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

Catalog Number 8733-7153

Device Problem Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/25/2022

Event Type  malfunction  

Event Description

It was reported that the upper jaw of a timberline pituitary broke off during a surgery.There was no reported patient harm or injury: all pieces of the timberline pituitary were accounted for.

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 in h4 and h6: component, investigation type, findings, and conclusions.Device evaluation: the returned device was examined.Visual inspection revealed the tip of the device is fractured off.Potential cause: root cause was unable to be determined.This event could possibly be attributed to wear through use over time or multiple sterilization cycles.Dhr review: per dhr review, the part was likely conforming when it left zimmer biomet control.Device use this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.

Event Description

It was reported that the upper jaw of a timberline pituitary broke off during a surgery.There was no reported patient harm or injury: all pieces of the timberline pituitary were accounted for.

• 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: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 13685055
• MDR Text Key: 289317517
• Report Number: 3012447612-2022-00056
• Device Sequence Number: 1
• Product Code: HTX
• UDI-Device Identifier: 00888480666141
• UDI-Public: (01)00888480666141(10)L554906
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8733-7153
• Device Lot Number: L554906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male