MAUDE Adverse Event Report: ZIMMER BIOMET SPINE POL TRANS BUTTON LOCK SCREW INSERTER; SCREWDRIVER

Model Number N/A

Device Problem Fracture (1260)

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

Event Date 03/02/2016

Event Type  malfunction  

Manufacturer Narrative

The returned driver was examined and the tip was found to have been broken off, and not stripped as originally reported.There were no indications of manufacturing issues which would have contributed to this event.The device labeling was reviewed and found to contain instructions on the proper usage of the device.

Event Description

It was reported that a driver stripped during use.There was no patient harm or surgical delay associated with this event.However, after the returned device was returned to the manufacturer, it was found that the driver tip fractured.

• Brand Name: POL TRANS BUTTON LOCK SCREW INSERTER
• Type of Device: SCREWDRIVER
• Manufacturer (Section D): ZIMMER BIOMET SPINE; 310 interlocken parkway; suite 120; broomfield CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE; 310 interlocken parkway; suite 120; broomfield CO 80021
• Manufacturer Contact: teresa george ; 310 interlocken parkway; suite 120; broomfield, CO 80021 ; 3034437500
• MDR Report Key: 6024555
• MDR Text Key: 57619839
• Report Number: 3004485144-2016-00278
• Device Sequence Number: 1
• Product Code: HWD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 14-500070
• Device Lot Number: PW11B
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1