PEEK Zip 3910-200-035Recalls & reported problems
Stryker Corporation · 5.5MM PEEK ZIP SUTURE ANCHOR WITH 2 STRANDS #2 FORCE FIBER · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 11
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07613154644537), received between Aug 21, 2018 and Sep 18, 2023 — classified as 2 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Break” (9 reports).
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 16, 2026.
Most reported problems
Device problems
- Break9
- Expiration Date Error2
- Material Fragmentation2
- Device Markings/Labelling Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- No Known Impact Or Consequence To Patient4
- Insufficient Information3
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2023Break; Material Fragmentation; Break; Material Fragmentation
IT WAS REPORTED THAT ANCHOR BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17769605 ↗MalfunctionSep 18, 2023Break; Material Fragmentation; Break; Material Fragmentation
IT WAS REPORTED THAT ANCHOR BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17769602 ↗MalfunctionJul 24, 2023Break; Break
IT WAS REPORTED THAT THE TIP OF THE DEVICE BROKE DURING THE PROCEDURE. THE PIECE WAS RETRIEVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17375799 ↗MalfunctionDec 1, 2022Expiration Date Error; Device Markings/Labelling Problem; Expiration Date Error
IT WAS REPORTED THAT AN EXPIRED PRODUCT WAS USED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 15897434 ↗MalfunctionDec 14, 2021Break; Break
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 13006305 ↗MalfunctionApr 28, 2021Break; Break
IT WAS REPORTED THAT THE DEVICE BROKE DURING THE PROCEDURE. ALL PIECES WERE RETRIEVED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 11737296 ↗MalfunctionNov 6, 2019Expiration Date Error
IT WAS REPORTED THAT AN EXPIRED DEVICE WAS USED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9284962 ↗MalfunctionApr 8, 2019Break
IT WAS REPORTED THAT THE ANCHOR BROKE DURING THE PROCEDURE. ALL BROKEN PIECES WERE RETRIEVED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8491490 ↗InjuryMar 13, 2019Break
IT WAS REPORTED THAT THE TIP BROKE AND POTENTIALLY REMAINED IN THE PATIENT'S JOINT SPACE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8416895 ↗InjuryMar 12, 2019Break
IT WAS REPORTED THAT THE TIP BROKE AND POTENTIALLY REMAINED IN THE PATIENT'S JOINT SPACE.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8413457 ↗MalfunctionAug 21, 2018Break
IT WAS REPORTED THAT THE ANCHOR BROKE. ALL PIECES WERE RETRIEVED FROM THE PATIENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7803101 ↗
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 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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