MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® MODULAR NECK REMNANT EXTRACTION PLUG; HIP INSTRUMENT

Model Number PRNEPLUG

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 07/01/2019

Event Type  Injury  

Manufacturer Narrative

This event will be updated when investigation is complete.

Event Description

Allegedly during dr.(b)(6) attempts at removing a broken neck the remnant extraction plug broke.It was after the tapping stage, during the extraction step that this instrument broke in conjunction with the neck extractor (cork screw).Force was applied to the neck extractor and the plug broke at the point it was decided to remove the stem when the new remnant could not be removed.(linked to complaint (b)(4)).Kit number: prnekit2.Lot number: 07.

• Brand Name: PROFEMUR® MODULAR NECK REMNANT EXTRACTION PLUG
• 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: 8881882
• MDR Text Key: 153948374
• Report Number: 3010536692-2019-01006
• Device Sequence Number: 1
• Product Code: HWB
• UDI-Device Identifier: M684PRNEPLUG1
• UDI-Public: M684PRNEPLUG1
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 08/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PRNEPLUG
• Device Catalogue Number: PRNEPLUG
• Device Lot Number: 1393142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/12/2019
• Date Manufacturer Received: 07/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR