Reporting Tip
MedSun: Newsletter #20, January 2008

Unretrieved Device Fragments

Numerous MedSun reports are received concerning devices which fragment or break during medical procedures. Often these pieces are removed, but in some cases a fragment or piece may be left behind, as in the case of an orthopedic screw or drill bit that breaks off and is embedded in bone. In such cases the clinician may judge that the safest course is to leave the fragment in place.

FDA is interested in learning more about how often patients are told about retained devices, particularly when such information might be important to the patient in the future. For example, an unretrieved metallic fragment might constitute a risk for the patient during an MRI procedure. Alternatively, future problems might occur due to tissue incompatibility or migration of the unretrieved device.

The following questions are of particular interest to our FDA analysts as they review your reports about device fragments. These questions are not intended to place blame or to question a physician’s decision.

•Was the fragment retrieved from the patient? If so, did the retrieval process require additional surgeries? If the fragment was not retrieved, was the patient informed of this? If the retained fragment was metal, was the patient informed that he or she should report this issue prior to undergoing an MRI exam?
•In your opinion, was excessive force or torque used in manipulating the device before it fractured? Were device procedures followed per institutional protocol? Was the break unexpected given the amount of force or torque used?
•Are you able to furnish us with a picture of the broken device?

As always, FDA and MedSun staff appreciate your willingness to share this kind of information in order to help improve patient safety.



MedSun Newsletters are available at www.fda.gov/cdrh/medsun