MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. PEDICLE PROBE - STRAIGHT LUMBAR LENKE

Catalog Number 07.02077.001

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/15/2017

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 a lumbar probe broke during surgery while the surgeon was preparing the screw hole.The broken piece was removed from the patient.The procedure was completed using an alternative instrument.There were no reports of surgical delay or patient injury associated with this event.

Manufacturer Narrative

The returned probe was evaluated.A section approximately 30mm in length has fractured off the tip.There is also significant material displacement found 10-20mm from the fracture site.The fracture may have been caused by dense bone quality of the patient, off-axis use of the probe, or attempting to alter the trajectory of the probe within the vertebrae.The material displacement on the shaft of the probe most likely occurred due to contact with another hard, metallic material- possibly another instrument in the kit or an adjacent screw in the vertebrae.A review of the manufacturing records did not identify any issues which would have contributed to this event.

• Brand Name: PEDICLE PROBE - STRAIGHT LUMBAR LENKE
• 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: geoffrey gannon ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3034437500
• MDR Report Key: 6739700
• MDR Text Key: 80890777
• Report Number: 3012447612-2017-00327
• Device Sequence Number: 1
• Product Code: HXB
• 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: 12/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2017
• 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: 63040724
• Other Device ID Number: (01)00889024009998(10)63040724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/31/2015
• 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