MAUDE Adverse Event Report: ZIMMER ZIMMER SELF-TAPPING BONE SCREW

Catalog Number 00625006535

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/07/2014

Event Type  malfunction  

Event Description

It is reported that the screw fractured while implanting.The fractured portion remains in the patient.

Manufacturer Narrative

Information was receive via medwatch #mw5039382.This report will be amended when our investigation is complete.

Manufacturer Narrative

As described, the product failed to meet specification; however, no product was returned for analysis.These screws are used in treatments.The investigation determined the root cause to be that this manufacturing lot had been made on a specific milling machine, which caused tool marks in the threads, leading to fracture during insertion of the screw.As a result, a recall was initiated for the trilogy screws produced on this specific milling machine.Reference recall (b)(4) for additional details regarding the corrective actions taken.

• Brand Name: ZIMMER SELF-TAPPING BONE SCREW
• Manufacturer (Section D): ZIMMER; route 1, km. 123.4, bldg. 1; turpeaux industrial park; mercedita PR 00715
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4826980
• MDR Text Key: 5839226
• Report Number: 2648920-2015-00203
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00625006535
• Device Lot Number: 62793495
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/06/2015
• Initial Date FDA Received: 06/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1