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

Model Number	0550
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The health care provider reported via manufacturer representative that after the physician cut the rod of the prosthesis during the procedure and when they were about the put the prosthesis in the ear, the prosthesis was broken.There was no damaged and no broken pieces remain inside the patients body.There was no delay with the procedure.The procedure was completed with backup product.There was no patient impact.

• Brand Name: PROSTHESIS - FLEX HA
• Common Device Name: REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 8893069
• Report Number: 1045254-2019-00383
• Device Sequence Number: 241050
• Product Code: ETA
• UDI-Device Identifier: 00681490024426
• UDI-Public: 00681490024426
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K904239
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/25/2025
• Device Model Number: 0550
• Device Catalogue Number: 0550
• Device Lot Number: 0213544652
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2019
• Initial Report FDA Received Date: 08/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1