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
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, ClassifiedDePuy 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, ClassifiedDePuy 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, ClassifiedDePuy 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, ClassifiedDePuy 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, ClassifiedDePuy 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
- NA 03.043.029Synthes GmbH · Screw, fixation, bone503 reports
- OSTEORAPTOR 72201995Smith & Nephew, Inc. · Screw, fixation, bone253 reports
- Control 360 SK12Treace Medical Concepts, Inc. · Screw, Fixation, Bone195 reports
- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-225Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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