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); Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)

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

Event Date 02/03/2020

Event Type  malfunction  

Manufacturer Narrative

Conventus orthopaedics, inc.Reviewed the traceability control forms for the h10 driver, then determined that there were no production issues that occurred during packaging, labeling, or receiving of the product.The investigation is in progress.Follow-up report(s) will be submitted upon obtaining any additional information.

Event Description

On (b)(6) 2020, during the ph cage removal surgery, one h10 driver broke off in a screw (either model no.7768-1 or 7036-1), keeping the plate in place until it was lifted off the bone.A small osteotomy was attempted to expose the cage superiorly.The surgeon then loosened the cage and removed it from the humeral head.Conventus orthopaedics, inc.Is submitting two separate mdrs for this event based on the current information.This mdr is regarding the 120 mm h10 solid driver with the model no.7768-1.

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: 9734600
• MDR Text Key: 200434637
• Report Number: 3008480376-2020-00003
• 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: health professional
• 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?: Yes
• 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?: No
• Date Manufacturer Received: 02/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other