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

Catalog Number 8733-7153

Device Problem Fracture (1260)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 06/18/2018

Event Type  Injury  

Manufacturer Narrative

Udi number: na.Without a product return, no product evaluation is able to be conducted.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 tip of a rongeur broke off during surgery.An alternative instrument was not needed to complete the procedure.There was a delay of around 30 minutes in length to retrieve the fragment, but there were no reports of patient injuries.

Manufacturer Narrative

Additional information: (ethnicity).The returned rongeur was evaluated.The top jaw has fractured off of the device.There were no other signs of damage on the device.A review of the manufacturing records did not identify any issues which would have contributed to this event.The labeling was reviewed and found to contain instructions regarding proper device usage.The exact patient conditions (e.G.Hard bone, tight disc space, etc.) are unknown at the time of the event.As such, the cause cannot be conclusively determined.

Event Description

It was reported that the tip of a rongeur broke off during surgery.An alternative instrument was not needed to complete the procedure.There was a delay of around 30 minutes in length to retrieve the fragment, but there were no reports of patient injuries.

• 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: ashley mcpherson ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3034437500
• MDR Report Key: 7765668
• MDR Text Key: 116520614
• Report Number: 3012447612-2018-00655
• 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
• Report Date: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8733-7153
• Device Lot Number: IM00272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2016
• 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
• Patient Outcome(s): Other