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

Catalog Number 07.02072.001

Device Problem Bent (1059)

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

Event Date 01/16/2018

Event Type  malfunction  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

Event Description

It was reported that a lenke probe bent while preparing the screw hole on the left side of s1 during surgery due to the patient's hard bone.An alternative instrument was used to to complete the procedure without any reported patient impacts.

Manufacturer Narrative

The returned probe was evaluated.The tip was confirmed to be bent.The exact cause of failure cannot be determined as there were no problems reported to the distributor by the last doctor to use the instrument.The device was damaged during use and the doctor believed the patient's hard bone may have played a role in the failure though it can not be confirmed.A review of the dhr did not identify any issues which would have contributed to this event.

• Brand Name: PEDICLE PROBE - CURVED 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: 7261241
• MDR Text Key: 99905563
• Report Number: 3012447612-2018-00147
• 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,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07.02072.001
• Device Lot Number: 63040743
• Other Device ID Number: (01)00889024009943(10)63040743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: N/A
• Patient Sequence Number: 1