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

Model Number	0362
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/16/2019
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
A healthcare professional (hcp) reported that the notched offset partial ear fell apart while the doctor was placing it on a patient.The device did not make it to the patient.The device was held on an instrument when it fell apart.There was no known patient impact.
Additional Manufacturer Narrative
Analysis found that visually, a portion of the device had broken off.The portion that became detached was not returned however it would have measure approximately 0.2mm.There were multiple dark marks on the surface of the device which were most likely from the holding instrument the customer reported.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PROSTHESIS - CAPCEL
• Common Device Name: REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 9130257
• Report Number: 1045254-2019-00477
• Device Sequence Number: 16722594
• Product Code: ETA
• UDI-Device Identifier: 20681490017880
• UDI-Public: 20681490017880
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K885201
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2019

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: 05/12/2026
• Device Model Number: 0362
• Device Catalogue Number: 0362
• Device Lot Number: 0215453191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2019
• Supplement Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 09/27/2019
• Supplement Report FDA Received Date: 10/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 11 YR