MAUDE Adverse Event Report: CONVENTUS ORTHOPAEDICS, INC. CONVENTUS PHS SYSTEM; NAIL, FIXATION, BONE

Model Number 6650-1

Device Problem Material Discolored (1170)

Patient Problem No Patient Involvement (2645)

Event Date 08/27/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is in progress.Follow-up report(s) will be submitted upon obtaining any additional information.

Event Description

On (b)(6) 2019, (b)(6) received an email from a distributor stating that a distal screw-targeting jig of the ph instrument set was slightly discolored and looked rusty.The distributor requested a replacement.There was no patient involvement.

• Brand Name: CONVENTUS PHS SYSTEM
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): CONVENTUS ORTHOPAEDICS, INC.; 10200 73rd avenue north; suite 122; maple grove MN 55369
• Manufacturer (Section G): CONVENTUS ORTHOPAEDICS, INC.; 10200 73rd avenue north; suite 122; maple grove MN 55369
• Manufacturer Contact: kenneth block ; 800 e. campbell road; suite 202; richardson, TX 75081 ; 9724809554
• MDR Report Key: 9107508
• MDR Text Key: 195582520
• Report Number: 3008480376-2019-00008
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141737
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 6650-1
• Device Lot Number: 8226
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/27/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other