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

Catalog Number 07.02077.001

Device Problem Bent (1059)

Patient Problem No Patient Involvement (2645)

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 lenke probe was found bent during a routine set inspection.There were no surgical or patient impacts associated with this issue.

Manufacturer Narrative

The returned lumbar lenke probe was evaluated.The evaluation showed that the tip is bent.The cause of failure cannot be determined at this time as the conditions of use when the device failed are unknown.Bending may occur due to dense bone quality of the patient, off-axis use of the probe, attempting to alter the trajectory of the probe within 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: 7331371
• MDR Text Key: 102211271
• Report Number: 3012447612-2018-00252
• 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: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 07.02077.001
• Device Lot Number: 63041036
• Other Device ID Number: (01)00889024009998(10)63041036
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/28/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2015
• 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