MAUDE Adverse Event Report: ZIMMER INC NEXGEN HEADLESS TROCAR DRILL PIN; HWB

Catalog Number 00590102000

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 11/11/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report will be amended when our investigation is complete.

Event Description

It is reported that the surgeon was hammering a pin into the cutting guide when the pin got stuck.As surgeon tried to remove the pin from the guide, the pin broke off.

• Brand Name: NEXGEN HEADLESS TROCAR DRILL PIN
• Type of Device: HWB
• Manufacturer (Section D): ZIMMER INC; p.o. box 708; warsaw IN 46581 0708
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5311864
• MDR Text Key: 33910799
• Report Number: 1822565-2015-02701
• Device Sequence Number: 1
• Product Code: HTY
• 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,health profession
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/20/2015

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: 00590102000
• Device Lot Number: 63165647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/20/2015
• Initial Date FDA Received: 12/18/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/18/2015
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR