MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. 5 MM RONGEUR

Catalog Number 60341

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/21/2017

Event Type  malfunction  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

Event Description

It was reported that the screw component on a rongeur broke during surgery.The procedure was completed using an alternative instrument.There were no reports of patient impacts associated with this event.

Manufacturer Narrative

Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.

Manufacturer Narrative

Additional information: the returned device was evaluated.The connection pin fractured, likely as a result of repetitive normal usage.A review of the dhr did not identify any issues which would have contributed to this event.

• Brand Name: 5 MM RONGEUR
• Type of Device: RONGEUR
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; na; westminster CO 80021
• Manufacturer Contact: geoffrey gannon ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3034437500
• MDR Report Key: 7127579
• MDR Text Key: 95457991
• Report Number: 3012447612-2017-00694
• Device Sequence Number: 1
• Product Code: HTX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PEXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 60341
• Device Lot Number: 044154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1