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

Model Number	3450
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/15/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Report mw5083220 was received at innomed from the center for devices and radiological health on 2/4/2019 with following event description documented: patient in surgery for total hip arthroplasty.A periosteal elevator (chisel type product) # 3450 being utilized by the surgeon broke.All pieces retrieved.No harm to patient.Referred to manager of central sterile to address.Response: innomed contacted the initial reporter on the day the device was received and requested to have it returned for an evaluation.Return authorization number (b)(4) and sterilization confirmation form were forwarded on the above referenced date.The internal complaints database was surveyed for the above described issue.Upon receipt at innomed on 2/11/2019, the device was inspected and evaluated by quality control.The following results were documented: performed evaluation of failure and found damage to the working end that indicates the instrument was used in a lever motion on a hard object.See attached pictures.The tip in three places is rolled downward indicating a force was used that exceeded the force required to elevate periosteal tissue.This instrument was designed to elevate the periosteal tissue and should not be used to chisel or elevate hard objects.Based on evaluation findings, it was determined that the failure was not a result of design, material, or production failure.Misuse appears to be the root cause of the failure.No other damage was noted to instrument.The device has been on the market for since 2004, and this is the first complaint received.Innomed's capa log was also surveyed for the above described issue, and no entries were found.

• Brand Name: PERIOSTEAL ELEVATOR-CURVED
• Common Device Name: TISSUE ELEVATOR
• Manufacturer (Section D): INNOMED, INC.; 103 estus drive; savannah, ga GA 31404
• MDR Report Key: 8387106
• Report Number: 1833053-2019-00001
• Device Sequence Number: 13995957
• Product Code: HTE
• UDI-Device Identifier: 00840277105547
• UDI-Public: 00840277105547
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/13/2019
• Report Date (Section F): 02/13/2019

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: 3450
• Device Catalogue Number: 3450
• Device Lot Number: 0817MT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2019
• Was the Report Sent to FDA?: Yes
• Device Age: 18 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/04/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/04/2019
• Patient Sequence Number: 1
• Date Report Sent to FDA: 02/13/2019