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	03/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis found that the device shaft was broken.The two portions returned measured 0.121¿ and 0.134¿ long for a total length of 0.255¿.The overall length shall measure 0.275¿/+-0.010".There was a residue consistent with biological contaminants on the device.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A health care provider (hcp) via a distributor reported that a prosthesis broke into two pieces during ossicular reconstruction surgery.The hcp made sure that no fragments remained inside the patient's body and noted that the device was handled gently without improper force.The procedure was completed using a back-up product.There was a procedure delay of 10 minutes.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: 8547537
• Report Number: 1045254-2019-00210
• Device Sequence Number: 361466
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/24/2019

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: 0205886574
• 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: 03/29/2019
• Initial Report FDA Received Date: 04/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1