MAUDE Adverse Event Report: ZIMMER BIOMET ZIMMER BIOMET DVR CROSSLOCK VOLA; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COM

Device Problems Material Too Rigid or Stiff (1544); Device-Device Incompatibility (2919); Material Integrity Problem (2978)

Patient Problem Failure of Implant (1924)

Event Date 08/13/2021

Event Type  Injury  

Event Description

Zimmer biomet dvr crosslock anatomic volar plating system used.During index surgery, it was noted that the drill bits were mismatched in size to the drill guides such that the drill bits were tight and generated metal debris.The drill bit part number was verified as being correct and examination of the drill bit through unused plates indicated that the drill bits were tighter than typical tolerances.The patient subsequently had failure of the construct requiring a revision surgery.Lot number of the drill bit was not noted.Instrumentation lot number recorded as "2 224 5".Fda safety report id # (b)(4).

• Brand Name: ZIMMER BIOMET DVR CROSSLOCK VOLA
• Type of Device: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT, METAL COM
• Manufacturer (Section D): ZIMMER BIOMET
• MDR Report Key: 12711558
• MDR Text Key: 279099147
• Report Number: MW5105003
• Device Sequence Number: 1
• Product Code: LXT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR