Symmetry Mayo Classic® 36-2017Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887482009710), received between Jul 2, 2025 and Jul 15, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (2 reports).

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 15, 2025Break; Entrapment of Device

  A NEEDLE DRIVER WAS FOUND IN STERILE PROCESSING TO BE MISSING A LAYER OF THE INNER TIP. THE INSTRUMENT WAS PULLED FROM SERVICE. THE QUALITY ASSURANCE TEAM CONNECTED AND CONFIRMED THE RESULTS OF THE PATHOLOGY SPECIMEN, A 1 MM X ~2 MM METALLIC FLAKE OF A TEXTURED GRIPPING SURFACE, TO THE SEQUESTERED NEEDLE DRIVER. THIS METAL FLECK WAS IN THE PATIENT IN THE WOUND, FOUND ON ROUTINE POST OPERATIVE XRAY, LIKELY BROKE OFF DURING SUTURING/CLOSING THE WOUND. THE NEEDLE DRIVER/HOLDER WAS STILL FUNCTIONAL, AND THE BROKEN OFF FLECK WAS SO SMALL, IT WAS NOT IDENTIFIED AT TIME OF USE ON THE PATIENT. THE PATIENT DID RETURN TO THE OR FOR REMOVAL OF THE FOREIGN OBJECT.

  Patient problems: Foreign Body In Patient

  MAUDE report 22505785 ↗
• InjuryJul 2, 2025Break; Material Fragmentation; Break; Material Fragmentation

  WE RECEIVED ADDITIONAL INFORMATION ON JULY 15, 2025, VIA MEDSUN REPORT (B)(4). IT HAS BEEN CONFIRMED THAT REPORT IS THE SAME COMPLAINT. IN THIS REPORT, WE DISCOVERED THAT THERE WAS A SERIOUS INJURY. THAT REPORT STATED "A NEEDLE DRIVER WAS FOUND IN STERILE PROCESSING TO BE MISSING A LAYER OF THE INNER TIP. THE INSTRUMENT WAS PULLED FROM SERVICE. THE QUALITY ASSURANCE TEAM CONNECTED AND CONFIRMED THE RESULTS OF THE PATHOLOGY SPECIMEN, A 1 MM X 2 MM METALLIC FLAKE OF A TEXTURED GRIPPING SURFACE, TO THE SEQUESTERED NEEDLE DRIVER. THIS METAL FLECK WAS IN THE PATIENT IN THE WOUND, FOUND ON ROUTINE POST OPERATIVE XRAY, LIKELY BROKE OFF DURING SUTURING/CLOSING OF THE WOUND. THE NEEDLE DRIVER/HOLDER WS STILL FUNCTIONAL, AND THE BROKEN OFF FLECK WAS SO SMALL, IT WAS NOT IDENTIFIED AT TIME OF USE ON PATIENT. THE PATIENT DID RETURN TO THE OR FOR REMOVAL OF THE FOREIGN OBJECT."

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 22385156 ↗