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

Model Number	1150001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product is shipped in a ridged capsule which protects the device during shipping.There were no signs that the device was closed in the lid of the capsule.Visually, the flex h/a had become detached from the titanium bell which would have resulted in the reported event.Adhesive is required to bind the two components together and when viewed under magnification, a residue consistent with adhesive was present in the mounting area which likely indicates it was assembled properly.The portion that had become detached was installed on the shaft indicating handling.The flex h/a was removed from the shaft for further analysis.The overall length of the head shaft assembly should be approximately 0.400¿ and the actual measurement was 0.072¿.The shaft configuration is consistent with being cut off.The cam head was bent and contained tool marks.The flex h/a is a porous material measuring approximately 0.045¿ in diameter which makes it vulnerable to mishandling.There was no allegation of a defect prior to handling.There was no evidence of improper manufacturing and therefore has been ruled out as a likely cause.The information most likely indicates the device was modified and the damage occurred while handling.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A healthcare provider (hcp) reported that during a procedure for a cholesteatoma resection, artificial ossicular implantation and tympanoplasty, the artificial ossicular implant was broken during the tympanic portion of the surgery.The surgeon removed the broken device and ¿switched to the autologous ossicle for hearing reconstruction and completed the operation.¿ the patient was alive with no injury.On follow up, it was confirmed there was no procedure delay.There was no patient impact.

• Brand Name: PROSTHESIS - UNIVERSAL TITANIUM PROSTHESIS
• Common Device Name: REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL
• Manufacturer (Section D): MEDTRONIC XOMED INC.; 6743 southpoint dr n; jacksonville FL 32216
• MDR Report Key: 9625835
• Report Number: 1045254-2020-00056
• Device Sequence Number: 19563869
• Product Code: ETA
• UDI-Device Identifier: 00681490909907
• UDI-Public: 00681490909907
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K002897
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/24/2020

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: 11/04/2025
• Device Model Number: 1150001
• Device Catalogue Number: 1150001
• Device Lot Number: 0214341098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2019
• Initial Report FDA Received Date: 01/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 42 MO