MAUDE Adverse Event Report: MEDTRONIC XOMED INC. PROSTHESIS - FLEX HA

Model Number 0541

Device Problem Break (1069)

Patient Problems Hearing Impairment (1881); Failure of Implant (1924); Foreign Body In Patient (2687)

Event Date 11/22/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

A healthcare provider (hcp) reported via a manufacturer representative that after an implantation of an ossicular prosthesis in 2017, the patient heard well for a while, when suddenly hearing was reduced.After a time, it was noted that a slight extrusion had occurred due to dislocation of the broken implanted prosthesis.A second surgery to remove the broken prosthesis and replace with a new one was carried out on (b)(6) 2019.

Event Description

On follow-up, it was reported that the broken prosthesis was discovered prior to surgery.

Manufacturer Narrative

Correction for h6: c34620 applies instead of c50603.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.

Manufacturer Narrative

H3: analysis found the cylindrical flex h.A.Portion of the device was detached which would have resulted in the reported event.The detached portion measured 0.080¿ long.The drawing requires the area in question to be attached with adhesive.Under magnification adhesive was present on both mounting surfaces as intended and there was no damage to the inside diameter of the flex h.A.The inside dimeter of the mounting surface shall measure 0.054¿ / +0.001¿ / -0.000¿ and measured 0.0545¿ using a pin gage which is in tolerance.The secondary inside diameter shall be 0.045¿ / +- 0.001¿ and measures 0.044¿ which is in tolerance.There was no evidence of improper manufacturing and therefore has been ruled out as a likely cause.The device was not returned with its finish goods package which is an indicator that the device was not found damaged within its package.Although misuse cannot be ruled out as a potential cause or contributing factor as it relates to the event, the information more likely indicates a handling issue resulted in the det achment of the component.H6: the fdm 4114, fdr 3221 and fdc 67 are no longer applicable.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.

• Brand Name: PROSTHESIS - FLEX HA
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 9475196
• MDR Text Key: 174357871
• Report Number: 1045254-2019-00676
• Device Sequence Number: 1
• Product Code: ETA
• Combination Product (y/n): N
• PMA/PMN Number: K904239
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0541
• Device Catalogue Number: 0541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2020
• Date Manufacturer Received: 05/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention