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

Model Number	1156363
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis found that there was a residue consistent with biological contaminants on the device.Visually, the device was consistent with being bent until broken which would have resulted in the reported event.The two portions returned measured 0.161¿ and 0.118¿ long for a total length of 0.279¿.The overall length shall measure 0.275¿/+-0.010¿ therefore the information most likely indicates all portions of the device were returned.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 prosthesis broke off and detached during an ossicular reconstruction procedure without excess force.The prosthesis was operated with an alligator forceps.This was the first time the device was used.There was no intervention planned and performed.There was a delay of about 5-8 minutes.There was no broken pieces left/remained inside the patient's body.The procedure was completed with back up device.There was no patient impact.

• Brand Name: PROSTHESIS - POLYCEL
• Common Device Name: REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 8577647
• Report Number: 1045254-2019-00225
• Device Sequence Number: 1639225
• Product Code: ETA
• UDI-Device Identifier: 00681490035736
• UDI-Public: 00681490035736
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K823912
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/03/2019

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 Model Number: 1156363
• Device Catalogue Number: 1156363
• Device Lot Number: 0210298025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2019
• Initial Report FDA Received Date: 05/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1