NA 7207003000Recalls & reported problems
Stryker Corporation · Sternum Blade Guard · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This Stryker Sternum Blade Guard is used during surgery to help hold back tissue while a chest incision is worked on. The 29 reports mostly describe the blade tearing the lining tissue of the lung, with skin tears noted in 26 injuries, plus small pieces breaking off or a component coming loose; no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 29
- Deaths reported
- 0
- Injuries reported
- 26
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 07613252204336), received between Aug 12, 2022 and Jul 24, 2024 — classified as 26 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem26
- Detachment of Device or Device Component1
- Insufficient Device Problem Information1
- Material Fragmentation1
- No Apparent Adverse Event1
Patient problems
- Skin Tears26
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
Recent adverse event reports
The 25 most recent of 29 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 24, 2024Material Fragmentation; Material Fragmentation
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD SMALL PIECES BREAKING OFF. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19822982 ↗MalfunctionJan 22, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT IN WHICH THE DEVICE HAD A COMPONENT DETACH. - 1 EVENT HAD PATIENT INVOLVEMENT; NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18556987 ↗MalfunctionOct 31, 2023No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information
THE USER FACILITY REPORTED THAT AN INNOMINATE VEIN WAS HOOKED BY THE STERNUM BLADE GUARD DURING A PROCEDURE. THERE WAS NO PATIENT IMPACT, NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 18041557 ↗InjurySep 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED THAT THE DEVICE WAS TEARING PLEURA TISSUE ON THE PATIENT DURING A PROCEDURE. THE TEAR WAS TREATED BY WOUND DRAINAGE WITH A TUBE. NO FURTHER ADVERSE CONSEQUENCES REPORTED.
Patient problems: Skin Tears
MAUDE report 15463570 ↗InjurySep 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED THAT THE DEVICE WAS TEARING PLEURA TISSUE ON THE PATIENT DURING A PROCEDURE. THE TEARS WERE TREATED BY WOUND DRAINAGE WITH A TUBE.
Patient problems: Skin Tears
MAUDE report 15371584 ↗InjurySep 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED THAT THE DEVICE WAS TEARING PLEURA TISSUE ON THE PATIENT DURING A PROCEDURE. THE TEARS WERE TREATED BY WOUND DRAINAGE WITH A TUBE.
Patient problems: Skin Tears
MAUDE report 15334388 ↗InjuryAug 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED THAT THE DEVICE WAS TEARING PLEURA TISSUE ON THE PATIENT DURING A PROCEDURE. THE TEARS WERE TREATED BY WOUND DRAINAGE WITH A TUBE.
Patient problems: Skin Tears
MAUDE report 15328976 ↗InjuryAug 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED THAT THE DEVICE WAS TEARING PLEURA TISSUE ON THE PATIENT DURING A PROCEDURE. THE TEARS WERE TREATED BY WOUND DRAINAGE WITH A TUBE.
Patient problems: Skin Tears
MAUDE report 15328907 ↗InjuryAug 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED THAT THE DEVICE WAS TEARING PLEURA TISSUE ON THE PATIENT DURING A PROCEDURE. THE TEARS WERE TREATED BY WOUND DRAINAGE WITH A TUBE.
Patient problems: Skin Tears
MAUDE report 15328851 ↗InjuryAug 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED THAT THE DEVICE WAS TEARING PLEURA TISSUE ON THE PATIENT DURING A PROCEDURE. THE TEARS WERE TREATED BY WOUND DRAINAGE WITH A TUBE.
Patient problems: Skin Tears
MAUDE report 15325347 ↗InjuryAug 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED THAT THE DEVICE WAS TEARING PLEURA TISSUE ON THE PATIENT DURING A PROCEDURE. THE TEARS WERE TREATED BY WOUND DRAINAGE WITH A TUBE.
Patient problems: Skin Tears
MAUDE report 15325346 ↗InjuryAug 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED THAT THE DEVICE WAS TEARING PLEURA TISSUE ON THE PATIENT DURING A PROCEDURE. THE TEARS WERE TREATED BY WOUND DRAINAGE WITH A TUBE.
Patient problems: Skin Tears
MAUDE report 15325218 ↗InjuryAug 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED THAT THE DEVICE WAS TEARING PLEURA TISSUE ON THE PATIENT DURING A PROCEDURE. THE TEARS WERE TREATED BY WOUND DRAINAGE WITH A TUBE.
Patient problems: Skin Tears
MAUDE report 15325216 ↗InjuryAug 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED THAT THE DEVICE WAS TEARING PLEURA TISSUE ON THE PATIENT DURING A PROCEDURE. THE TEARS WERE TREATED BY WOUND DRAINAGE WITH A TUBE.
Patient problems: Skin Tears
MAUDE report 15322865 ↗InjuryAug 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED THAT THE DEVICE WAS TEARING PLEURA TISSUE ON THE PATIENT DURING A PROCEDURE. THE TEARS WERE TREATED BY WOUND DRAINAGE WITH A TUBE.
Patient problems: Skin Tears
MAUDE report 15322861 ↗InjuryAug 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED THAT THE DEVICE WAS TEARING PLEURA TISSUE ON THE PATIENT DURING A PROCEDURE. THE TEARS WERE TREATED BY WOUND DRAINAGE WITH A TUBE.
Patient problems: Skin Tears
MAUDE report 15322340 ↗InjuryAug 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED THAT THE DEVICE WAS TEARING PLEURA TISSUE ON THE PATIENT DURING A PROCEDURE. THE TEARS WERE TREATED BY WOUND DRAINAGE WITH A TUBE.
Patient problems: Skin Tears
MAUDE report 15322187 ↗InjuryAug 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED THAT THE DEVICE WAS TEARING PLEURA TISSUE ON THE PATIENT DURING A PROCEDURE. THE TEARS WERE TREATED BY WOUND DRAINAGE WITH A TUBE.
Patient problems: Skin Tears
MAUDE report 15322184 ↗InjuryAug 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED THAT THE DEVICE WAS TEARING PLEURA TISSUE ON THE PATIENT DURING A PROCEDURE. THE TEARS WERE TREATED BY WOUND DRAINAGE WITH A TUBE.
Patient problems: Skin Tears
MAUDE report 15322182 ↗InjuryAug 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED THAT THE DEVICE WAS TEARING PLEURA TISSUE ON THE PATIENT DURING A PROCEDURE. THE TEARS WERE TREATED BY WOUND DRAINAGE WITH A TUBE.
Patient problems: Skin Tears
MAUDE report 15322041 ↗InjuryAug 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED THAT THE DEVICE WAS TEARING PLEURA TISSUE ON THE PATIENT DURING A PROCEDURE. THE TEARS WERE TREATED BY WOUND DRAINAGE WITH A TUBE.
Patient problems: Skin Tears
MAUDE report 15221913 ↗InjuryAug 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED THAT THE DEVICE WAS TEARING PLEURA TISSUE ON THE PATIENT DURING A PROCEDURE. THE TEARS WERE TREATED BY WOUND DRAINAGE WITH A TUBE.
Patient problems: Skin Tears
MAUDE report 15221911 ↗InjuryAug 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED THAT THE DEVICE WAS TEARING PLEURA TISSUE ON THE PATIENT DURING A PROCEDURE. THE TEARS WERE TREATED BY WOUND DRAINAGE WITH A TUBE.
Patient problems: Skin Tears
MAUDE report 15221902 ↗InjuryAug 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED THAT THE DEVICE WAS TEARING PLEURA TISSUE ON THE PATIENT DURING A PROCEDURE. THE TEARS WERE TREATED BY WOUND DRAINAGE WITH A TUBE.
Patient problems: Skin Tears
MAUDE report 15221900 ↗InjuryAug 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED THAT THE DEVICE WAS TEARING PLEURA TISSUE ON THE PATIENT DURING A PROCEDURE. THE TEARS WERE TREATED BY WOUND DRAINAGE WITH A TUBE.
Patient problems: Skin Tears
MAUDE report 15221895 ↗
Other INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT devices
- NA 511.701Synthes GmbH · INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT2,164 reports
- SmartLife 7126-120-000Stryker Corporation · INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT1,065 reports
- NA 05.001.224Synthes GmbH · INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT987 reports
- NA 05.001.206Synthes GmbH · INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT632 reports
- NA 532.021Synthes GmbH · INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT521 reports
- NA 2570-04-501Depuy (Ireland) · INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT500 reports
- NA 532.110Synthes GmbH · INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT433 reports
- NA 05.001.223Synthes GmbH · INSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT397 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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