MAUDE Adverse Event Report: ZIMMER BIOMET, INC. DVR CROSSLOCK LOCK SCREW SQUARE 2.7MM X 14MM; APPLIANCE, FIXATION

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem Tissue Damage (2104)

Event Date 08/29/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).Concomitant medical product - dvr lock standard r, cat#: 131812050 lot#: ni.Product is currently not expected to return to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up medwatch will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2017-07368, 0001825034-2017-07369, 0001825034-2017-07370, 0001825034-2017-07371.

Event Description

It was reported that the patient underwent an open reduction internal fixation right wrist fracture repair, and during the fixation of the plate, there was difficulty threading the screws into the bone.This caused the surgeon to drill wider holes in the patient's bone to get the screws to thread and seat.The procedure was successfully completed with the same plate and screws and with minimal delay.

Manufacturer Narrative

Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.

• Brand Name: DVR CROSSLOCK LOCK SCREW SQUARE 2.7MM X 14MM
• Type of Device: APPLIANCE, FIXATION
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; warsaw IN 46582
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6899646
• MDR Text Key: 87587785
• Report Number: 0001825034-2017-07372
• Device Sequence Number: 1
• Product Code: LXT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK112345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: N/A
• Device Catalogue Number: 131227114
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/16/2018
• 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): Required Intervention
• Patient Age: 62 YR