NanoTack CAT01858Recalls & reported problems
Stryker Corporation · NANOTACK SUTURE ANCHOR 1.4MM WITH FLEX INSERTER · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Stryker NanoTack suture anchor is a small plastic anchor, with a flexible inserter, used to attach sutures to bone in minimally invasive joint procedures. The 55 reports mostly describe the anchor or its inserter breaking during surgery, sometimes leaving fragments in the joint or embedded in bone, plus anchors being past their expiration date. Four reports involve injuries and no deaths are described. 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
- 55
- Deaths reported
- 0
- Injuries reported
- 4
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 55 adverse event reports that list this exact device (DI 07613252633099), received between Jun 11, 2018 and Dec 30, 2025 — classified as 4 injuries, 51 malfunctions.
The most frequently reported specific device problem is “Break” (37 reports).
2 other recalls cover devices cleared under the same FDA submission (K131769); 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.
Reports received per month
Most reported problems
Device problems
- Break37
- Expiration Date Error11
- Material Fragmentation5
- Material Deformation4
- Fracture2
- Appropriate Device Problem Term/Code Not Available1
- Detachment of Device or Device Component1
- Improper or Incorrect Procedure or Method1
Patient problems
- No Clinical Signs, Symptoms or Conditions42
- Insufficient Information13
- No Known Impact Or Consequence To Patient9
- Foreign Body In Patient4
- Device Embedded In Tissue or Plaque1
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 25 most recent of 55 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 30, 2025Expiration Date Error; Expiration Date Error
IT WAS REPORTED THAT AN EXPIRED NANOTACK FLEX ANCHOR WAS OPENED AND IMPLANTED INTO A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23926646 ↗MalfunctionSep 3, 2025Break; Material Fragmentation; Break; Material Fragmentation
IT WAS REPORTED THAT THE NANOTACK GUIDE WAS PLACED ON THE ACETABULAR RIM. A NANOTACK DRILL WAS SUCCESSFULLY USED TO CREATE PILOT HOLE WITHOUT AND PROBLEMS. ANCHOR WAS INTRODUCED TO GUIDE AND MALLETED INTO BONE. TRIGGER ARMS ON ANCHOR WERE DEPLOYED, AND GUIDE WAS PULLED FROM JOINT. UPON THE REMOVAL OF THE NANOTACK GUIDE MULTIPLE PEEK FRAGMENTS OF THE NANOTACK FLEX ANCHOR WERE PROTRUDING FROM ACETABULAR RIM. MAJORITY OF ANCHOR REMAINED IN THE BONE BUT ABOUT 30% OF ANCHOR BODY FRAGMENTED INTO THE JOINT. THESE PIECES WERE REMOVED FROM THE JOINT SPACE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22956868 ↗MalfunctionSep 3, 2025Break; Material Fragmentation; Break; Material Fragmentation
IT WAS REPORTED THAT UPON DEPLOYMENT OF THE ANCHOR AND REMOVAL OF THE GUIDE, THE PEEK PORTION OF THE NANOTACK ANCHOR WERE PROTRUDING FROM THE JOINT. THE FRAGMENTED PIECES WERE PULLED FROM THE JOINT AND THE SUTURE PORTION PULLED OUT OF THE LEFTOVER ANCHOR AND OUT OF THE JOINT SPACE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22956858 ↗MalfunctionMay 20, 2025Fracture; Fracture
IT WAS REPORTED THAT AFTER SURGEON UNRAVELED THE SUTURE ON THE INSERTER, IT WAS NOTICED THAT THE FLEXIBLE INSERTER FROM THE ANCHOR HAD BROKEN OFF DISTALLY. THE SURGEON PULLED BACK ON THE INSERTER AND DRILL GUIDE TO PULL THE BROKEN IMPLANT OUT BUT A PIECE OF THE ANCHOR INSERTER BROKE OFF. WITH THE HELP OF X-RAY, THE SURGEON WAS ABLE TO RETRIEVE THE FLOATING PIECE IN THE CAPSULE. THE SURGEON WAS NOT ABLE TO RETRIEVE THE PIECE OF METAL FROM THE INSERTER THAT WAS IMPLANTED INTO THE BONE, SO THE SURGEON WAS ABLE TO BUR DOWN FLAT WITH THE BONE.
Patient problems: Foreign Body In Patient
MAUDE report 22057651 ↗InjuryApr 4, 2025Break; Fracture; Break; Fracture
IT WAS REPORTED THAT THE NANOTACK FLEX ANCHORS HAVE BEEN UNCOILING WHILE REMOVING THE INSERTION HANDLE AND REPORTEDLY CAUSING WEAK POINTS TO OCCUR. IT WAS REPORTED THAT THE INSERTER BROKE UPON ANCHOR DEPLOYMENT AND INSERTER WAS NOT ABLE TO BE REMOVED FROM PATIENT ANATOMY. REPORTEDLY SURGEON WAS NOT WORRIED ABOUT FURTHER HARM.
Patient problems: Foreign Body In Patient
MAUDE report 21775972 ↗InjuryDec 17, 2024Material Fragmentation; Material Fragmentation
IT WAS REPORTED BY THE CUSTOMER THAT "THE TIP OF THE NANO TACK ANCHOR MECHANISM BROKE WHEN BEING MALLETED INTO THE BONE. THE SURGEON NOTED THAT SOME OF THE MECHANISM WOULD BE LEFT IMBEDDED IN THE PATIENTS' BONE AS THEY WERE NOT ABLE TO RETRIEVE IT AFTER THE ANCHOR WENT IN".
Patient problems: Foreign Body In Patient
MAUDE report 20951709 ↗MalfunctionJan 31, 2024Material Fragmentation; Separation Failure; Material Fragmentation; Separation Failure
PER INVESTIGATION RESULTS, THE ANCHOR WAS BROKEN. BASED ON THIS, THE ANCHOR BROKE DURING THE PROCEDURE. THE BROKEN PIECE WAS NOT LEFT IN PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18619853 ↗MalfunctionNov 10, 2023Material Fragmentation; Material Fragmentation
IT WAS REPORTED THAT THE ANCHOR BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18112730 ↗MalfunctionMay 22, 2023Break; Break
IT WAS REPORTED THAT THE ANCHOR BROKE DURING PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16981451 ↗MalfunctionMay 22, 2023Break; Break
IT WAS REPORTED THAT THE ANCHOR BROKE DURING PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16981450 ↗MalfunctionMay 22, 2023Break; Break
IT WAS REPORTED THAT THE ANCHOR BROKE DURING PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16981449 ↗MalfunctionMay 22, 2023Break; Break
IT WAS REPORTED THAT THE ANCHOR BROKE DURING PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16981448 ↗MalfunctionMay 22, 2023Break; Break
IT WAS REPORTED THAT THE ANCHOR BROKE DURING PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16981447 ↗MalfunctionMay 22, 2023Break; Break
IT WAS REPORTED THAT THE ANCHOR BROKE DURING PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16981411 ↗MalfunctionMay 22, 2023Break; Break
IT WAS REPORTED THAT THE ANCHOR BROKE DURING PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16981410 ↗MalfunctionMay 22, 2023Break; Break
IT WAS REPORTED THAT THE ANCHOR BROKE DURING PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16981408 ↗MalfunctionMay 22, 2023Break; Break
IT WAS REPORTED THAT THE ANCHOR BROKE DURING PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16981407 ↗MalfunctionMay 22, 2023Break; Break
IT WAS REPORTED THAT THE ANCHOR BROKE DURING PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16981406 ↗MalfunctionMay 22, 2023Break; Break
IT WAS REPORTED THAT THE ANCHOR BROKE DURING PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16980253 ↗MalfunctionMay 22, 2023Break; Break
IT WAS REPORTED THAT THE ANCHOR BROKE DURING PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16980246 ↗MalfunctionApr 17, 2023Break; Break
IT WAS REPORTED THAT THE ANCHOR BROKE DURING PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16753869 ↗MalfunctionApr 11, 2023Break; Material Deformation; Break; Material Deformation
IT WAS REPORTED THAT THE ANCHOR BROKE DURING PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16718718 ↗MalfunctionApr 4, 2023Break; Break
IT WAS REPORTED THAT THE ANCHOR BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16677634 ↗MalfunctionMar 27, 2023Break; Material Deformation; Break; Material Deformation
IT WAS REPORTED THAT THE ANCHOR BROKE DURING PROCEDURE. PLEASE NOTE THAT THE INITIAL REPORT'S TYPE OF REPORTABLE EVENT WAS A MALFUNCTION FOR THE ANCHOR BREAKING. HOWEVER PER INVESTIGATION RESULTS, THERE WAS NO ANCHOR BREAKAGE, THE ANCHOR WAS ONLY BENT. THEREFORE THIS EVENT IS NOT REPORTABLE AS THERE WAS NO BREAKING OF THE ANCHOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16620779 ↗MalfunctionMar 27, 2023Break; Material Deformation; Break; Material Deformation
IT WAS REPORTED THAT THE ANCHOR BROKE DURING PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16620768 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K131769. One submission often covers many models, so check the product and lot details in each record.
- Z-2645-2023 · Aug 23, 2023 · Open, ClassifiedCinchlock SS Knotless Anchor Inserter, Part Number CAT02462
- Z-1634-2016 · Apr 12, 2016 · TerminatedCinchLock SS Knotless Anchor with Inserter; Model number CAT02462; Orthopedic: The Pivot CinchLock SS Knotless Anchor (CAT02462) and Pivot CinchLock Flex Knotless Anchor (CAT0246
Other FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE devices
- TRUESPAN ORTHOCORD 228151Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,686 reports
- TRUESPAN ORTHOCORD 228152Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1,398 reports
- OMNISPAN ORTHOCORD 228142Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE932 reports
- FOOTPRINT 72202901Smith & Nephew, Inc. · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE721 reports
- RIGIDLOOP 232447Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE633 reports
- Arthrex® AR-3636Arthrex, Inc. · Fastener, fixation, nondegradable, soft tissue624 reports
- OMNISPAN ORTHOCORD 228141Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE609 reports
- TRUESPAN ORTHOCORD 228162Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE460 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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