NA 03.501.453Recalls & reported problems
Synthes GmbH · MATRIXSTERNUM SCREW GUIDE LARGE/8 HOLES · Class 2
Data updated Oct 18, 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 10887587078267), received between Oct 27, 2025 and Oct 27, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Entrapment of Device” (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.
Reports received per month
Most reported problems
Device problems
- Entrapment of Device1
- Improper or Incorrect Procedure or Method1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 27, 2025Entrapment of Device; Improper or Incorrect Procedure or Method; Entrapment of Device; Improper or Incorrect Procedure or Method
IT WAS REPORTED THAT THE CARDIAC TEAM WAS FINISHING A CABG AND USING THE MATRIXSTERNUM SYSTEM TO CLOSE THE STERNUM. THE SURGICAL TEAM HAD ALREADY STARTED IMPLANTING HARDWARE BEFORE THE SALES REPRESENTATIVE ARRIVED. WHEN THE SALES REPRESENTATIVE ENTERED, ONE OF THE TEAM STATED THAT "THE SCREW WENT RIGHT THROUGH THE STERNUM". THE TEAM HAD FORGOTTEN TO ATTACH THE PLATE TO THE BOTTOM OF THE SPEED GUIDE. SINCE THERE WAS NO PLATE AFFIXED TO THE SPEED GUIDE, WHEN THEY WENT TO IMPLANT THE SCREW, THE SCREW WAS INSERTED THROUGH THE STERNUM. MULTIPLE HCPS SCRUBBED IN AND ATTEMPTED TO LOCATE THE SCREW. BOTH X-RAY AND C-ARM WERE UTILIZED INTRA-OP TO LOCATE THE SCREW. THE TEAM WAS UNABLE TO LOCATE THE SCREW. AN OVERNIGHT CT CONFIRMED THE LOCATION OF THE SCREW - IT WAS INSERTED INTO THE LEFT VENTRICLE OF THE HEART. THE TEAM PLANS TO BRING THE PATIENT BACK INTO THE OR TO RETRIEVE THE SCREW. SURGERY WAS DELAYED BY 240 MINUTES. MULTIPLE HCPS SCRUBBED IN TO LOCATE THE SCREW IN THE CHEST WALL. X-RAY AND C-ARM WERE UTILIZED TO LOCATE THE SCREW AND ATTEMPTS WERE UNSUCCESSFUL. THE TEAM WAS NOT ABLE TO LOCATE IT INTRA-OP AND ORDERED AN OVERNIGHT CT TO GET A BETTER VISUAL. OVERNIGHT CT CONFIRMED LOCATION O
Patient problems: Foreign Body In Patient
MAUDE report 23393278 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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