RIGIDFIX BIOCRYL 210815Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10886705001293), received between Mar 19, 2018 and May 23, 2023 — classified as 1 injury, 16 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (10 reports).

5 other recalls cover devices cleared under the same FDA submission (K090669, K091041, K150209); they may or may not involve this specific model.

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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionMar 14, 2019Break; Break

  IT WAS REPORTED THAT DURING AN ACL RECONSTRUCTION PROCEDURE THE SALES REP'S RIGIDFIX CROSS PIN KIT TROCAR BROKE WHILE DRILLING THE SLEEVE INTO THE LATERAL CONDYLE. THE SALES REP STATED THERE WAS NO PATIENT HARM. IT IS UNKNOWN IF THE CASE WAS COMPLETED SUCCESSFULLY, IF THERE WAS A TIME DELAY, OR IF FRAGMENTS WERE CREATED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8420318 ↗
• MalfunctionJan 18, 2019Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ACL PROCEDURE THE CROSS PIN AND DRILL BIT ON THEIR RIGIDFIX 2.7MM BTB BR CROSS PIN KIT HEATED UP AND MELTED THE TROCAR ON TO THE DRILL BIT. THE SALES REP REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE WITH THE ORIGINAL IMPLANTS FROM THE KIT SAME BONE HOLE BUT OPENED UP ANOTHER KIT FROM A DIFFERENT LOT NUMBER TO USE THE DEVICES. THE SALES REP REPORTED THAT THERE WERE NO PATIENT CONSEQUENCES BUT THERE WAS A THREE MINUTE DELAY IN THE CASE. THE SALES REP STATED THAT THE DEVICE WAS DISCARDED. 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 8261124 ↗
• MalfunctionJan 4, 2019Break; Mechanical Jam; Break; Mechanical Jam

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT TWO RIGID FIX BTB CROSS PIN KITS WERE BEING REVERSED OUT OF THE CANNULA AFTER DRILLING BUT THE DRILL BIT GOT STUCK AND WOULD NOT MOVE OUT OF THE CANNULA. ACCORDING TO THE REPORTER. WHEN THE DOCTOR TRIED TO GET THE DRILL BITS OUT OF THE CANNULAS, BOTH SNAPPED. THERE WAS A FORTY-FIVE MINUTE DELAY. IT WAS UNKNOWN WHAT THE PROCEDURE OUTCOME AND PATIENT STATUS WERE. THE SALES REP COULD NOT PROVIDE ANY ADDITIONAL INFORMATION. THE DEVICES ARE BEING RETURNED FOR EVALUATION. THERE WAS PATIENT INVOLVEMENT REPORTED. 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 Known Impact Or Consequence To Patient

  MAUDE report 8219131 ↗
• MalfunctionJan 4, 2019Break; Mechanical Jam; Break; Mechanical Jam

  THIS IS REPORT 1 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT TWO RIGID FIX BTB CROSS PIN KITS WERE BEING REVERSED OUT OF THE CANNULA AFTER DRILLING BUT THE DRILL BIT GOT STUCK AND WOULD NOT MOVE OUT OF THE CANNULA. ACCORDING TO THE REPORTER. WHEN THE DOCTOR TRIED TO GET THE DRILL BITS OUT OF THE CANNULAS, BOTH SNAPPED. THERE WAS A FORTY-FIVE MINUTE DELAY. IT WAS UNKNOWN WHAT THE PROCEDURE OUTCOME AND PATIENT STATUS WERE. THE SALES REP COULD NOT PROVIDE ANY ADDITIONAL INFORMATION. THE DEVICES ARE BEING RETURNED FOR EVALUATION. THERE WAS PATIENT INVOLVEMENT REPORTED. 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 Known Impact Or Consequence To Patient

  MAUDE report 8219102 ↗
• InjuryAug 16, 2018Break; Break

  IT WAS REPORTED VIA MEDWATCH (MW5078275) THAT DURING A KNEE PROCEDURE, A PORTION OF THE RIGIDFIX BTB CROSS PIN BROKE OFF AND WAS RETAINED IN THE PATIENT'S KNEE WHICH X-RAYS CONFIRMED. THE SURGEON ELECTED TO LEAVE THE PORTION THAT HAD BROKEN OFF VERSUS REMOVING. THIS MEDWATCH WAS RECEIVED BY MITEK REGULATORY VIA MAIL AND THEN GIVEN TO MITEK CUSTOMER QUALITY ON 7-17-2018.

  Patient problems: Foreign Body In Patient

  MAUDE report 7791620 ↗
• MalfunctionAug 10, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE WINGS ON THE CUSTOMER'S RIGIDFIX BIOCRYL BTB 2.7MM CROSS PIN KIT DRILL BIT THAT HOLD THE SHEATH IN PLACE BROKE OFF WHILE DRILLING. THE SALES REP STATED THAT THE DEVICE BROKE OUTSIDE THE PATIENT AND HE CONFIRMED NO DEBRIS IN PATIENT. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES OR DELAYS. 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 7771635 ↗
• MalfunctionJun 12, 2018Separation Failure; Separation Failure

  IT WAS REPORTED BY THE SALES REP VIA EMAIL THE DURING AN ACL PROCEDURE THE TROCAR ON THEIR RIGIDFIX BIOCRYL 2.7 MM BTB CROSS PIN KIT COLD WELDED WITH THE DRILL SLEEVE. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE WITH NO HARM TO THE PATIENT BUT THERE WAS A THREE MINUTE DELAY TO TRY TO PULL APART THE DEVICES AND TO GRAB A NEW DEVICE TO FINISH THE CASE. THE DEVICE WILL BE RETURNING FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7592571 ↗
• MalfunctionApr 30, 2018Mechanical Jam; Mechanical Jam

  BTB RIGID FIX DRILL SLEEVE COLD WELDED ON INSERTER TROCAR X2, ONE TROCAR BROKE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7474019 ↗
• MalfunctionApr 30, 2018Break; Mechanical Jam; Break; Mechanical Jam

  BTB RIGID FIX DRILL SLEEVE COLD WELDED ON INSERTER TROCAR X2, ONE TROCAR BROKE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7474009 ↗
• MalfunctionMar 19, 2018Break; Break

  IT IS REPORTED BY OUR SALES REP THAT DURING THE PROCEDURE, RIGIDFIX SHEATH SNAPPED UPON INSERTION. NEW KIT WAS OPENED AND USED. THERE IS NO PATIENT CONSEQUENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7351294 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K090669, K091041, K150209. One submission often covers many models, so check the product and lot details in each record.

• Z-1678-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212725
• Z-1677-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212724
• Z-1680-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212722
• Z-1681-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212723
• Z-1679-2023 · Apr 13, 2023 · Open, Classified
  DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212726