MAUDE Adverse Event Report: ZIMMER SPINE, INC. PROVISIONAL PLUG DRIVER-LONG

Model Number 777-03

Device Problems Bent (1059); Break (1069); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/11/2014

Event Type  malfunction  

Event Description

During surgery an inserter bent and the tip broke off inside a set screw.The surgeon was unable to remove the broken piece and the set screw could not be final tightened.

Manufacturer Narrative

The specific cause of the broken inserter could not be determined.The most likely cause is related to surgical context.

• Brand Name: PROVISIONAL PLUG DRIVER-LONG
• Type of Device: PROVISIONAL PLUG DRIVER-LONG
• Manufacturer (Section D): ZIMMER SPINE, INC.; 7375 bush lake rd.; minneapolis MN 55439
• Manufacturer Contact: scott lapointe ; 7375 bush lake rd.; minneapolis, MN 55439 ; 9528325600
• MDR Report Key: 4113692
• MDR Text Key: 4920568
• Report Number: 2184052-2014-00178
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 08/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 777-03
• Device Catalogue Number: 777-03
• Device Lot Number: 56FP
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/25/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/20/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1