MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. PITUITARY RONGEUR BLACK 3MM LATERAL

Catalog Number 8733-7153

Device Problem Bent (1059)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

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.

Event Description

It was reported that the tip of a rongeur was found bent after the cleaning and decontamination process was performed.There were no surgical or patient impacts associated with event.

Manufacturer Narrative

The returned rongeur was examined.The jaw was found to have fracture near the pivot joint.The cause cannot be determined since it is unknown how the device was being used or handled at the time of the breakage.A review of the dhr did not identify any manufacturing related issues which would have contributed to this event.The labeling was reviewed and found to contain instructions regarding proper device usage.

• Brand Name: PITUITARY RONGEUR BLACK 3MM LATERAL
• 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: 7191191
• MDR Text Key: 97753289
• Report Number: 3012447612-2018-00072
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 8733-7153
• Device Lot Number: L561348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2012
• 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