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

Catalog Number 8733-7183

Device Problem Fracture (1260)

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

Event Date 01/24/2023

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 timberline rongeur broke when trying to clear the disc space intra-operatively.A different option was used to complete the case.There was no patient harm and no surgery delay.

Manufacturer Narrative

Inspection: the returned device matches the information in the complaint file and was examined.Visual inspection revealed that the top jaw has fractured from the driving arm of the device, making it no longer functional.The jaw is no longer attached from the top slide which causes the jaw to not open/close when the handle is actuated.Dhr review: the dhr was reviewed.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left zimvie¿s control.Potential root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to wear through use over time or multiple sterilization cycles.Device usage: this device is used for treatment.A follow-up report will be sent if additional information is obtained that adds value to the relevant content of this report.

Event Description

It was reported that the tip of a timberline rongeur broke when trying to clear the disc space intra-operatively.A different option was used to complete the case.There was no patient harm and no surgery delay.

• 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: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 16397249
• MDR Text Key: 309897528
• Report Number: 3012447612-2023-00040
• Device Sequence Number: 1
• Product Code: HTX
• UDI-Device Identifier: 00888480666332
• UDI-Public: (01)00888480666332(10)IM00176
• 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
• Report Date: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8733-7183
• Device Lot Number: IM00176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/24/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/04/2015
• 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: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic