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

Catalog Number 730M1004

Device Problem Material Twisted/Bent (2981)

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

Event Date 04/18/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 during surgery while preparing the screw hole.An alternative probe was used to complete the procedure without reported patient impacts.

Manufacturer Narrative

Additional information: the returned lumbar curved lenke probe was evaluated.Visual inspection revealed that the tip is bent.Based on the event description and the nature of the failure, the curved lenke possibly experienced higher than normal forces which caused the device to bend during surgery.Additionally, it is unknown what condition of bone that the patient had as hard bone could also have contributed to this event.A review of the manufacturing records did not identify any issues which would have contributed to this event.The labeling was reviewed and found to contain instructions regarding proper device usage.

Event Description

It was reported that a lenke probe bent during surgery while preparing the screw hole.An alternative probe was used to complete the procedure without reported patient impacts.

• Brand Name: PROBE, LUMBAR, CURVED 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: ashley mcpherson ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3034437500
• MDR Report Key: 8610084
• MDR Text Key: 145095016
• Report Number: 3012447612-2019-00224
• Device Sequence Number: 1
• Product Code: HXB
• 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,Followup
• Report Date: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 730M1004
• Device Lot Number: 617612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/19/2019
• Initial Date FDA Received: 05/14/2019
• Supplement Dates Manufacturer Received: 10/09/2019
• Supplement Dates FDA Received: 11/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2018
• 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