Piton™ SMK000101Recalls & reported problems
Tornier, Inc. · Class 2 · Implant
Data updated Oct 16, 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 00846832000036), received between Jul 7, 2021 and Jul 7, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (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 16, 2026.
Most reported problems
Device problems
- Material Deformation1
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 7, 2021Material Deformation; Material Deformation
IT WAS REPORTED THAT THE PATIENT UNDERWENT AN OPEN SHOULDER SURGERY - PECTORALIS MAJOR TENDON REPAIR. THE SURGEON PLANNED TO USE 3 PITON ANCHORS TO REPAIR THE RUPTURED TENDON, PROXIMAL HUMERUS. FIRST ANCHOR DEPLOYED, AS PER STANDARD TECHNIQUE, WITHOUT INCIDENT. SURGEON COMMENTED THAT PATIENT'S BONE "WAS VERY HARD". 2ND HOLE MADE USING AWL, IT WAS VERY DIFFICULT TO REMOVE AWL. THE SUTURE (ALREADY THROUGH TENDON) LOADED INTO ANCHOR. SURGEON KEPT THIS SUTURE UNDER TENSION DURING ANCHOR INSERTION AND ON DEPLOYMENT OF ANCHOR, ONE SUTURE LIMB WAS CUT. A 3RD HOLE WAS MADE, INFERIOR TO PREVIOUS 2; SUTURE LOADED INTO THIS 3RD ANCHOR, AWL USED, ANCHOR DEPLOYED. HOWEVER SURGEON NOTED THAT THE ANCHOR WAS NOT FULLY INSERTED INTO HOLE, AND THE ANCHOR WAS DEPLOYED MID-BONE (NOT FULLY INSERTED). THE SURGEON UNABLE TO REMOVE ANCHOR, DECIDED TO PUSH ANCHOR FULLY INTO HOLE USING SMALL BONE PUNCH, WHICH WAS SUCCESSFUL. SURGEON DECIDED TO IMPLANT A 4TH ANCHOR USING THE 3.5 AWL TO MAKE HOLE. BONE STILL VERY HARD AND THE SURGEON STRUGGLED TO SEAT ANCHOR FULLY INTO HOLE. THE ANCHOR "JAMMED" HALF WAY IN; THE SURGEON REMOVED THE ANCHOR WITH DIFFICULTY. ON INSPECTION, THIS ANCHOR HAD BEEN DAMAGED ON INSERTIO
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12131484 ↗
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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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