Integrity Orthopaedics 901003Recalls & reported problems
Integrity Orthopaedics, Inc · Tendon Seam™ Instrument Kit - 8 Anchor · Class 2
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 00860013905934), received between Apr 20, 2026 and Apr 20, 2026 — classified as 1 injury.
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 16, 2026.
Reports received per month
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.
InjuryApr 20, 2026Fracture
ON 27 MARCH 2026, INTEGRITY ORTHO BECAME AWARE OF A COMPLAINT ASSOCIATED WITH A ROTATOR CUFF REPAIR PROCEDURE IN WHICH THE INTEGRITY ORTHO TENDON SEAM SYSTEM INSTRUMENT ASSEMBLY AND INSTRUMENTS FROM ANOTHER MANUFACTURER WERE USED. DURING THE PROCEDURE, THE SURGEON OBSERVED A SMALL PIECE OF MATERIAL ON THE SURFACE OF THE ROTATOR CUFF, DESCRIBED AS APPROXIMATELY THE SIZE OF A GRAIN OF SUGAR OR SALT AND SUSPECTED TO BE METALLIC IN COMPOSITION. THE MATERIAL WAS REMOVED INTRAOPERATIVELY USING A SURGICAL SHAVER AND DISCARDED, AND THE PROCEDURE CONTINUED. THE IDENTIFICATION AND REMOVAL OF THIS MATERIAL CONSTITUTED MEDICAL INTERVENTION TO PRECLUDE POTENTIAL IMPAIRMENT AND THEREFORE MEETS THE DEFINITION OF A SERIOUS INJURY; THIS IS THE BASIS FOR MEDICAL DEVICE REPORTING IN THIS CASE. DURING THE SAME PROCEDURE, RESISTANCE WAS REPORTED DURING PLACEMENT OF ONE ANCHOR (ANCHOR 5). FOLLOWING ANCHOR DELIVERY AND PUNCH RETRACTION, THE ANCHOR DID NOT REMAIN SEATED IN BONE AND WAS CLIPPED AND REMOVED INTRAOPERATIVELY IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE, WHICH ADDRESS MANAGEMENT OF UNSEATED ANCHORS AS A KNOWN INTRAOPERATIVE OCCURRENCE. THIS EVENT DID NOT RESULT IN PATIENT INJURY, DID NOT REQUI
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24933035 ↗
Other Fastener, Fixation, Nondegradable, Soft Tissue devices
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- OMNISPAN ORTHOCORD 228142Medos International Sàrl · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE932 reports
- FOOTPRINT 72202901Smith & Nephew, Inc. · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE721 reports
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- 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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