RIGIDFIX BIOCRYL 210816Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10886705001309), received between Jul 31, 2018 and Jan 13, 2025 — classified as 4 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 16 most recent of 16 reports, 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionApr 2, 2019Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE AFFILIATE VIA CST THAT DURING AN ACL REPAIR THEY WERE UNABLE TO REMOVE THE TROCAR FROM THE SLEEVE DURING DRILLING. THE PROCEDURE WAS COMPLETED BY CHANGING TO ANOTHER SET OF RIGIDFIX CROSS PINS WITH A 3 MINUTE TIME DELAY. THE AFFILIATE REPORTED THAT THERE WAS NO PATIENT HARM.

  Patient problems: Not Applicable

  MAUDE report 8473550 ↗
• MalfunctionJan 25, 2019Fracture; Fracture

  THE SALES REP REPORTED VIA PHONE THAT WHEN DRILLING THE SLEEVE THE WINGS BROKE OFF THE TROCAR ON THE CUSTOMER'S RIGIDFIX 3MM ST BR CROSS PIN KIT DURING AN ANTERIOR CRUCIATE LIGAMENT SURGICAL PROCEDURE. THE DEVICE BROKE OUTSIDE OF THE PATIENT AS THE GUIDE IS USED ON THE OUTSIDE. THE CASE WAS COMPLETED WITH ANOTHER LIKE DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES WITH A 5-MINUTE DELAY. THE SALES REP STATED THE DEVICE WAS DISCARDED BY THE CUSTOMER. 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 8277793 ↗
• MalfunctionJan 21, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT ACL SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE WINGS ON THEIR RIGIDFIX BCRYL 3.3MM FEMORAL ST TROCAR BROKE OFF OUTSIDE THE PATIENT. THE SALES REP STATED THAT NOTHING FELL IN THE PATIENT. THE SALES REP ALSO REPORTED THAT DURING THE SAME CASE THEIR RIGIDLOOP ADJUSTABLE CORTICAL IMPLANT STANDARD (FIRST TIME USED AT THE FACILITY) THE IMPLANT WAS INTROVERTLY PULLED OFF THE CARD BEFORE IMPLANTING INTO THE PATIENT. THE SALES REP REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE WITH OTHER LIKE DEVICES USING THE SAME BONE HOLE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP STATED THAT BOTH DEVICES WERE 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 8265336 ↗
• MalfunctionJan 21, 2019Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT ACL SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE TROCAR AND SLEEVE ON THEIR RIGID FIX 3MM FEMORAL ST BR CROSS PIN KIT COLD WELDED TOGETHER AND COULD NOT BE USED. THE SALES REP REPORTED THAT THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE USING THE SAME BONE HOLE WITH NO PATIENT CONSEQUENCES OR DELAYS. THE SALES REP STATED THAT NOTHING BROKE OR FELL IN THE PATIENT. 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 8265188 ↗
• MalfunctionNov 15, 2018Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL RECONSTRUCTION PROCEDURE, IT WAS OBSERVED THAT THE RIGIDFIX 3.3MM FEMORAL CROSS PIN KIT DRILL BIT DEVICE THAT GOES THROUGH THE CANNULATED PORTION OF THE DEVICE COLD-WELDED TOGETHER. THE SALES REP STATED THAT DUE TO THIS THE GUIDE WOULD NOT STAY IN THE PATIENT. THE CASE WAS COMPLETED WITH ANOTHER LIKE-DEVICE WITH NO PATIENT HARM OR DELAY. THE DEVICE WAS DISCARDED BY THE CUSTOMER. 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 8074983 ↗
• MalfunctionNov 6, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL RECONSTRUCTION PROCEDURE THE SALES REP'S RIGIDFIX 3.3MM FEMORAL CROSS PIN KIT SHEATH BROKE WHILE ATTEMPTING TO REMOVE FROM THE PATIENT. THE SALES REP STATED THAT WHILE INSERTING THE IMPLANT, THE WIRE ARMS SNAPPED OFF WHILE IT WAS BEING DRILLED IN AND THE PROXIMAL END OF THE SHEATH SEPARATED FROM THE DISTAL END. THE SALES REP STATED THAT THE PATIENT HAD HARD BONE. THE SALES REP STATED THAT THE REMAINDER OF THE SHEATH WAS LEFT IN THE PATIENT AND THAT IS HOW THE CASE WAS COMPLETED. THEY TOOK AN X-RAY AND CHOSE TO LEAVE IT IN. THE SALES REP STATED THERE IS NO PLAN FOR SURGICAL INTERVENTION. THERE WAS A FIFTEEN MINUTE DELAY TO REMOVE THE PROXIMAL END OF THE SHEATH AND END THE SURGERY. THE DEVICE IS NOT RETURNING AS IT IS IMPLANTED IN 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: Not Applicable

  MAUDE report 8043730 ↗
• MalfunctionAug 23, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE TROCAR PIN ON THE RIGIDFIX BIOCRYL FEMORAL 3.3MM ST CROSS PIN KIT DEVICE BROKE WHEN THE SURGEON STARTED DRILLING THE SLEEVE. IT WAS REPORTED THAT NOTHING FELL INTO THE PATIENT. THEY OPENED ANOTHER KIT TO COMPLETE THE PROCEDURE. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE 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 7810097 ↗
• MalfunctionJul 31, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) SURGICAL PROCEDURE WHEN THE SURGEON WAS DRILLING THE SLEEVE, THE TWO PRONGS ON THE TROCAR LOCKING PIN BROKE. THEY OPENED ANOTHER KIT TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS IN THE 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 7736534 ↗

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-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
• 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-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-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-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