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

Model Number 7768-1

Device Problems Break (1069); Entrapment of Device (1212); Detachment of Device or Device Component (2907)

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

Event Date 05/13/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

This mdr is being reported at this time as part of an internal review of past complaints and service records.Due to the incident being in the past, the information that can be obtained from the initial reporter is limited.On (b)(6) 2019, the surgeon removed a ph system.During the surgery, the tip of one solid h10 broke off inside the screw.The removal proceeded with another h10 driver.The complete removal of the ph cage, screws and plate was attained.

Manufacturer Narrative

For the subject h10 driver model, conventus orthopaedics, inc.Reviewed the applicable dhrs (traceability control forms) and dhf (including design change orders).The dhr review found no manufacturing deficiencies.The dhf review established that the driver design had been dimensionally scaled up from an existing driver model used for a different conventus implant system, with inadequate verification and validation conducted for the new model.Additionally, a series of inadequate design changes led to unanticipated dimensional tolerance stack-up.Overall, it has been concluded that the inadequate design of the subject h10 driver model caused the event.This design issue is being addressed through the capa process.

• 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
• MDR Report Key: 9734882
• MDR Text Key: 193404237
• Report Number: 3008480376-2020-00005
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• PMA/PMN Number: K141737
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7768-1
• Device Lot Number: 10255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2019
• Date Manufacturer Received: 05/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 49 YR