MAUDE Adverse Event Report: MEDTRONIC XOMED INC. PROSTHESIS - CAPCEL; REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL

Model Number 1112363

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/01/2022

Event Type  malfunction  

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

A healthcare professional (hcp) reported that the prosthesis broke during the operation.On follow-up, it was reported that the product was broken while being used on a patient, intra-operatively.The product came in contact with the patient.The fragments were not removed, the surgeon repaired the broken item by using cartilage to fuse it and inserted it back into the middle ear of the patient.Additional info received.The procedure was completed within 3 hrs.No unanticipated medical interventions, procedures or treatments were performed.The event occurred during a middle ear mastoidectomy; total replacement.There was no injury to the patient.

• Brand Name: PROSTHESIS - CAPCEL
• Type of Device: REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: glen belmer ; 6743 southpoint drive north; jacksonville, FL 32216 ; 6122713209
• MDR Report Key: 14849741
• MDR Text Key: 302350243
• Report Number: 1045254-2022-00361
• Device Sequence Number: 1
• Product Code: ETA
• UDI-Device Identifier: 00681490033671
• UDI-Public: 00681490033671
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K810707
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1112363
• Device Catalogue Number: 1112363
• Device Lot Number: 0211877616
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/01/2022
• Date Device Manufactured: 08/29/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Male
• Patient Weight: 100 KG