HEALIX PEEK ORTHOCORD 222207Recalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 10886705007554), received between Jan 7, 2018 and Jun 5, 2024 — classified as 2 injuries, 40 malfunctions.

The most frequently reported specific device problem is “Break” (30 reports).

5 other recalls cover devices cleared under the same FDA submission (K071481, 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 42 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2024Device-Device Incompatibility; Mechanical Jam; Device-Device Incompatibility; Mechanical Jam

  IT WAS REPORTED FROM CHINA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS OBSERVED THAT THE SHAFT ON THE 5.5 HEALIX3 PEEK ANC.W/OCORD DEVICE COULD NOT BE REMOVED AFTER REMOVING THE ANCHOR. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT RESISTANCE WAS FOUND WHEN TRYING TO DISASSEMBLE THE ANCHOR FROM THE SHAFT. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH A DELAY OF 20 MINUTES. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19472449 ↗
• MalfunctionApr 10, 2024Break; Break

  IT WAS REPORTED FROM CHINA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS OBSERVED THAT THE 5.5 HEALIX3 PEEK ANC.W/OCORD DEVICE WAS BROKEN OFF THEN REMOVED ALL THE BROKEN PARTS. THERE WERE NO DELAYS IN THE SURGICAL PROCEDURE AS AN IDENTICAL SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19083906 ↗
• MalfunctionFeb 8, 2024Break; Break

  IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING A ROTATOR CUFF REPAIR SURGICAL PROCEDURE ON (B)(6) 2024 THE 5.5 HEALIX3 PEEK DEVICE ANCHOR HAD BROKEN OFF. ALL PARTS WERE REMOVED. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18668929 ↗
• MalfunctionNov 15, 2023Break; Break

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN ROTATOR CUFF REPAIR PROCEDURE ON 10/1/2023, IT WAS OBSERVED THAT THE ANCHOR ON THE 5.5 HEALIX3 PEEK ANC.W/OCORD DEVICE WAS BROKEN OFF, THEN REMOVED ALL THE BROKEN PARTS. 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 18143264 ↗
• MalfunctionNov 15, 2023Break; Break

  IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON 10/1/2023, IT WAS OBSERVED THAT THE ANCHOR ON THE 5.5 HEALIX3 PEEK ANC.W/OCORD DEVICE WAS BROKEN OFF, THEN REMOVED ALL THE BROKEN PARTS. 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 18143123 ↗
• MalfunctionJan 3, 2023Break; Break

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE SUTURE ON THE 5.5MM HEALIX PEEK 3-SUTURE ANCHOR W/ORTHOCORD DEVICE BROKE OFF. 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 16091140 ↗
• MalfunctionDec 20, 2022Crack; Device Damaged Prior to Use; Crack; Device Damaged Prior to Use

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT PREOPERATIVELY TO A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE ANCHOR ON THE 5.5MM HEALIX PEEK 3-SUTURE ANCHOR W/ORTHOCORD DEVICE WAS BROKEN OFF UPON OPENING ITS PACKAGE. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE ANCHOR HAD A CRACK NEAR THE DISTAL PART. 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 16017713 ↗
• MalfunctionNov 29, 2022Break; Break

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE SUTURE ON THE 55.5MM HEALIX PEEK 3-SUTURE ANCHOR W/ORTHOCORD DEVICE BROKE OFF. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15879961 ↗
• MalfunctionNov 14, 2022Break; Crack; Break; Crack

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE SUTURE ON THE 5.5MM HEALIX PEEK 3-SUTURE ANCHOR W/ORTHOCORD DEVICE WAS CRACKED AND BROKEN OFF. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT NOR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15793983 ↗
• MalfunctionOct 26, 2022Break; Break

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THROUGH THE HEALTH AUTHORITY IN CHINA THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE ANCHOR ON THE 5.5MM HEALIX PEEK 3-SUTURE ANCHOR W/ORTHOCORD BROKE ABOUT 2 TO 3MM. ACCORDING TO THE REPORT, THE SURGEON WAS NOT ABLE TO FIND THE BROKEN PARTS UNDER THE MICROSCOPE AT THE INCISION. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: Foreign Body In Patient

  MAUDE report 15672196 ↗
• MalfunctionJun 30, 2022Detachment of Device or Device Component; Device-Device Incompatibility; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED BY THE CUSTOMER IN CHINA THAT DURING AN ARTHROSCOPIC SHOULDER STABILIZATION PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE ANCHOR AND SHAFT ON THE 5.5MM HEALIX PEEK 3-SUTURE ANCHOR W/ORTHOCORD DEVICE COULD NOT BE DETACHED FROM ONE ANOTHER. DURING IN-HOUSE ENGINEERING EVALUATION, IT WAS DETERMINED THAT THE COVER HANDLE AND THE SHAFT WERE DETACHED FROM THE HANDLE. 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 14880339 ↗
• MalfunctionJan 27, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE ANCHOR COULD NOT BE DETACHED FROM THE SHAFT ON THE 5.5 HEALIX3 PEEK ANC.W/OCORD DEVICE. DURING IN-HOUSE ENGINEERING EVALUATION OF THE PHOTO PROVIDED BY THE CUSTOMER, IT WAS DETERMINED THAT THE SHAFT OF THE DEVICE WAS DETACHED FROM THE HANDLE WHILE THE ANCHOR REMAINED ATTACHED ON THE INSERTER TIP. 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 13367084 ↗
• MalfunctionJan 27, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE ANCHOR COULD NOT BE DETACHED FROM THE SHAFT ON THE 5.5 HEALIX3 PEEK ANC.W/OCORD DEVICE. DURING IN-HOUSE ENGINEERING EVALUATION OF THE PHOTO PROVIDED BY THE CUSTOMER, IT WAS DETERMINED THAT THE SHAFT OF THE DEVICE WAS DETACHED FROM THE HANDLE WHILE THE ANCHOR REMAINED ATTACHED ON THE INSERTER TIP. 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 13367048 ↗
• MalfunctionJan 27, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE ANCHOR COULD NOT BE DETACHED FROM THE SHAFT ON THE 5.5 HEALIX3 PEEK ANC.W/OCORD DEVICE. DURING IN-HOUSE ENGINEERING EVALUATION OF THE PHOTO PROVIDED BY THE CUSTOMER, IT WAS DETERMINED THAT THE SHAFT OF THE DEVICE WAS DETACHED FROM THE HANDLE WHILE THE ANCHOR REMAINED ATTACHED ON THE INSERTER TIP. 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 13367045 ↗
• MalfunctionNov 30, 2021Break; Break

  IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING A SHOULDER REPAIR SURGERY ON (B)(6) 2021, IT WAS OBSERVED THAT THE SUTURE ON THE 5.5 HEALIX3 PEEK ANC.W/OCORD ANCHOR DEVICE WAS PEELED. 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 12897684 ↗
• MalfunctionSep 17, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem

  THIS CASE IS FROM HEALTH AUTHORITY. IT WAS REPORTED THAT THE PHYSICIANS FOUND THE EXPIRE DATE ON THE INNER PACKAGE AND OUTER PACKAGE IS DIFFERENT. IT WAS FOUND THAT THE LABEL ON THE BUILT-IN PACKAGE HAS EXPIRED, WHILE THE OUTER PACKAGE IS WITHIN THE VALIDITY PERIOD. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10549815 ↗
• MalfunctionAug 28, 2020Migration or Expulsion of Device; Migration or Expulsion of Device

  IT WAS REPORTED THAT DURING THE SURGERY OF ROTATOR CUFF SUTURE , WHEN REMOVED THE SHAFT, NOTED THE ANCHOR WAS ALSO PULLED OUT. ANOTHER DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10465166 ↗
• MalfunctionDec 30, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP VIA PHONE THAT DURING A ROTATOR CUFF REPAIR PROCEDURE THE TIP OF THEIR 5.5 HEALIX 3 PEEK ANCHOR WITH ORTHOCORD BROKE DURING INSERTION. THE TIP WAS PULLED OUT AND DEBRIS WAS LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE DEVICE USING THE SAME BONE HOLE WITH NO PATIENT HARM OR SURGICAL DELAY TO THE CASE. THE PATIENT'S BONE QUALITY WAS AVERAGE. THE DEVICE WAS DISCARDED BY THE CUSTOMER.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 9531927 ↗
• MalfunctionDec 26, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP VIA CST TOOL THAT THE DOCTOR WENT TO INSERT THE 5.5 HEALIX 3 PEEK ANCHOR WITH ORTHOCORD AND THE TIP BROKE OFF INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER ANCHOR WITH NO PATIENT CONSEQUENCES OR SURGICAL DELAY TO THE CASE. FRAGMENTS WERE GENERATED. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED VIA PHONE ON (B)(6) 2019: THE SALES REP STATED THAT THE CASE WAS A ROTATOR CUFF REPAIR. THERE WAS NO DEBRIS LEFT IN THE PATIENT, THE DOCTOR JUST REMOVED THE BROKEN TIP WITH NO ISSUES. THE SAME BONE HOLE WAS USED TO COMPLETE THE PROCEDURE. THE PATIENT'S BONE QUALITY WAS AVERAGE. THE SALES REP STATED THAT THE DEVICE WAS DISCARDED BY THE CUSTOMER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9522085 ↗
• InjuryMay 30, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED BY THE SALES REP VIA CST THAT DURING AN ARTHROSCOPIC ROTATOR CUFF REPAIR SURGICAL PROCEDURE AFTER THE 5.5 HEALIX PEEK THREE-SUTURE ANCHOR WITH ORTHOCORD WAS INSERTED INTO THE PATIENT, THE INSERTER WAS PULLED OUT AND A SUTURE SNAPPED. FRAGMENTS WERE GENERATED AND REMOVED WITHOUT ADDITIONAL INTERVENTION. THE CASE WAS COMPLETED WITH A KNOTLESS ANCHOR WITH NO PATIENT HARM, BUT A FIVE MINUTE SURGICAL DELAY TO OPEN THE NEW ANCHOR. IT WAS REPORTED THAT THE ANCHOR WAS LEFT IN THE PATIENT. THE CASE WAS COMPLETED BY CREATING A NEW BONE HOLE AND USING THE KNOTLESS ANCHOR. IT WAS REPORTED THAT THE SUTURE WAS COLORED BIG BLUE CHECK. IT WAS REPORTED THAT THE SUTURE BROKE AT THE VERY MIDDLE OF SUTURE JUST UNDER THE ANCHOR BRIDGE. IT WAS REPORTED THAT A SUTURE PASSER WAS USED IN THE PROCEDURE. IT WAS REPORTED THAT THE SURGEON USED PROPER SUTURE MANAGEMENT. THERE WAS PATIENT INVOLVEMENT. 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 WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Foreign Body In Patient; Injury; No Code Available; Not Applicable

  MAUDE report 8654041 ↗
• MalfunctionJan 29, 2019Material Frayed; Material Frayed

  IT WAS REPORTED BY THE AFFILIATE IN (B)(4) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE 5.5 HEALIX 3 PEEK "ANC.W/OCORD" SUTURE DEVICE BROKE WHILE DOING THE KNOT. 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 8286541 ↗
• MalfunctionJan 17, 2019Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE OF THE SHOULDER, IT WAS OBSERVED THAT THE DISTAL TIP ON THE IMPLANTED 5.5 HEALIX3 PEEK ANC.W/OCORD ANCHOR DEVICE BROKE UPON INSERTION. IT WAS REPORTED THAT THE SURGEON PULLED THE ANCHOR OUT, TAPPED AND OPENED A SPARE DEVICE TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THE ORIGINAL BONE HOLE WAS USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THE SURGEON WAS NOT OFF AXIS. IT WAS REPORTED THAT THE PATIENT HAD A HARD BONE. 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 8257061 ↗
• MalfunctionJan 11, 2019Break; Break

  THIS IS REPORT 2 OF 3 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING ROTATOR CUFF NEOPLASTY, IT WAS OBSERVED THAT TWO SCREWS WERE DAMAGED AND ONE WAS BROKEN. THE BROKEN PIECE DIDN'T FALL INTO PATIENT. IT WAS REPORTED THAT THE SURGEON CHANGED THE NEW REPLACEMENTS TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE EVENT OR EXTENDED SURGERY. 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 8241655 ↗
• MalfunctionJan 11, 2019Break; Break

  THIS IS REPORT 1 OF 3 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING ROTATOR CUFF NEOPLASTY, IT WAS OBSERVED THAT TWO SCREWS WERE DAMAGED AND ONE WAS BROKEN. THE BROKEN PIECE DIDN'T FALL INTO PATIENT. IT WAS REPORTED THAT THE SURGEON CHANGED THE NEW REPLACEMENTS TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE EVENT OR EXTENDED SURGERY. 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 8241320 ↗
• MalfunctionJan 11, 2019Break; Break

  THIS IS REPORT 3 OF 3 FOR THE SAME EVENT. IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING ROTATOR CUFF NEOPLASTY, IT WAS OBSERVED THAT TWO SCREWS WERE DAMAGED AND ONE WAS BROKEN. THE BROKEN PIECE DIDN'T FALL INTO PATIENT. IT WAS REPORTED THAT THE SURGEON CHANGED THE NEW REPLACEMENTS TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE EVENT OR EXTENDED SURGERY. 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 8241285 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071481, 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-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-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