RIGIDFIX BIOCRYLRecalls & reported problems across all models

We found 2 models of RIGIDFIX BIOCRYL by Medos International Sàrl in the FDA's device registry (GUDID). Together they are named in 33 adverse event reports in the FDA's MAUDE database, received between Mar 19, 2018 and Jan 13, 2025 — classified as 5 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (16 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported RIGIDFIX BIOCRYL problems

RIGIDFIX BIOCRYL models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• RIGIDFIX BIOCRYL 210815

  FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
  17 reports
• RIGIDFIX BIOCRYL 210816

  FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
  16 reports

Recent RIGIDFIX BIOCRYL adverse event reports

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

• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED THROUGH POST MARKET STUDIES THAT A PATIENT UNDERWENT AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2024 USING A RGDFIX FEM3.3MM ST BR XPIN KIT DEVICE AND INTRAFX ADVBR SCW10X30W/LGSHTH DEVICE ALONG WITH A SPEEDTRAP GRN/WHITE 30MM 4PK DEVICE AND SPEEDTRAP WHITE 30MM 4PK DEVICE. ACCORDING TO THE REPORTER, THE PATIENT REPORTED POST OPERATIVE JOINT STIFFNESS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Tissue Injury

  MAUDE report 21137248 ↗
• MalfunctionNov 27, 2024Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR SURGICAL PROCEDURE, WHEN DRILLING THE SLEEVES FOR RGDFIX FEM3.3MM ST BR XPIN DEVICE IT WAS OBSERVED THAT THE DRILLING TROCAR WOULD BECOME SEIZED IN THE SLEEVE AND WOULD NOT RELEASE. IT WAS REPORTED THAT AFTER THE FIRST DRILL SLEEVE SEIZED, ANOTHER RGDFIX FEM3.3MM ST BR XPIN DEVICE WAS OPENED AND THAT DEVICE SEIZED AS WELL. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A 5-MINUTE DELAY IN THE PROCEDURE DUE TO THE EVENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 2 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20791322 ↗
• MalfunctionNov 26, 2024Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR SURGICAL PROCEDURE, WHEN DRILLING THE SLEEVES FOR RGDFIX FEM3.3MM ST BR XPIN DEVICE IT WAS OBSERVED THAT THE DRILLING TROCAR WOULD BECOME SEIZED IN THE SLEEVE AND WOULD NOT RELEASE. IT WAS REPORTED THAT AFTER THE FIRST DRILL SLEEVE SEIZED, ANOTHER RGDFIX FEM3.3MM ST BR XPIN DEVICE WAS OPENED AND THAT DEVICE SEIZED AS WELL. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A 5-MINUTE DELAY IN THE PROCEDURE DUE TO THE EVENT. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED. THIS IS REPORT 1 OF 2 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20788025 ↗
• MalfunctionJan 8, 2024Migration; Migration

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE ON (B)(6) 2023 THE RGDFIX FEM3.3MM ST BR XPIN KIT DEVICE WHILE BEING USED WITH A SPEEDTRAP WHITE 30MM 4PK AND A SPEEDTRAP GRN/WHITE 30MM 4PK DEVICE THE DEVICE PULLED OUT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 3 FOR (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18464410 ↗
• InjuryJul 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 4 OF 5 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THROUGH CLINICAL RESEARCH THAT A PATIENT UNDERWENT AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH MENISCAL REPAIR PROCEDURE OF THE LEFT KNEE ON (B)(6) 2023 USING A RIGIDFIX BIOCRYL 3.3 MM FEMORAL ST CROSS PIN KIT DEVICE. ACCORDING TO THE REPORT, THE PATIENT HAD A REVISION/REOPERATION PROCEDURE ON (B)(6) 2023 DUE TO AN INFECTION. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Infection

  MAUDE report 17310559 ↗
• MalfunctionMay 23, 2023Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE RIGIDFIX BIOCRYL 2.7 MM BTB CROSS PIN KIT DEVICE WAS DIFFICULT TO MOVE THRU THE GUIDE; AND THAT THE ITEMS SEEMED TO BE MERGED. ANOTHER LIKE 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 16988845 ↗
• MalfunctionDec 9, 2022Break; Break

  IT WAS REPORTED BY SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT ONE OF THE SLEEVES ON THE RIGIDFIX BIOCRYL 2.7 MM BTB CROSS PIN KIT DEVICE BROKE IN HALF AS THE SURGEON WAS INSERTING IT. ACCORDING TO THE REPORT, THE SECOND SLEEVE AND BACKUP BOTH WENT IN WITH NO PROBLEM TO COMPLETE THE PROCEDURE WITH A MINIMAL UNSPECIFIED DELAY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15954709 ↗
• InjuryNov 27, 2022Break; Migration; Break; Migration

  IT WAS REPORTED BY SALES REP THAT POSTOPERATIVELY TO AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE WITH A QUAD AUTOGRAFT PERFORMED ON (B)(6) 2021, THE PATIENT WAS COMPLAINING OF GASTROCNEMIUS PAIN ON (B)(6) 2022, ACCORDING TO THE REPORT, THE DOCTOR GOT AN MRI THAT SHOWED ONE OF THE RIGIDFIX BIOCRYL 3.3 MM FEMORAL ST CROSS PIN KIT DEVICE WAS INSERTED IN SOFT TISSUE AND THE OTHER MAY HAVE BROKEN AND WAS POSTERIOR IN THE KNEE. IT WAS FURTHER REPORTED THAT THE PATIENT HAD JOINT EFFUSION. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 15867156 ↗
• InjuryMay 9, 2022Break; Break

  IT WAS REPORTED BY THE CUSTOMER THAT POSTOPERATIVELY TO AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY PERFORMED ON (B)(6) 2022, THE PATIENT HAD A REVISION SURGERY ON (B)(6) 2022 DUE TO THE BREAKAGE OF THE RGDFIX FEM3.3MM ST BR XPIN KIT DEVICE. THE STATUS OF THE PATIENT POST-REVISION WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14337832 ↗
• MalfunctionMay 4, 2022Mechanical Jam; Mechanical Jam

  THIS IS REPORT 2 OF 3 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE CANNULA SEIZED-UP ON THE INSERTION TROCAR UPON INSERTION OF THE CANNULA AT THE FEMORAL LEVEL THROUGH THE RGDFIX 2.7MM BTB BR XPIN KIT DEVICE. THE EVENT HAPPENED AGAIN WITH TWO LIKE DEVICES. 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 14279499 ↗
• MalfunctionMay 4, 2022Mechanical Jam; Mechanical Jam

  THIS IS REPORT 3 OF 3 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER IN ITALY THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE CANNULA SEIZED-UP ON THE INSERTION TROCAR UPON INSERTION OF THE CANNULA AT THE FEMORAL LEVEL THROUGH THE RGDFIX 2.7MM BTB BR XPIN KIT DEVICE. THE EVENT HAPPENED AGAIN WITH TWO LIKE DEVICES. 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 14279435 ↗
• MalfunctionMay 4, 2022Mechanical Jam; Mechanical Jam

  THIS IS REPORT 1 OF 3 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE CANNULA SEIZED-UP ON THE INSERTION TROCAR UPON INSERTION OF THE CANNULA AT THE FEMORAL LEVEL THROUGH THE RGDFIX 2.7MM BTB BR XPIN KIT DEVICE. THE EVENT HAPPENED AGAIN WITH TWO LIKE DEVICES. 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 14279390 ↗
• MalfunctionSep 17, 2021Product Quality Problem; Product Quality Problem

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE ANCHOR ON THE RGDFIX 2.7MM BTB BR XPIN KIT WAS MISSING UPON OPENING ITS PACKAGE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE SLEEVE AND THE TROCAR WERE JAMMED. ANOTHER LIKE 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 12488171 ↗
• MalfunctionJun 10, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE RIGIDFIX BIOCRYL 3.3 MM FEMORAL ST CROSS PIN KIT DEVICE WAS FUSED ON THE SLEEVE WHILE DOING THE HOLES FOR RIGIDFIX CROSS PIN. 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 11977727 ↗
• MalfunctionAug 15, 2019Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL PROCEDURE THE SHEATH ON THE CUSTOMER'S RIGIDFIX BIOCRYL 2.7 MM BTB CROSS PIN KIT GOT STUCK IN THE TROCAR AND BECAME COLD WELDED. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE WITH NO PATIENT HARM OR SURGICAL DELAY TO THE CASE. THE SALES REP STATED THAT THE DEVICE WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8899492 ↗

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