PREF ARCH NI-TI LOWER .016 LARGE

Description of Event or Problem

It was reported that the patient swallowed a significant portion of a wire (Pref Arch Ni-Ti Lower) that fractured while the patient was eating. The patient sought medical attention, and X-rays were performed every two days for approximately 2.5 weeks to monitor and locate the wire fragment. Laxatives were administered to facilitate passage of the wire, which was subsequently passed naturally.

Additional Manufacturer Narrative

An investigation was conducted for Pref Arch Ni-Ti Lower .016 Large (Part No. 205-0006) associated with the reported concern of the wire that broke while the patient was eating. The evaluation included manufacturing traceability, historical quality performance, and functional testing of retained samples. Based on the results of the investigation, the lot was manufactured in compliance with established processes and specifications. Functional testing of retained samples demonstrated full conformance to mechanical and material requirements with no observed breakage or cracking under test conditions. Given these findings, no manufacturing or material-related nonconformance could be confirmed. The reported condition could not be reproduced using retained product, and the investigation did not identify any indication of a systemic manufacturing or material-related issue within the evaluated lot.