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

Model Number	1150000
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2019
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
A health care provider (hcp) reported via a manufacturer representative that the foot on the actual implant broke off during a mastoidectomy with ossicular chain reconstruction procedure.It was noted that the device was not broken before the surgeon tried to place the implant.The device broke into two pieces, the footplate broke off as the surgeon tried to place it, but both pieces were recovered.There was no delay in the procedure as a result of this event.The procedure was completed with a backup device.There was no patient impact.

• Brand Name: PROSTHESIS - UNIVERSAL TITANIUM PROSTHESIS
• Common Device Name: REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 9145324
• Report Number: 1045254-2019-00485
• Device Sequence Number: 11427167
• Product Code: ETA
• UDI-Device Identifier: 00681490909891
• UDI-Public: 00681490909891
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K002897
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/02/2019

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: 07/30/2021
• Device Model Number: 1150000
• Device Catalogue Number: 1150000
• Device Lot Number: 0207263074
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 10/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 16 YR
• Patient Weight: 77