MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ROUND CALCAR PUNCH MEDIUM; HIP INSTRUMENT

Model Number	20070053
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated when investigation is complete.
Event or Problem Description
Allegedly, universal handle: breaking of the teeth conjunction broach tip zelpi retractors: the self retaining teeth doesn't keep the position round calcars: breaking of the conjunction fillet.Surgery was extended greater than 30 minutes.
Additional Manufacturer Narrative
Additional information received by reporter reveals that this is a non-reportable incident.No serious injury occurred in this incident.

• Brand Name: ROUND CALCAR PUNCH MEDIUM
• Common Device Name: HIP INSTRUMENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9126012
• Report Number: 3010536692-2019-01055
• Device Sequence Number: 19481094
• Product Code: HWP
• UDI-Device Identifier: M684200700531
• UDI-Public: M684200700531
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2020

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: Other
• Device Model Number: 20070053
• Device Catalogue Number: 20070053
• Device Lot Number: CN101275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/28/2019
• Initial Date Received by Manufacturer: 09/26/2019
• Supplement Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 01/14/2020
• Patient Sequence Number: 1