Blox

Description of Event or Problem

It was reported to Boston Scientific Corporation that a Bite Blox was used during a procedure performed on (b)(6) 2026. During the procedure, the Bite Blox device broke during use. The procedure was completed using another of the same device. There were no patient complication as a result of this event.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date. Should additional relevant details become available, a supplemental report will be submitted.

Additional Manufacturer Narrative

Block E1: This event was reported by the distributor. The Healthcare facility is:(b)(6) Hospital.(b)(6). Phone number: (b)(6).Email Address: (b)(6).Fax number: (b)(6).Block D4, H4: The complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.Block H6:IMDRF Device Code A0413 captures the reportable event of Bite Blox Material Separation.