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

Model Number 20070053

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 08/08/2019

Event Type  Injury  

Manufacturer Narrative

This event will be updated when investigation is complete.

Event 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.

Manufacturer Narrative

Please void this report.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
• Type of Device: HIP INSTRUMENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 9126011
• MDR Text Key: 162796160
• Report Number: 3010536692-2019-01056
• Device Sequence Number: 1
• Product Code: HWP
• UDI-Device Identifier: M684200700531
• UDI-Public: M684200700531
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 20070053
• Device Catalogue Number: 20070053
• Device Lot Number: CN101458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/28/2019
• Date Manufacturer Received: 08/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention