RIGIDFIX 210127Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 10886705000883), received between Apr 17, 2018 and Jul 15, 2025 — classified as 11 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Break” (15 reports).

5 other recalls cover devices cleared under the same FDA submission (K013781, K150209, K974291); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2025Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, IT WAS OBSERVED THAT THE RIGIDFIX FEM2.7MM B/T/B XPIN DEVICE SLEEVE ASSEMBLY WAS BROKEN WHILE IN USE. ACCORDING TO THE REPORTER THE PIN WAS EMBEDDED, DIFFICULT TO REMOVE AND APPROXIMATELY 1.5 CM OF METAL WAS LEFT IN SITU. IT WAS REPORTED THAT THE PIN WAS EMBEDDED AND THERE SHOULD NOT BE ANY PROBLEMS WITH IT. THERE WAS NO DELAY IN THE PROCEDURE REPORTED. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22506423 ↗
• MalfunctionJul 2, 2025Break; Break

  IT WAS REPORTED THAT DURING AN ANTERIOR CRUCIATE LIGAMENT BONE-TENDON-BONE RECONSTRUCTION PROCEDURE, THE SLEEVE ASSEMBLY INCLUDED IN THE RIGIDFIX FEM2.7MM B/T/B XPIN DEVICE BROKE. THE REPORTER STATED THAT THE SLEEVE ASSEMBLY INCLUDED IN THE RIGIDFIX FEM2.7MM B/T/B XPIN DEVICE KIT WAS UTILIZED AS A GUIDE FOR THE PROPER PLACEMENT OF THE RIGIDFIX PIN TO SECURE THE GRAFT. AFTER DRILLING, THE SLEEVE ASSEMBLY WAS INTENDED TO BE REMOVED AND DISCARDED. HOWEVER, DURING THE REMOVAL OF ONE SLEEVE ASSEMBLY, IT SNAPPED, LEAVING APPROXIMATELY 1.5 CM OF METAL RETAINED IN THE SITE. THE SURGEON ATTEMPTED TO RETRIEVE THE BROKEN PIECE BUT COULD NOT SUCCEED DUE TO LIMITED ACCESS. IT WAS REPORTED THAT THE RETAINED METAL FRAGMENT DID NOT IMPACT ON THE MOBILITY OF THE JOINT OR THE POSITIONING OF THE GRAFT. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: Foreign Body In Patient

  MAUDE report 22383513 ↗
• MalfunctionDec 8, 2023Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTION PROCEDURE PERFORMED ON (B)(6) 2023 IT WAS OBSERVED THAT THE CANNULATED DRILL WAS GETTING CAUGHT IN THE SLEEVE OF BOTH RIGIDFIX FEM2.7MM B/T/B XPIN DEVICES USED IN THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES. THERE WAS NO SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18297096 ↗
• MalfunctionDec 8, 2023Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT (ACL) RECONSTRUCTION PROCEDURE PERFORMED ON (B)(6) 2023 IT WAS OBSERVED THAT THE CANNULATED DRILL WAS GETTING CAUGHT IN THE SLEEVE OF BOTH RIGIDFIX FEM2.7MM B/T/B XPIN DEVICES USED IN THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES. THERE WAS NO SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 2 FOR THE SAME EVENT IN (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18297025 ↗
• InjuryJul 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 9 OF 10 FOR (B)(4). IT WAS REPORTED THROUGH A REVIEW OF NEW ZEALAND ACL REGISTRY DEPUY IMPLANT REPORT RECEIVED AS PER IIS (DPS_JMP_2018_067) CONTRACT MILESTONE DELIVERABLE THAT POSTOPERATIVELY TO AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE RIGIDFIX PLA 2.7 MM BTB CROSS PIN KIT DEVICE FAILED THAT REQUIRED A REVISION SURGERY. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 17309060 ↗
• MalfunctionApr 21, 2023Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE DRILL PIT WELDED TOGETHER WITH THE RIGIDFIX PLA 2.7 MM BTB CROSS PIN KIT DEVICE. 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 16791521 ↗
• MalfunctionNov 1, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN NEW ZEALAND THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE RIGIDFIX PLA 2.7 MM BTB CROSS PIN KIT DEVICE JAMMED IN THE SLEEVE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES NOR SURGICAL DELAY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15710691 ↗
• InjuryOct 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS REPORT 6 OF 10 FOR PC-(B)(4). THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL RESEARCH REPORT FROM NEW ZEALAND FOR CLINICAL EVIDENCE ON SAFETY AND PERFORMANCE OF A RIGIDFIX PLA 2.7 MM BTB CROSS PIN KIT DEVICE WHERE A PATIENT REQUIRED RE-OPERATION 547 DAYS AFTER AN INITIAL ARTHROSCOPIC KNEE PROCEDURE FOR THE REMOVAL OF THE IMPLANTS DUE TO IMPLANT DISCOMFORT. THE CURRENT STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15685397 ↗
• InjuryJul 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A REVIEW OF NEW ZEALAND ACL REGISTRY DEPUY IMPLANT REPORT RECEIVED AS PER IIS (DPS_JMP_2018_067) CONTRACT MILESTONE DELIVERABLE THAT POSTOPERATIVELY TO AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE ON AN UNKNOWN DATE, IT WAS OBSERVED THAT THE RIGIDFIX PLA 2.7 MM BTB CROSS PIN KIT DEVICE FAILED THAT REQUIRED A REVISION SURGERY. THE STATUS OF THE PATIENT WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14991426 ↗
• MalfunctionJul 6, 2022Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE AFFILIATE IN FRANCE THAT THE RIGIDFIX PLA 2.7 MM BTB CROSS PIN KIT DEVICE GOT JAMMED IN THE CANNULA. 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 14939934 ↗
• MalfunctionAug 20, 2021Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNKNOWN PROCEDURE PM (B)(6) 2021, IT WAS OBSERVED THAT THE RIGIDFIX PLA 2.7 MM BTB CROSS PIN KIT DEVICE WAS STUCK. 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 12351015 ↗
• MalfunctionMay 3, 2021Use of Device Problem; Use of Device Problem

  IT WAS REPORTED BY THE SALES REP IN (B)(6) THAT DURING AN ANTERIOR CRUCIATE LIGAMENT PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE RIGIDFIX FEM2.7MM B/T/B XPIN DEVICE HAD AN UNSPECIFIED MALFUNCTION. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE SLEEVE AND THE TROCAR WERE FOUND JAMMED ON THE DEVICE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11764295 ↗
• MalfunctionDec 8, 2020Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE THE COLD WELD OF THE DRILL SLEEVE FROM THE RIGIDFIX PLA 2.7 MM BTB CROSS PIN KIT DEVICE ENDED UP WELDED IN THE TROCAR. ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. THE DEVICE WAS DISCARDED BY THE STAFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10970128 ↗
• InjuryAug 7, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE VIA CST THAT AFTER THE RIGIDFIX FEM2.7MM BEING INSERTED, THE RIGIDFIX BTB CROSS PIN SLEEVE WAS REMOVED BY USING THE SLEEVE REMOVAL TOOL. THE SURGEON REALIZED THAT THERE WAS A PIECE MISSING WHEN THE CROSS PIN SLEEVE WAS PULLED OUT - IT REMAINED IN THE BONE. BY USING RADIOGRAPHY, THIS PIECE WAS IDENTIFIED, BUT NOT REMOVED. THE CASE WAS COMPLETED BY USING A MILAGRO ADVANCE SCREW TO FIX THE TRANSPLANT IN THE FEMORAL TUNNEL. NO DELAY REPORTED. THE DEVICE WAS DISCARDED ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE REPORTING THE DEVICE WILL NOT BE RETURNING FOR EVALUATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 8871796 ↗
• MalfunctionJun 18, 2019Mechanical Jam; Mechanical Jam

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL RECONSTRUCTION PROCEDURE THE 2.7 MM RIGIDFIX CROSS PIN KIT TROCAR AND DRILL SLEEVE COLD-WELDED TOGETHER. THE SALES REP STATED THAT THE ISSUE WAS NOTICED AFTER DRILLING INTO THE PATIENT AND WHILE PULLING THE TROCAR OUT. THE CASE WAS COMPLETED WITH ANOTHER KIT WITHOUT PATIENT HARM OR DELAY. THE KIT IS BEING RETURNED FOR EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8707719 ↗
• InjuryFeb 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE AFFILIATE VIA EMAIL THAT A REPORT RECEIVED FOR IIS (INVESTIGATOR INITIATED STUDIES) WHICH IS AN ACL REGISTRY IN (B)(6) WAS UPLOADED. THE REGISTRY GOAL IS TO CAPTURE ALL ACL PROCEDURES PERFORMED IN (B)(6) AND CURRENTLY HAVE 117 PARTICIPATING SURGEONS. ALL DATA PROVIDED FROM PARTICIPATING SURGEONS IS DE-IDENTIFIED AND CAPTURES ALL PROCEDURES/DEVICES ACROSS ALL INDUSTRY MANUFACTURERS. ON OPENING THE REPORT TO REVIEW THE INFORMATION, AFFILIATE IDENTIFIED THE IMPLANT COMPLICATION RATES FOR ALL DEPUY PRODUCTS CURRENTLY CAPTURED IN THE REGISTRY ON THE LAST PAGE OF THE REPORT. ON DISCUSSION WITH MEDICAL DIRECTOR, THE INFORMATION IS BEING PROVIDED BY THE AFFILIATE TO THE PRODUCT SAFETY FOR ENTRY INTO THE COMPLAINTS SYSTEM AS ¿INFORMATION ONLY¿ GIVEN THE DATA IS CUMULATIVE OVER THE DURATION OF THE REGISTRY; NO FURTHER INFORMATION IS AVAILABLE. THERE IS THE POTENTIAL OF DUPLICATIVE REPORTING IF ANY OF THESE CASES HAVE ALREADY BEEN INDIVIDUALLY (REPORTED TO THE COMPANY) AT THE POINT OF OCCURRENCE (FROM EITHER SURGEON/EMPLOYEE CLINICAL SPECIALIST) AS STATED BY THE AFFILIATE. THE REPORT STATES THAT 5 RIGIDFIX FEM2.7MM B/T/B XPIN; PRODUCT CODE 210127, FAILED DUE TO UNKNOWN

  Patient problems: No Code Available

  MAUDE report 8376375 ↗
• MalfunctionJan 25, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE OF THE KNEE, IT WAS OBSERVED THAT THE EXTERNAL TIP ON THE RIGIDFIX FEM2.7MM B/T/B XPIN DEVICE BROKE WHEN REMOVING ONE OF THE TWO SLEEVES AFTER THE PLACEMENT OF THE PINS. ACCORDING TO THE REPORTER, THE EVENT PREVENTED THE REMOVAL OF THE SLEEVE WITH THE CLAMP PROVIDED. IT WAS REPORTED THAT THE SURGEON HAD TO USE ANOTHER CLAMP. THERE WERE NO PATIENT CONSEQUENCES. THERE WAS NO NEED TO USE ANOTHER KIT. IT WAS REPORTED THAT DURING PLACING, THE SURGEON HAD TO FORCE ABNORMALLY ON THE SLEEVE AND HE HAD DIFFICULTY TO PLACE AND REMOVE THE INTERLOCKING TROCAR. THERE WAS A DELAY OF FIVE MINUTES IN THE SURGERY. IT WAS REPORTED THAT THE TIP OF THE SLEEVE DID NOT FALL 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 8277826 ↗
• MalfunctionJan 24, 2019Break; Break

  IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT PRIOR TO AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE RIGIDFIX FEM2.7MM B/T/B XPIN DEVICE WAS FOUND TO BE BROKEN WHEN IT WAS REMOVED FROM THE PACKAGING. THERE WAS NO DELAY IN THE SURGICAL PROCEDURE AS AN IDENTICAL SPARE DEVICE WAS USED TO COMPLETE 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 8275315 ↗
• InjuryDec 11, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING AN ACL RECONSTRUCTION PROCEDURE THE CUSTOMER'S RIGIDFIX CROSS PIN KIT METAL SLEEVE BROKE OFF IN THE PATIENT WHILE IT WAS BEING REMOVED. THE SALES REP STATED THAT THE CROSS PINS TRAVEL THROUGH THE METAL SLEEVES INTO THE FEMUR. THE SALES REP STATED THAT THE PATIENT HAD HARD BONE AND THERE WAS EXCESSIVE FORCE BEING USED WHILE THE DEVICE WAS REMOVED. THE BREAKAGE OCCURRED AT THE END OF THE CASE, SO THE PROCEDURE WAS COMPLETED WITH THIS DEVICE WITH NO DELAY. THE SURGEON DID NOT REMOVE THE METAL PIECE FROM THE PATIENT, WHICH THE SALES REP STATED IS NO LARGER THAN THREE CENTIMETERS. THERE IS NO SURGICAL INTERVENTION PLANNED. THE DEVICE WAS DISCARDED BY THE CUSTOMER. THERE WAS PATIENT INVOLVEMENT REPORTED. THE STATUS OF THE PATIENT POST-SURGERY WAS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 8150427 ↗
• MalfunctionAug 8, 2018Break; Break

  THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. IT WAS REPORTED BY THE CUSTOMER THAT DURING ANTERIOR CRUCIATE LIGAMENT (ACL) REPAIR, IT WAS OBSERVED THAT THE SURGEON BROKE THE SLEEVE AND THE RIGIDFIX CROSS PIN WHILE IN USE TOGETHER OUTSIDE THE PATIENT DUE TO EXCESSIVE FORCE WITH THE PATIENT BEING A YOUNGER FEMALE WITH HARD BONE MATTER. IT WAS REPORTED THAT THE SURGEON USED EXCESSIVE FORCE, AS THE PATIENT WAS A YOUNG FEMALE WITH HARD BONES. THE SURGEON USED ANOTHER LIKE KIT TO COMPLETE THE PROCEDURE WITH A 10 MINUTE DELAY AND NO PATIENT CONSEQUENCES. 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 7761528 ↗
• MalfunctionJul 19, 2018Break; Break

  IT WAS REPORTED THAT THERE WAS A SLEEVE BREAKAGE DURING THE TIPS INSERTION FOR 2 KITS OF THE SAME LOT. NO CONSEQUENCES TO THE PATIENT - ANOTHER LIKE DEVICE WAS USED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7701546 ↗
• MalfunctionJul 19, 2018Break; Break

  IT WAS REPORTED THAT THERE WAS A SLEEVE BREAKAGE DURING THE TIPS INSERTION FOR 2 KITS OF THE SAME LOT. NO CONSEQUENCES TO THE PATIENT - ANOTHER LIKE DEVICE WAS USED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7701543 ↗
• MalfunctionJun 15, 2018Break; Break

  CUSTOMER REPORTS THE SLEEVE BROKE WHEN SURGEON WAS DRILLING. SURGEON REPORTS THAT HE FOLLOWED THE NORMAL PROCEDURE, AND HE DIDN'T APPLY ANY PARTICULAR FORCE ON THE DEVICE, SO HE SUSPECTS THE METAL WAS TOO WEAK. A NEW SLEEVE WAS TAKEN FROM ANOTHER BOX IN ORDER TO CARRY OUT THIS PROCEDURE. NO ADVERSE REACTION ON PATIENT CAME OUT. ADDITIONAL INFORMATION RECEIVED FROM OUR AFFILIATE ON MAY 06, 2013 INDICATES THAT NOTHING FELL INTO THE PATIENT, AND THE PROCEDURE WAS EXTENDED FOR TEN (10) MINUTES DUE TO THE PROBLEM WITH THE COMPLAINT DEVICE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7605482 ↗
• InjuryMay 18, 2018Break; Break

  THE AFFILIATE REPORTED VIA EMAIL THE SHEATH SHEARED OFF DURING SURGERY. APPROX 1 CM HAD TO BE LEFT IN THE PATIENT. THE REMAINING PORTION OF THE DEVICE WAS DISCARDED. ADDITIONAL INFORMATION RECEIVED FROM AFFILIATE 5/16/18: WHAT WAS THE SURGEON DOING WHEN THE SHEATH BROKE ( DO YOU MEAN EITHER THE TROCAR OR SLEEVE)? TROCAR. HE WAS TRYING TO REMOVE IT FROM THE LATERAL FEMUR WITH THE REMOVAL TOOL. IS THE SHEATH CONTAINED OR SITTING PROUD? SITTING PROUD OFF THE BONE (1CM OF TROCAR) ¿DID THE BREAKAGE RESULT IN SURGICAL DELAY OF GREATER THAN 30 MINUTES OR AN INABILITY TO COMPLETE THE PROCEDURE AS INTENDED? NO. HOW WAS THE PROCEDURE COMPLETED? SURGEON LEFT TROCAR IN PATIENT, THINKING THAT THE POTENTIAL DAMAGE IS LESS THAN POTENTIAL DAMAGE TO FEMUR IN TRYING TO RETRIEVE IT FURTHER. WERE ALTERNATIVES READILY AVAILABLE?N/A . DOES THE SURGEON PLAN ON REMOVING THIS FRAGMENT AT A LATER TIME? NOT AT PRESENT. ANY PATIENT IMPACT? NOT AT PRESENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 7528256 ↗
• InjuryMay 18, 2018Break; Break

  THE AFFILIATE REPORTED VIA EMAIL THE SHEATH SHEARED OFF DURING SURGERY. APPROX 1 CM HAD TO BE LEFT IN THE PATIENT. THE REMAINING PORTION OF THE DEVICE WAS DISCARDED. ADDITIONAL INFORMATION RECEIVED FROM AFFILIATE 5/16/18: WHAT WAS THE SURGEON DOING WHEN THE SHEATH BROKE ( DO YOU MEAN EITHER THE TROCAR OR SLEEVE)? TROCAR. HE WAS TRYING TO REMOVE IT FROM THE LATERAL FEMUR WITH THE REMOVAL TOOL. IS THE SHEATH CONTAINED OR SITTING PROUD? SITTING PROUD OFF THE BONE (1CM OF TROCAR). DID THE BREAKAGE RESULT IN SURGICAL DELAY OF GREATER THAN 30 MINUTES OR AN INABILITY TO COMPLETE THE PROCEDURE AS INTENDED? NO. HOW WAS THE PROCEDURE COMPLETED? SURGEON LEFT TROCAR IN PATIENT, THINKING THAT THE POTENTIAL DAMAGE IS LESS THAN POTENTIAL DAMAGE TO FEMUR IN TRYING TO RETRIEVE IT FURTHER. WERE ALTERNATIVES READILY AVAILABLE? N/A. DOES THE SURGEON PLAN ON REMOVING THIS FRAGMENT AT A LATER TIME? NOT AT PRESENT. ANY PATIENT IMPACT? NOT AT PRESENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 7527280 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K013781, K150209, K974291. 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