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

Model Number	1156602
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A healthcare professional (hcp) reported that the piston broke whilst being crimped.The broken implant was retrieved and another one was implanted.The product had contact with the patient.It will not be returned as it was discarded by the customer.The reported event resulted in a procedure delay/extended time of 5 minutes.There was no patient impact.The procedure was completed with backup products.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: PROSTHESIS - STAPES
• Common Device Name: REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer (Section G): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• Manufacturer Contact: glen belmer ; 6743 southpoint drive north; jacksonville, FL 32216 ; 6122713209
• MDR Report Key: 13786183
• Report Number: 1045254-2022-00140
• Device Sequence Number: 3824094
• Product Code: ETA
• UDI-Device Identifier: 00721902848209
• UDI-Public: 00721902848209
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K002897
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/16/2022

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: 05/07/2025
• Device Model Number: 1156602
• Device Catalogue Number: 1156602
• Device Lot Number: 0213286447
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2022
• Initial Report FDA Received Date: 03/16/2022
• Date Device Manufactured: 05/09/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown