MAUDE Adverse Event Report: ZIMMER MANUFACTURING B.V. TRILOGY BONE SCREW; TRAUMA PROSTHESIS

Catalog Number 00625006530

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  Injury  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that a screw broke during surgery, and a piece was unable to be retreived from the patient.

Manufacturer Narrative

This report will be amended when our investigation is complete.Received, not yet evaluated.

Manufacturer Narrative

Complaint sample was evaluated and the reported event was confirmed.The hex head of a bone screw was returned for evaluation.Damage is seen on the outer diameter of the head and shank.Head and shank diameters are conforming to print specifications.Eds semi-quantitative elemental analysis showed that the bone screw sample was consistent with ti-6al-4v alloy.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: TRILOGY BONE SCREW
• Type of Device: TRAUMA PROSTHESIS
• Manufacturer (Section D): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer (Section G): ZIMMER MANUFACTURING B.V.; turpeaux industrial park; route #1 km 123.4 bldg #1; mercedita PR 00715
• Manufacturer Contact: carrie schneider ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5697986
• MDR Text Key: 46513741
• Report Number: 0002648920-2016-00870
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 00625006530
• Device Lot Number: 62784611
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/09/2016
• Initial Date FDA Received: 06/03/2016
• Supplement Dates Manufacturer Received: Not provided; 05/30/2018
• Supplement Dates FDA Received: 07/19/2016; 05/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2014
• 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): Other