MAUDE Adverse Event Report: BIOMET ORTHOPEDICS UNKNOWN DVR PLATE; PROSTHESIS, NAIL

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Neurological Deficit/Dysfunction (1982)

Event Date 11/15/2010

Event Type  Injury  

Manufacturer Narrative

(b)(4).Repot source, literature - j.Chappuis, p.Boute & p.Putz (2010) dorsally displaced extra-articular distal radius fractures fixatio: dorsal im nailing versus volar plating.A randomized controlled trial.Orthopaedics & traumatology: surgery & research (2011) 97, 471¿478.Http://www.Sciencedirect.Com/science/article/pii/s187705681100096x.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

It was reported that patient had neural deficit.Clinical and radiographic results were analyzed the early postoperative period.

• Brand Name: UNKNOWN DVR PLATE
• Type of Device: PROSTHESIS, NAIL
• Manufacturer (Section D): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): BIOMET ORTHOPEDICS; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6795806
• MDR Text Key: 82757109
• Report Number: 0001825034-2017-06383
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: N/A
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other