MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. STRAIGHT LUMBAR LENKE VITALITY; PROBE

Catalog Number 07.02077.001

Device Problem Fracture (1260)

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

Event Date 09/14/2021

Event Type  malfunction  

Manufacturer Narrative

Inspection the product was not returned and no photos were provided.Device evaluation could not be completed.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 zimmer biomet¿s control.Potential root cause possible contributors to this event could be dense bone quality of the patient, off-axis use of the probe, or attempting to alter the trajectory of the probe within the vertebrae.Since the complaint was reported outside of a case and no event was reported about how the device bent, the cause cannot be conclusively determined.Device usage this device is used for treatment.

Event Description

It was reported that the tip of a straight lumbar lenke probe snapped off while trying to remove it from the patient's bone; the patient had very hard bone and the probe was difficult to remove.The tip was recovered and there was no reported patient harm.

• Brand Name: STRAIGHT LUMBAR LENKE VITALITY
• Type of Device: PROBE
• 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: 12677743
• MDR Text Key: 277928259
• Report Number: 3012447612-2021-00409
• Device Sequence Number: 1
• Product Code: HXB
• UDI-Device Identifier: 00889024009998
• UDI-Public: (01)00889024009998(10)102916
• 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: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07.02077.001
• Device Lot Number: 102916
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2017
• 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