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

Model Number PH-S

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/06/2019

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, while implanting the ph cage, the surgeon was inserting a solid locking screw through the bottom left hole of the short locking plate when the screw went through the plate and into the bone.The surgeon used a drill tower on the targeting jig, and was hand-tightening the screw when it went through the plate.The surgeon had to remove all the screws, except for the distal screw, and move the plate to the side in order to extract the suspect screw.The surgeon then re-implanted the screws (except for the suspect screw; the suspect hole was also not used), and completed the surgery.

• 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: 9153793
• MDR Text Key: 194648210
• Report Number: 3008480376-2019-00007
• 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
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/01/2019

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
• Device Operator: Health Professional
• Device Model Number: PH-S
• Device Lot Number: 9395
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/06/2019
• Initial Date FDA Received: 10/03/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR