MAUDE Adverse Event Report: INNOMED, INC. PERIOSTEAL ELEVATOR CURVED

Model Number	3450
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/04/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Report mw5095964 was received at innomed from the center for devices and radiological health on 8/28/2020 with following event description documented: "patient having scheduled knee surgery.In one of the extra instrument trays that is occasionally used.There was a soft tissue elevator noted to be broken.Instrument was taken out of the tray and a new instrument was obtained.Did not reach the patient.No patient harm.Fda safety report id #(b)(4).Response: it is customary for innomed to receive the affected device for evaluation and inspection.Innomed was unable to contact the initial reporter for request of retrieval of the affected device as this information was not provided in the report.Innomed surveyed its internal complaints database to determine if there were any entries of the part with the same described issue.No entries were found.Additionally, current inventory of the part was surveyed for the described issue.None were affected.The device has been on the market since february of 2004, and this is the first issue of its kind.

• Brand Name: PERIOSTEAL ELEVATOR CURVED
• Common Device Name: ELEVATOR
• Manufacturer (Section D): INNOMED, INC.; 103 estus drive; savannah, ga, ga
• MDR Report Key: 10591239
• Report Number: 1833053-2020-00001
• Device Sequence Number: 11625521
• Product Code: HTE
• UDI-Device Identifier: 00840277105547
• UDI-Public: 00840277105547
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/28/2020
• Report Date (Section F): 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3450
• Device Catalogue Number: 3450
• Device Lot Number: 0817MT
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/28/2020
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/28/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 08/06/2020