FIXIT FIXIT Threaded anchor systemRecalls & reported problems
S.B.M · Threaded anchor system for rotator cuff repair - CLASSIC - Ø 4.7 mm · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03760154008846), received between Oct 8, 2024 and Oct 8, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Break” (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.
Reports received per month
Most reported problems
Device problems
- Break1
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.
InjuryOct 8, 2024Break; Break
(B)(4). INCIDENT OCCURED IN FRANCE. EVENT DESCRIPTION COMMUNICATED. "DURING SURGERY PERFORMED ON FRIDAY (B)(6) 2024 BY DR. (B)(6), 2 FIXIT 4.5 1ST ROW ANCHORS HAD THEIR WIRES PULLED OUT. ACCORDING TO DR. (B)(6), THE WIRES CAME OUT OF THE ANCHOR, AS IF THE PART THAT HOLDS THE WIRES INSIDE THE ANCHOR HAD BROKEN OFF. THESE ARE TWO OF THE ANCHORS INSTALLED ON 30/08/2024. THEY INSTALLED TWO OTHER ANCHORS". INCIDENT REPORT RETRIEVED ON 04 OCTOBER 2024 - NO CLINICAL CONSEQUENCES FOR THE PATIENT - NO ADDITIONAL SURGERY - OPERATIVE TIME EXTENDED BY MORE THAN 30MN - ANCHORS REMAINED IN THE PATIENT WITHOUT THE WIRES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20396465 ↗
Other Fastener, Fixation, Biodegradable, Soft Tissue devices
- GRYPHON ORTHOCORD 210813Medos International Sàrl · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE712 reports
- HEALIX ADVANCE 222330Depuy Mitek, LLC · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE1 recall607 reports
- HEALIX ADVANCE ORTHOCORD 222295Medos International Sàrl · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE640 reports
- HEALICOIL 72205137Smith & Nephew, Inc. · Fastener, fixation, biodegradable, soft tissue427 reports
- HEALIX ADVANCE ORTHOCORD 222296Medos International Sàrl · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE320 reports
- TWINFIX 72202597Smith & Nephew, Inc. · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE288 reports
- Arthrex® AR-2324BCCArthrex, Inc. · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE254 reports
- HEALIX ADVANCE 222331Depuy Mitek, LLC · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE1 recall196 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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