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HEALIX PEEK ORTHOCORD 222344Recalls & reported problems

Medos International Sàrl · HEALIX PEEK Anchor (1) PEEK Anchor (1) Violet Strand, Size 2 (5 metric) ORTHOCORD braided composite suture, 36 Inches (91cm) (1) Blue Strand, Size 2 (5 metric) ORTHOCORD braided composite suture, 36 Inches (91cm) 3.4mm · Class 2 · Implant

All models of HEALIX PEEK ORTHOCORD (6)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Quick summary

This Healix PEEK bone anchor is used to secure tissue during orthopedic surgery. The 24 reports mostly describe the anchor breaking during surgery, with some reports mentioning it pulling out or the attached suture breaking; replacement devices were used and no patient effects were reported. There were no deaths or injuries, and no recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
24
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10886705023837), received between Jun 1, 2018 and Aug 6, 2024 — classified as 24 malfunctions.

The most frequently reported specific device problem is “Break” (19 reports).

5 other recalls cover devices cleared under the same FDA submission (K102298, 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.

Reports received per month

Nov 2023: 2 reportsDec 2023: 2 reportsJan 2024: 1 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 1 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 1 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break19
  • Fracture2
  • Migration2
  • Device Contaminated During Manufacture or Shipping1

Patient problems

  • No Clinical Signs, Symptoms or Conditions15
  • No Consequences Or Impact To Patient9

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 6, 2024Break; Break

    IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING A REPAIR OF ACHILLES TENDON RUPTURE SURGICAL PROCEDURE ON (B)(6) 2024 THE HEALIX PEEK 3.4MM DEVICE ANCHOR WAS BROKEN. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19919734 ↗
  • MalfunctionMay 20, 2024Break; Break

    ANCHOR BREAKAGE. IT WAS REPORTED THAT DURING THE SURGERY, THE ANCHOR WAS BROKEN OFF (AS THE PHOTO SHOWS), REMOVED ALL THE BROKEN PARTS. 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 19350941 ↗
  • MalfunctionJan 18, 2024Migration; Migration

    IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT THE ANCHOR WAS PULLED OUT. 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 18533759 ↗
  • MalfunctionDec 6, 2023Break; Break

    IT WAS REPORTED BY THE AFFILIATE IN CHINA THAT DURING A HIP SURGICAL PROCEDURE ON (B)(6) 2023 THE HEALIX PEEK 3.4MM DEVICE WHEN THE SUTURE WAS TIGHTENED, THE SUTURE WAS BROKEN OFF. 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.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18274318 ↗
  • MalfunctionDec 1, 2023Break; Break

    IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING AN UNSPECIFIED SURGICAL HIP SURGERY ON 11/18/23 THE HEALIX PEEK 3.4MM DEVICE ANCHOR HAD BROKEN OFF. ALL BROKEN PARTS WERE REMOVED. 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.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18246953 ↗
  • MalfunctionNov 15, 2023Break; Break

    IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A TOTAL HIP REPLACEMENT PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE HEALIX PEEK 3.4MM 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 18140399 ↗
  • MalfunctionNov 14, 2023Break; Break

    IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A TALOFIBULAR LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE HEALIX PEEK 3.4MM 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 18131184 ↗
  • MalfunctionOct 31, 2023Break; Break

    IT WAS REPORTED BY SALES REP IN CHINA THAT DURING A COLLATERAL LIGAMENT OF THE ELBOW JOINT PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE HEALIX PEEK 3.4MM DEVICE BROKE OFF. ALL THE BROKEN PARTS WERE REMOVED. 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 18040813 ↗
  • MalfunctionAug 29, 2023Break; Break

    IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE ANCHOR ON THE HEALIX PEEK 3.4MM (DUAL SUTURE) 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 17645296 ↗
  • MalfunctionApr 10, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

    IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6)2023, IT WAS OBSERVED THAT THERE WAS GLUE AROUND THE SUTURE IN THE JOINT AFTER IMPLANTING HEALIX PEEK 3.4MM (DUAL SUTURE) DEVICE. ACCORDING TO THE REPORT, THE SURGEON USED A SUTURE CUTTER TO REMOVE THE GLUE. 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 16709783 ↗
  • MalfunctionApr 6, 2023Migration; Migration

    IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A LIGAMENT RECONSTRUCTION OF PATELLAR DISLOCATION PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE HEALIX PEEK 3.4MM (DUAL SUTURE) DEVICE PULLED OUT. 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 16691575 ↗
  • MalfunctionMar 29, 2023Break; Break

    IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN ANTERIOR TALOFIBULAR LIGAMENT REPAIR PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE HEALIX PEEK 3.4MM (DUAL SUTURE) DEVICE BROKE OFF. 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 16638277 ↗
  • MalfunctionDec 20, 2022Break; Break

    THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE PACKAGING RIPPED WHEN OPENING THE 4.5 HEALIX ADVANCE PEEK 3-SUTURE ANCHOR W/ ORTHOCORD DEVICE THEN THE ANCHOR GOT CONTAMINATED. IT WAS FURTHER REPORTED THAT A HEALIX PEEK 3.4MM (DUAL SUTURE) DEVICE BROKE. 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 16017428 ↗
  • MalfunctionJun 30, 2022Break; Break

    THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE CUSTOMER IN (B)(6) THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022, IT WAS OBSERVED THAT THE 4.75MM HEALIX ADVANCE KNOTLESS BR ANCHOR DEVICE BROKE. CHANGED INTO ANOTHER ONE TO CONTINUE THE SURGERY BUT THE SAME PROBLEM HAPPENED AGAIN. 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 14877829 ↗
  • MalfunctionJan 26, 2022Break; Break

    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 HEALIX PEEK 3.4MM DEVICE WAS BROKEN OFF. ALL THE BROKEN PARTS WERE REMOVED. 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 13360406 ↗
  • MalfunctionSep 21, 2020Break; Break

    IT WAS REPORTED THAT DURING THE SURGERY OF KNEE ARTHROSCOPY, THE ANCHOR WAS BROKEN OFF, REMOVED ALL THE PIECES. CHANGED ANOTHER ONE, IT HAD THE SAME PROBLEM. 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 10563376 ↗
  • MalfunctionSep 21, 2020Break; Break

    IT WAS REPORTED THAT DURING THE SURGERY OF KNEE ARTHROSCOPY, THE ANCHOR WAS BROKEN OFF, REMOVED ALL THE PIECES. CHANGED ANOTHER ONE, IT HAD THE SAME PROBLEM. 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 10563345 ↗
  • MalfunctionJan 23, 2019Fracture; Fracture

    IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING A ARTHROSCOPIC ROTATOR CUFF REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE HEALIX PEEK 3.4MM DEVICE BROKE AFTER ONE ROUND. ACCORDING TO THE REPORTER, THE EVENT OCCURRED AFTER AWLING WHEN THE SURGEON INSERTED THE DEVICE IN THE BONE HOLE IN THE SAME AXIS. IT WAS NOT REPORTED IF THERE WAS A DELAY IN THE SURGICAL PROCEDURE OR IF A 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 8270953 ↗
  • MalfunctionJan 22, 2019Fracture; Fracture

    IT WAS REPORTED BY THE AFFILIATE IN (B)(6) THAT DURING ARTHROSCOPIC ROTATOR CUFF REPAIR SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE HEALIX PEEK 3.4MM ANCHOR DEVICE BROKE IN THE HOLE IN THE SAME AXIS UPON INSERTION AND AFTER ONE ROUND OF AWLING. ACCORDING TO THE REPORTER, THE AWL/TAP WAS USED TO THE PROPER DEPTH PRIOR TO THE ANCHOR BEING INSERTED. THE SAME BONE HOLE WAS USED FOR THE 2ND ANCHOR. THE PROCEDURE WAS EXTENDED THREE MINUTES DUE TO THE COMPLAINT DEVICE BREAKING. THE ANCHOR BROKE BETWEEN CORTICAL AND SPONGIOUS. THE PATIENT HAD AVERAGE BONE QUALITY. THE ENTIRE COMPLAINT DEVICE WAS REMOVED FROM THE PATIENT. THERE WERE NO ADVERSE 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 8267778 ↗
  • MalfunctionJul 27, 2018Break; Break

    IT WAS REPORTED BY THE SALES REP REPORTED DURING A ROTATOR CUFF PROCEDURE, THE CUSTOMER'S HEALIX PEEK ANCHOR BROKE. THE SALES REP STATED THE PATIENT HAD HARD BONE. THE SURGEON REMOVED THE FRAGMENT, TAPPED FURTHER DOWN AND INSERTED ANOTHER ANCHOR TO COMPLETE THE PROCEDURE.THERE WERE NO PATIENT CONSEQUENCES. THE FACILITY DISCARDED THE DEVICE. IT WAS NOT REPORTED IF THERE WERE ANY 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 7725969 ↗
  • MalfunctionJul 24, 2018Break; Break

    IT WAS REPORTED BY THE SALES REP THAT DURING A ROTATOR CUFF REPAIR THAT THE CUSTOMER'S HEALIX PEEK 3.4MM ANCHOR OF THE HEALIX TRANSTEND PEEK DS WOULD NOT ENGAGE FULLY WHEN BEING INSERTED. THE SALES REP REPORTED THAT WHEN THE ANCHOR WAS BEING INSERTED THE INTERIOR THREAD BECAME STRIPPED AND THE ANCHOR COULD NOT BE DEPLOYED FURTHER INTO THE BONEHOLE. THE SURGEON ATTEMPTED TO REMOVE THE ANCHOR WHEN IT SNAPPED OFF AT THE NOSE LEAVING 1/4 OF THE ANCHOR SECURELY IMPLANTED IN THE BONEHOLE. THE SALES REP CONFIRMED NOTHING WAS LEFT PROUD. THE SURGEON COMPLETED THE PROCEDURE BY IMPLANTING A HEALIX ADVANCE PEEK 4.5 MM ANCHOR ( 222304) NEXT TO THE PARTIAL ANCHOR WITH NO PATIENT CONSEQUENCES. THERE WAS A FIVE MINUTE DELAY IN THE PROCEDURE. THE CUSTOMER ALREADY DISCARDED THE COMPLAINT DEVICE. 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 7715788 ↗
  • MalfunctionJul 16, 2018Break; Break

    THE SALES REP REPORTED THREE OF HIS HEALIX ANCHORS BROKE DURING A ROTATOR CUFF PROCEDURE. THE SURGEON WAS INSERTING A 3.4MM HEALIX BR ANCHOR WITH A TAP WHEN THE DISTAL TIP BROKE. HE REMOVED ALL BROKEN FRAGMENTS AND WENT TO INSERT A HEALIX TRANSTEND ANCHOR INTO THE SAME BONE HOLE AGAIN WITH THE TAP AND THE DISTAL TIP ALSO BROKE UPON INSERTION. THE SURGEON REMOVED THE BROKEN FRAGMENTS AND DECIDES TO INSERT A 3.4MM HEALIX PEEK ANCHOR. THIS ANCHOR STRIPPED OUT WHILE INSERTING AND COULD NOT BE FULLY INSERTED. WHILE THE SURGEON WAS ATTEMPTING TO UNSCREW THIS ANCHOR, IT BROKE INTO PIECES. THE SURGEON REMOVED A FEW FRAGMENTS BUT ENDED UP TAPPING THE REST OF THE BROKEN FRAGMENTS INTO THE BONE. HE THEN WAS ABLE TO SUCCESSFULLY INSERT A HEALIX ADVANCE ANCHOR WITH NO ISSUES. THERE WERE NO PATIENT CONSEQUENCES. THERE WAS A 5 MINUTE DELAY. THIS WAS A (B)(6) MALE PATIENT WITH HARD BONE AND THIS WAS THE SURGEONS FIRST TIME USING HEALIX TRANSTEND. ALL COMPLAINT DEVICES WERE DISCARDED. NO FURTHER INFORMATION WAS AVAILABLE. PLEASE SEE ALSO MEDWATCH REPORT 1221934-2018-53665 AND 1221934-2018-53670.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7690854 ↗
  • MalfunctionJul 5, 2018Break; Break

    IT WAS REPORTED THAT THE DOCTOR USED A 3.4 HEALIX PEEK ANCHOR (REF # (B)(4), LOT # 3686346) IN TANDEM WITH A SINGLE IMPLANT TRANSTEND SYSTEM FOR A PASTA REPAIR. HE DRILLED AND TAPPED ALL THE WAY TO THE LASER LINE FOR BOTH ANCHORS. THE SINGLE LOADED ANCHOR THAT CAME WITH THE TRANSTEND SET WENT IN WITHOUT ANY PROBLEMS. THE FIRST 3.4 HEALIX PEEK ANCHOR STRIPPED APPROXIMATELY THREE QUARTERS OF THE WAY DOWN. THEY DRILLED DOWN ON TOP OF THE ANCHOR AND THEN ATTEMPTED TO SET ANOTHER ANCHOR ON TOP OF IT, WHICH BROKE AS IT WAS BEING SCREWED IN. THEY WERE ABLE TO UNSCREW IT AND REMOVE THE ANCHOR, AND THEN PUT IN THE THIRD AND FINAL ANCHOR, WHICH TOOK AND WAS USED IN THE REPAIR. THE SALES REP CONFIRMED THERE WERE NO PATIENT CONSEQUENCES AND A TEN MINUTE DELAY. BONE QUALITY WAS GOOD NOT HARD. THE SALES REP COULD NOT PROVIDE FURTHER PATIENT INFORMATION.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7664343 ↗
  • MalfunctionJun 1, 2018Break; Break

    IT WAS REPORTED VIA PHONE BY THE SALES REP THAT DURING A ROTATOR CUFF PROCEDURE, HIS HEALIX PEEK ANCHOR SNAPPED IN HALF. THE DOCTOR REMOVED THE BROKEN DEVICE, AND USED ANOTHER LIKE DEVICE IN THE SAME BONE HOLE TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT CONSEQUENCES. THE SALES REP STATED THE INSERTION WAS NOT OFF AXIS, AND THE DEVICE WAS DISCARDED BY THE CUSTOMER.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7560513 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K102298, K150209. One submission often covers many models, so check the product and lot details in each record.

  • 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-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-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-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

Other Screw, fixation, bone devices

All Screw, fixation, bone devices →

Sources and updates

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