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

Model Number 7798-1

Device Problem Break (1069)

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

Event Date 02/03/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is in progress.Follow-up report(s) will be submitted upon obtaining any additional information.Conventus orthopaedics, inc.Attempted to submit this mdr on february 26, 2020 at 4:12pm.However, a new (b)(6) account needed to be created and was not approved until (b)(6) 2020.As such, this mdr is being submitted late.

Event Description

On (b)(6) 2020, the surgeon removed ph system hardware.During the surgery, the tip of two 120mm h10 drivers and one 160mm h10 driver broke off into the heads of the screws.Conventus orthopaedics, inc.Is submitting three separate mdrs for each of these three breakage events.This mdr is regarding the 160mm h10 driver (model no.7798-1).

• 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
• Manufacturer (Section G): CONVENTUS ORTHOPAEDICS, INC.; 10200 73rd avenue north; suite 122; maple grove, mn
• Manufacturer Contact: kenneth block ; 800 e. campbell road; suite 202; richardson, tx ; 4809554
• MDR Report Key: 9826327
• MDR Text Key: 221303345
• Report Number: 3008480376-2020-00008
• 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
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/12/2020

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: 7798-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2020
• Initial Date FDA Received: 03/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 24 YR
• Patient Weight: 66