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

Model Number	1112363
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during implantation the device broken.Product had contacted patient and no fragment left in patient.There was no injury to patient.The procedure was completed with backup product and there was a surgical delay of 60 minutes.
Additional Manufacturer Narrative
Device evaluated by mfr: analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
H3 : analysis summary : analysis of returned product of id 1112363 and lot # 0211114735 found that visually, the shaft of the sample was broken which would have resulted in the reported event.Under magnification, a portion of the shaft head of the sample was broken off.Functional testing is not required per d00435338 revision c.A review of the global complaint data showed no other complaints about this lot number.In the returned condition, there was an out of specification condition that is likely related to the complaint due to physical damage.A2,b5 - updated with new information.H6 - previous fdm b21, fdr c21 and fdc d14 codes no longer apply.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
On follow-up it was reported that products break during pre-operation manipulation of the device outside the surgical field.Fragment detached from the broken device.Two products were used and both of them broken in the same procedure.

• Brand Name: PROSTHESIS - CAPCEL
• 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: 13313387
• Report Number: 1045254-2022-00034
• Device Sequence Number: 5076192
• Product Code: ETA
• UDI-Device Identifier: 00681490033671
• UDI-Public: 00681490033671
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K810707
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2022

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: 04/10/2024
• Device Model Number: 1112363
• Device Catalogue Number: 1112363
• Device Lot Number: 0211114735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2022
• Supplement Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 01/21/2022
• Supplement Report FDA Received Date: 02/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2016
• 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 Age: 50 YR
• Patient Sex: Male