PEEK IntraLine 3910-400-010Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 07613154644568), received between Sep 1, 2020 and Oct 21, 2025 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (13 reports).

5 other recalls cover devices cleared under the same FDA submission (K071157); 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 21, 2025Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT THE PROXIMAL END OF THE ANCHOR BROKE DURING INSERTION AT THE POINT WHERE THE ANCHOR INSERTER ENDS IN THE ANCHOR. A NEW ANCHOR WAS USED TO COMPLETE THE PROCEDURE. ALL BROKEN PARTS WERE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23353123 ↗
• MalfunctionOct 21, 2025Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT THE PROXIMAL END OF THE ANCHOR BROKE DURING INSERTION AT THE POINT WHERE THE ANCHOR INSERTER ENDS IN THE ANCHOR. A NEW ANCHOR WAS USED TO COMPLETE THE PROCEDURE. ALL BROKEN PARTS WERE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23353122 ↗
• MalfunctionOct 21, 2025Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT THE PROXIMAL END OF THE ANCHOR BROKE DURING INSERTION AT THE POINT WHERE THE ANCHOR INSERTER ENDS IN THE ANCHOR. A NEW ANCHOR WAS USED TO COMPLETE THE PROCEDURE. ALL BROKEN PARTS WERE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23351123 ↗
• MalfunctionSep 10, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THERE WAS BREAKAGE OF PEEK PART OF PEEK INTRALINE ANCHOR POST DRILLING AND TAPPING. ALL PIECES WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23022295 ↗
• MalfunctionSep 10, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THERE WAS BREAKAGE OF PEEK PART OF PEEK INTRALINE ANCHOR POST DRILLING AND TAPPING. ALL PIECES WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23022294 ↗
• MalfunctionSep 10, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THERE WAS BREAKAGE OF PEEK PART OF PEEK INTRALINE ANCHOR POST DRILLING AND TAPPING. ALL PIECES WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23022286 ↗
• MalfunctionJun 5, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT WHILE PLACING IN THE ANCHOR POST TAPPING WHILE FIXATING THE SCREW STARTED TO PULL OFF. THIS WAS A BREAKAGE. ALL PIECES WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22154558 ↗
• MalfunctionOct 2, 2024Material 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 20355605 ↗
• MalfunctionOct 2, 2024Material 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 20355599 ↗
• MalfunctionAug 15, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE ANCHOR BROKE DURING PROCEDURE. ALL PIECES WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17552569 ↗
• MalfunctionAug 15, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE ANCHOR BROKE DURING PROCEDURE. ALL PIECES WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17552566 ↗
• MalfunctionAug 8, 2023Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE ANCHOR BROKE DURING PROCEDURE. ALL PIECES WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17484509 ↗
• MalfunctionAug 7, 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 17476062 ↗
• MalfunctionDec 21, 2022Break

  IT WAS REPORTED THAT THE ANCHOR BROKE DURING PROCEDURE. ALL PIECES WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16024580 ↗
• MalfunctionDec 15, 2022Break

  IT WAS REPORTED THAT THE ANCHOR BROKE DURING PROCEDURE. ALL PIECES WERE RETRIEVED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15988485 ↗
• MalfunctionNov 10, 2021Break

  IT WAS REPORTED THAT THE ANCHOR BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12789405 ↗
• MalfunctionDec 17, 2020Break

  IT WAS REPORTED THAT THE ANCHOR BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11032213 ↗
• MalfunctionDec 16, 2020Break; 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 11016258 ↗
• MalfunctionDec 9, 2020Break

  IT WAS REPORTED THAT THE ANCHOR BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 10979957 ↗
• MalfunctionSep 1, 2020Break

  IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10477804 ↗
• MalfunctionSep 1, 2020Break

  IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10477683 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071157. One submission often covers many models, so check the product and lot details in each record.

• Z-0618-2011 · Aug 20, 2009 · Terminated
  Stryker Titanium Intraline Anchor, Model Numbers 3910400050, 3910400055, 3910400060, 3910400065, Soft Eyelet Anchor, manufactured by Stryker Endoscopy, Puerto Rico
• Z-1534-2008 · Feb 7, 2008 · Terminated
  Stryker Peek Intraline Anchor, 5.5 mm with Needles, Model number 3910-400-015 Used for tissue fixation to bone in certain areas.
• Z-1533-2008 · Feb 7, 2008 · Terminated
  Stryker Peek Intraline Anchor, 5.5 mm, Model number 3910-400-010 Used for tissue fixation to bone in certain areas.
• Z-1536-2008 · Feb 7, 2008 · Terminated
  Stryker Peek Intraline Anchor, 6.5 mm with Needles, Model number 3910-400-025 Used for tissue fixation to bone in certain areas.
• Z-1535-2008 · Feb 7, 2008 · Terminated
  Stryker Peek Intraline Anchor, 6.5 mm, Model number 3910-400-020 Used for tissue fixation to bone in certain areas.