NA 511.904Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886982238115), received between Jan 4, 2021 and Feb 5, 2024 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Slipped” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2024Mechanical Jam; Mechanical Jam

  IT WAS REPORTED FROM GERMANY THAT DURING SERVICE AND REPAIR/PRE-TESTING, IT WAS OBSERVED THAT THE ATTACHMENT DEVICE WOULD NOT MOVE / WAS FROZEN. THE DEVICE ALSO FAILED PRETESTS FOR CHECK FIXING ON ATTACHMENT. THIS EVENT DID NOT OCCUR DURING SURGERY. THERE WAS NO PATIENT INVOLVEMENT. THERE WERE NO REPORTS OF INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. THE DATE OF EVENT WAS UNKNOWN BUT WAS KNOWN TO HAVE OCCURRED IN 2024. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18640483 ↗
• MalfunctionJan 4, 2021Device Slipped; Premature Separation; Device Slipped; Premature Separation

  THIS IS EVENT 3 OF 3 OF THE SAME EVENT. IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE STERNUM TOP DEVICE FOR THE RECIPROCATING SAW ATTACHMENT DEVICE LOOSENED ITSELF TWICE FROM THE SAW ATTACHMENT FOR THE TRAUMA RECON SYSTEM. IT WAS UNKNOWN IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT. IT WAS REPORTED THAT THERE WAS NO PARTS LEFT INSIDE THE PATIENT. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11108353 ↗
• MalfunctionJan 4, 2021Device Slipped; Premature Separation; Device Slipped; Premature Separation

  THIS IS EVENT 2 OF 3 OF THE SAME EVENT. IT WAS REPORTED FROM (B)(6) THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE, IT WAS OBSERVED THAT THE STERNUM TOP DEVICE FOR THE RECIPROCATING SAW ATTACHMENT DEVICE LOOSENED ITSELF TWICE FROM THE SAW ATTACHMENT FOR THE TRAUMA RECON SYSTEM. IT WAS UNKNOWN IF THERE WERE ANY DELAYS TO THE SURGICAL PROCEDURE OR IF A SPARE DEVICE WAS AVAILABLE FOR USE. THERE WAS PATIENT INVOLVEMENT. IT WAS REPORTED THAT THERE WAS NO PARTS LEFT INSIDE THE PATIENT. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11108339 ↗