GRYPHON ORTHOCORD 210030Recalls & reported problems
Medos International Sàrl · GRYPHON PEEK DS Anchor w/ORTHOCORD PEEK Anchor, (1) Violet (1) Blue Strand, Size 2 (5 metric) ORTHOCORD braided composite suture, 36 Inches (91cm) · Class 2 · Implant
All models of GRYPHON ORTHOCORD (6)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Medos GRYPHON PEEK DS anchor with Orthocord suture is a bone fixation anchor used in shoulder, hip, knee, ankle and labral repair surgery. Reports mostly describe the anchor breaking off during surgery, with the suture detaching or the anchor pulling out of the bone, so fragments had to be removed and a spare device used to finish the operation. There are 37 reports, no deaths and 1 injury. 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
- 37
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10886705019939), received between Aug 30, 2013 and Jul 30, 2025 — classified as 1 injury, 36 malfunctions.
The most frequently reported specific device problem is “Break” (28 reports).
5 other recalls cover devices cleared under the same FDA submission (K103712, 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
- Break28
- Migration2
- Adverse Event Without Identified Device or Use Problem1
- Delivered as Unsterile Product1
- Detachment of Device or Device Component1
- Loss of or Failure to Bond1
- Material Split, Cut or Torn1
- Packaging Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions28
- No Consequences Or Impact To Patient8
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Osteolysis1
Recent adverse event reports
The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 30, 2025Break; Break
THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT DURING A ROTATOR CUFF REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR ON THE 4.5 HEALIX ADVANCE BR W/OCORD DEVICE BROKE OFF. ALL THE BROKEN PARTS WERE REMOVED. A REPLACEMENT GRYPHON PEEK DS ANCHOR W/OC DEVICE WAS USED TO CONTINUE THE SURGERY, BUT THE SAME ISSUE OCCURRED AGAIN. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22663015 ↗MalfunctionJul 25, 2025Break; Break
IT WAS REPORTED THAT DURING A LABRAL REPAIR PROCEDURE, IT WAS DISCOVERED THAT THE ANCHOR ON THE GRYPHON PEEK DS ANCHOR W/OC DEVICE BROKE OFF. ALL THE BROKEN PARTS WERE REMOVED. IT WAS NOT REPORTED IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE. IT WAS REPORTED THAT A SPARE DEVICE WAS USED TO COMPLETE THE SURGERY. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22608221 ↗MalfunctionMay 8, 2025Break; Break
IT WAS REPORTED THAT DURING A LABRUM REPAIR SURGICAL PROCEDURE IT WAS OBSERVED THAT THE GRYPHON PEEK DS ANCHOR W/OC DEVICE WAS BROKEN OFF. IT WAS REPORTED THAT ALL BROKEN PARTS WERE REMOVED FROM THE PATIENT AND ANOTHER DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO ADDITIONAL INFORMATION COULD BE PROVIDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21988473 ↗MalfunctionMar 19, 2025Break; Break
IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE GRYPHON PEEK DS ANCHOR W/OC DEVICE ANCHOR WAS BROKEN 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 21641564 ↗MalfunctionMay 22, 2024Break; Break
IT WAS REPORTED THAT DURING AN ANKLE ARTHROSCOPIC LIGAMENT REPAIR SURGERY, THE GRYPHON PEEK DS ANCHOR W/OC DEVICE ANCHOR WAS BROKEN OFF, 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 19372241 ↗MalfunctionApr 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT THE GRYPHON PEEK DS ANCHOR W/OC DEVICE SURTURE DETACHED FROM THE ANCHOR. 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 19179255 ↗MalfunctionMar 14, 2024Migration; Migration
THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A MEDIAL PATELLA-FEMORAL LIGAMENT (MPFL) PROCEDURE, IT WAS OBSERVED THAT AFTER THE PROCESS OF IMPLANTING A BONE CANAL, THE ANCHOR ON THE GRYPHON PEEK DS ANCHOR W/OC DEVICE PULLED OUT. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. 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 18905305 ↗MalfunctionMar 14, 2024Migration; Migration
THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A MEDIAL PATELLA-FEMORAL LIGAMENT (MPFL) PROCEDURE, IT WAS OBSERVED THAT AFTER THE PROCESS OF IMPLANTING A BONE CANAL, THE ANCHOR ON THE GRYPHON PEEK DS ANCHOR W/OC DEVICE PULLED OUT. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY, THE SAME PROBLEM HAPPENED AGAIN. 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 18905159 ↗MalfunctionMar 7, 2024Break; Break
IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A RECONSTRUCTION OF THE MEDIAL PATELLOFEMORAL LIGAMENT PROCEDURE, IT WAS OBSERVED THAT THE ANCHOR ON THE GRYPHON PEEK DS ANCHOR W/OC 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 18856278 ↗MalfunctionFeb 8, 2024Break; Break
IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT THE ANCHOR ON THE GRYPHON PEEK DS ANCHOR W/ORTHOCORD DEVICE WAS BROKEN. REMOVED ALL THE BROKEN PARTS. 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 18666552 ↗MalfunctionJan 18, 2024Break; Break
THIS IS REPORT 1 OF 2 FOR (B)(4) IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT THE ANCHOR ON THE GRYPHON PEEK DS ANCHOR W/ORTHOCORD DEVICE WAS BROKEN OFF. REMOVED ALL THE BROKEN PARTS. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY BUT THE SAME PROBLEM HAPPENED AGAIN. 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 18534419 ↗MalfunctionJan 18, 2024Break; Break
THIS IS REPORT 2 OF 2 FOR (B)(4) . IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE ON (B)(6) 2024, IT WAS OBSERVED THAT THE ANCHOR ON THE GRYPHON PEEK DS ANCHOR W/ORTHOCORD DEVICE WAS BROKEN OFF. REMOVED ALL THE BROKEN PARTS. CHANGED TO ANOTHER ONE TO CONTINUE THE SURGERY BUT THE SAME PROBLEM HAPPENED AGAIN. 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 18534417 ↗MalfunctionNov 9, 2023Break; Break
IT WAS REPORTED BY THE SALES REP IN CHINA THAT DURING A STRENGTHENING FIXATION OF THE ANTERIOR TALOFIBULAR LIGAMENT OF THE ANKLE JOINT SURGICAL PROCEDURE ON (B)(6) 2023 IT WAS OBSERVED THAT THE GRYPHON PEEK DS ANCHOR W/OC WAS BROKEN OFF. IT WAS REPORTED THAT ALL BROKEN PARTS WERE REMOVED. IT WAS REPORTED THAT 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 18106551 ↗MalfunctionAug 29, 2023Break; Break
IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE ANCHOR ON THE GRYPHON PEEK DS ANCHOR W/ORTHOCORD 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 17645030 ↗MalfunctionJul 28, 2023Break; Break
IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION PROCEDURE ON (B)(6) 2023, IT WAS OBSERVED THAT THE ANCHOR ON THE GRYPHON PEEK DS ANCHOR W/ORTHOCORD 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 17414229 ↗MalfunctionMay 24, 2023Break; Break
THIS IS REPORT 4 OF 4 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN UNKNOWN PROCEDURE OF THE ELBOW ON (B)(6) 2023, IT WAS OBSERVED THAT THE ANCHOR ON THE GRYPHON PEEK DS ANCHOR W/ORTHOCORD DEVICE WAS BROKEN OFF. REMOVED ALL THE BROKEN PARTS. CHANGED TO ANOTHER THREE TO CONTINUE THE SURGERY BUT THE SAME PROBLEM HAPPENED AGAIN. 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 16995970 ↗MalfunctionMay 24, 2023Break; Break
THIS IS REPORT 2 OF 4 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN UNKNOWN PROCEDURE OF THE ELBOW ON (B)(6) 2023, IT WAS OBSERVED THAT THE ANCHOR ON THE GRYPHON PEEK DS ANCHOR W/ORTHOCORD DEVICE WAS BROKEN OFF. REMOVED ALL THE BROKEN PARTS. CHANGED TO ANOTHER THREE TO CONTINUE THE SURGERY BUT THE SAME PROBLEM HAPPENED AGAIN. 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 16995963 ↗MalfunctionMay 24, 2023Break; Break
THIS IS REPORT 1 OF 4 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN UNKNOWN PROCEDURE OF THE ELBOW ON (B)(6) 2023, IT WAS OBSERVED THAT THE ANCHOR ON THE GRYPHON PEEK DS ANCHOR W/ORTHOCORD DEVICE WAS BROKEN OFF. REMOVED ALL THE BROKEN PARTS. CHANGED TO ANOTHER THREE TO CONTINUE THE SURGERY BUT THE SAME PROBLEM HAPPENED AGAIN. 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 16995920 ↗MalfunctionMay 24, 2023Break; Break
THIS IS REPORT 3 OF 4 FOR (B)(4).. IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN UNKNOWN PROCEDURE OF THE ELBOW ON (B)(6) 2023, IT WAS OBSERVED THAT THE ANCHOR ON THE GRYPHON PEEK DS ANCHOR W/ORTHOCORD DEVICE WAS BROKEN OFF. REMOVED ALL THE BROKEN PARTS. CHANGED TO ANOTHER THREE TO CONTINUE THE SURGERY BUT THE SAME PROBLEM HAPPENED AGAIN. 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 16995913 ↗MalfunctionApr 17, 2023Break; Break
THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A OPEN REDUCTION AND INTERNAL FIXATION PROCEDURE OF THE ULNA ON (B)(6) 2023, IT WAS OBSERVED THAT THE GRYPHON PEEK DS ANCHOR W/ORTHOCORD DEVICE WAS BROKEN OFF. REMOVED ALL THE BROKEN PARTS. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY BUT THE SAME PROBLEM HAPPENED AGAIN. 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 16755981 ↗MalfunctionApr 17, 2023Break; Break
THIS IS REPORT 1 OF 2 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING A OPEN REDUCTION AND INTERNAL FIXATION PROCEDURE OF THE ULNA ON (B)(6) 2023, IT WAS OBSERVED THAT THE GRYPHON PEEK DS ANCHOR W/ORTHOCORD DEVICE WAS BROKEN OFF. REMOVED ALL THE BROKEN PARTS. CHANGED ANOTHER ONE TO CONTINUE THE SURGERY BUT THE SAME PROBLEM HAPPENED AGAIN. 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 16755977 ↗MalfunctionJan 24, 2023Delivered as Unsterile Product; Packaging Problem; Delivered as Unsterile Product; Packaging Problem
IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022, IT WAS OBSERVED THAT THE INNER PACKAGING OF THE GRYPHON PEEK DS ANCHOR W/ORTHOCORD DEVICE WAS DAMAGED UPON OPENING THE OUTER BOX. 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 16233006 ↗MalfunctionOct 20, 2022Break; Break
THIS IS REPORT 5 OF 5 FOR (B)(4). 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 GRYPHON PEEK DS ANCHOR W/ORTHOCORD DEVICE BROKE UPON TIGHTENING. CHANGED TO ANOTHER FOUR SAME DEVICES TO CONTINUE THE SURGERY BUT THE SAME PROBLEM HAPPENED AGAIN. 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 15642289 ↗MalfunctionOct 20, 2022Break; Break
THIS IS REPORT 4 OF 5 FOR (B)(4). 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 GRYPHON PEEK DS ANCHOR WORTHOCORD DEVICE BROKE UPON TIGHTENING. CHANGED TO ANOTHER FOUR SAME DEVICES TO CONTINUE THE SURGERY, BUT THE SAME PROBLEM HAPPENED AGAIN. 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 15642282 ↗MalfunctionOct 20, 2022Break; Break
THIS IS REPORT 2 OF 5 FOR (B)(4). IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL IN CHINA THAT DURING AN UNKNOWN SURGERY ON 10/2/2022, IT WAS OBSERVED THAT THE SUTURE ON THE GRYPHON PEEK DS ANCHOR W/ORTHOCORD DEVICE BROKE UPON TIGHTENING. CHANGED TO ANOTHER FOUR SAME DEVICES TO CONTINUE THE SURGERY BUT THE SAME PROBLEM HAPPENED AGAIN. 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 15642281 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K103712, K150209. One submission often covers many models, so check the product and lot details in each record.
- 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-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
- 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-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
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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