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

Catalog Number 8733-7183

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 10/16/2017

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 jaw of a rongeur was found to be misaligned after cleaning and sterilization.There were no surgical or patient impacts associated with this event.

Manufacturer Narrative

Additional information: lot number; the returned rongeur was functionally and visually evaluated.When the handles were actuated, the jaw opened and closed as expected.However, the upper jaw was found to be slightly bent so the teeth did not align.The cause is likely attributed to damage from use or handling.A review of the manufacturing records did not identify any issues which would have contributed to this event.

• Brand Name: RONGEUR PITUITARY CER BLACK SERRATED 3MM
• 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: 7026322
• MDR Text Key: 92856649
• Report Number: 3012447612-2017-00654
• 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: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 8733-7183
• Device Lot Number: IM00077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2014
• 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