MectaLock PEEK Suture Anchor 05.11.002Recalls & reported problems
Medacta International SA · MectaLock PEEK Ø2.9 – Long driver · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630040727815), received between Jul 20, 2023 and Jul 20, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (1 report).
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
Device problems
- Fracture1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 20, 2023Fracture; Fracture
DURING ANCHOR INSERTION, THE SURGEON FELT LIKE A LOT OF FORCE WAS REQUIRED TO MALLET INTO BONE. ONCE THE ANCHOR WAS FULLY IMPLANTED, THE INTRODUCER CAME AWAY FROM THE ANCHOR IMMEDIATELY (WITHOUT NEED FOR COUNTERCLOCKWISE TURNS). THE BROKEN TIP OF THE INSERTER (REF. 66.01.010; MAT 33775) WAS VISIBLE IN THE INTRAOPERATIVE XRAY. IT IS FEASIBLE THAT, DURING THE MALLETING PHASE, THE ANCHOR AND THE INSERTER WERE NOT FULLY AXIALLY ALIGNED WITH THE PILOT HOLE AND THAT THE MALLETING WAS NOT FULLY AXIALLY ALIGNED WITH THE HANDLE OF THE INSERTER. SLOTTED AIMER WAS NOT USED. THE TIP WAS LEFT INSIDE THE PATIENT. SUTURE FIXATION WAS ADEQUATE AND SURGEON USED 2 MORE JLOCK ANCHORS SUCCESSFULLY FOLLOWING AND 1 PRIOR TO THE BREAKAGE. NO REVISION SURGERY IS PLANNED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17361571 ↗
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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