MAUDE Adverse Event Report: MEDTRONIC DOMINICANA PROSTHESIS - UNIVERSAL TITANIUM PROSTHESIS; REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL

Model Number	1150000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: product analysis found that visually, the shaft of the round head was broken from the flex h/a when returned.Under magnification, contamination was observed at the break point and the titanium bell, opposite the round head, was bent/deformed when returned.Functional testing is not required per (b)(4) revision d.In the returned condition, there was an out of specification condition that was related to the complaint (due to physical damage).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that during the surgery, when preparing for implantation, it was found that the ossicular prosthesis was broken in t wo pieces and could not be implanted or used normally.This was the first time the ossicular prosthesis was used.The prosthesis was not broken when it was received.The procedure was extended by 2 minutes and was completed with a backup product.There was no patient impact.

• Brand Name: PROSTHESIS - UNIVERSAL TITANIUM PROSTHESIS
• Common Device Name: REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL
• Manufacturer (Section D): MEDTRONIC DOMINICANA; zona franca de san isidro; carretera san isidro, km 17; santo domingo 11500 ; DR 11500
• Manufacturer (Section G): MEDTRONIC DOMINICANA; zona franca de san isidro; carretera san isidro, km 17; santo domingo 11500 ; DR 11500
• Manufacturer Contact: justin ellis ; 6743 southpoint drive north; jacksonville, FL 32216 ; 7635265677
• MDR Report Key: 20319201
• Report Number: 9612501-2024-02489
• Device Sequence Number: 8005302
• Product Code: ETA
• UDI-Device Identifier: 00763000036195
• UDI-Public: 00763000036195
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K002897
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/27/2024

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: 1150000
• Device Catalogue Number: 1150000
• Device Lot Number: 0226369391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2024
• Initial Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2023
• 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: Prefer Not To Disclose