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

Catalog Number 00625006535

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/12/2015

Event Type  malfunction  

Event Description

It is reported the screw head broke off during implantation.The head of the screw was removed; however, the remainder of the screw could not be retrieved.

Manufacturer Narrative

This report will be amended when our investigation is complete.

• Brand Name: ZIMMER SELF-TAPPING BONE SCREW
• Type of Device: MRA
• Manufacturer (Section D): ZIMMER; turpeaux industrial park; route 1, km. 123.4, bldg. 1; mercedita 00715
• Manufacturer Contact: kevin escapule ; po box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4849950
• MDR Text Key: 5944907
• Report Number: 2648920-2015-00214
• 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: Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/13/2015

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 Expiration Date: 07/31/2023
• Device Catalogue Number: 00625006535
• Device Lot Number: 62437488
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/13/2015
• Initial Date FDA Received: 06/16/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2013
• 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
• Patient Age: 44 YR