MAUDE Adverse Event Report: GRACE MEDICAL, INC. DORNHOFFER ALTO TOTAL W/SHOE & WINDOWS; REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL

Model Number	626
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	10/26/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A complaint was received on part number 626, dornhoffer alto total implant, for a broken head during implantation.Upon further inquiry, it was revealed that the surgeon determined that the original sizing of the implant was too long and needed to be shortened.The device was shortened without the provided implant adjuster during which, the head was broken and the shaft bent.Further investigation was taken to review three other 626, dornhoffer alto total implants of the same manufacturing lot.These devices met the specifications.The dornhoffer style ha head with windows has 10+ years of clinical history with grace medical in which no valid product complaints have been received.The physician reported that he did not believe that the device caused or contributed to the patient's condition which required surgical intervention.Additionally, the physician reported that the patient was in good condition post-op with regular post-op course (treatment with tylenol with codeine for pain).
Event or Problem Description
It was reported that the device broke while being implanted.The physician reported that the device was too long and needed to be adjusted/shortened.Surgery was completed with a replacement device, but the surgery was delayed.

• Brand Name: DORNHOFFER ALTO TOTAL W/SHOE & WINDOWS
• Common Device Name: REPLACEMENT, OSSICULAR PROSTHESIS, TOTAL
• Manufacturer (Section D): GRACE MEDICAL, INC.; 8500 wolf lake drive; suite 110; memphis TN 38133 4104
• MDR Report Key: 7050004
• Report Number: 1000022662-2017-00010
• Device Sequence Number: 11077694
• Product Code: ETA
• UDI-Device Identifier: 00844505006958
• UDI-Public: 00844505006958
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K061853
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Expiration Date: 04/28/2022
• Device Model Number: 626
• Device Catalogue Number: 626
• Device Lot Number: 56720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2017
• Initial Report FDA Received Date: 11/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 47 YR
• Patient Weight: 62