED BY USING A NEW SET. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN 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 7711020 ↗
• MalfunctionJul 23, 2018Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) SURGERY, IT WAS OBSERVED THAT THE SLEEVE COMPONENTS BROKE DURING THE DRILLING PHASE. IT WAS REPORTED THAT THE PROCEDURE WAS CARRIED OUT AND FINISHED BY USING A NEW SET. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. 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 7710486 ↗
• InjuryJul 3, 2018Break; Break

  IT WAS REPORTED BY OUR AFFILIATE THAT, DURING THE REHABILITATION OF A PATIENT A BROKEN RIGIDFIX PIN WAS FOUND. NO FULL KNEE EXTENSION WAS POSSIBLE. THE PIN HAS TO BE REMOVED. INTERVENTION WILL TAKE PLACE AT THE END OF (B)(6) 2018. INITIAL PROCEDURE: (B)(6) 2018. PROCEDURE: ACL REPAIR WITH RIGIDFIX CURVE. PATIENT CONSEQUENCE IS UNKNOWN. ADDITIONAL INFORMATION RECEIVED ON 08/13/18: THERE WAS NO PROBLEM WHEN FITTING THE RIGIDFIX PIN. THE PIN FRACTURED AND FELL IN TO THE PATIENT DURING PROCEDURE. IT WAS RECOVERED DURING THE PROCEDURE AND SENT FOR EVALUATION. THERE WERE COMPLAINTS OF PATELLOFEMORAL SYNDROME AND SIGNIFICANT AMYOTROPHY OF THE QUADRICEPS. THE PATIENT HAD BLOCKAGES RELATED TO THE MOBILIZATION OF A RIGIDFIX PIN FRAGMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 7658035 ↗
• MalfunctionJun 5, 2018Break; Break

  IT WAS REPORTED THAT AFTER THE INSERTION OF THE PIN. THE SURGEON NOTED A LITTLE PIECE OF THE PIN TO BE DETACHED. THE BROKEN PIN WAS REMOVED AND THE INTERVENTION WAS CONCLUDED INSERTING A NEW PIN. NO ADVERSE EVENT FOR THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7570305 ↗
• MalfunctionApr 12, 2018Mechanical Jam; Mechanical Jam

  IT WAS REPORTED THAT WHILE INSERTING THE TROCAR, IT MELTED WITH THE CANULA. NO ADVERSE EVENTS REPORTED.

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

  MAUDE report 7424844 ↗
• MalfunctionApr 5, 2018Mechanical Jam; Mechanical Jam

  IT WAS REPORTED VIA EMAIL THAT THE CUSTOMER'S TROCAR FROM THEIR RIGIDFIX CURVE 3.3MM KIT WELDED WITH THE CANNULA. NO FURTHER DETAILS WERE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7399840 ↗