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 06/13/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 to be bent after it was removed from the pedicle with difficulty during surgery.An alternative probe was used to complete the procedure without reported patient impacts.

Event Description

It was reported that a lenke probe was found to be bent after it was removed from the pedicle with difficulty during surgery.An alternative probe was used to complete the procedure without reported patient impacts.

Manufacturer Narrative

D10 entered in error.Additional information in h3, h4, and h6: method, results, and conclusions codes.The returned curved lenke prove was examined.The tip of the device is bent as reported.It is possible that the curved lenke experienced off-axis forces during insertion which caused the device to bend.A review of the dhr did not find any issues which would have contributed to this event.

• Brand Name: PROBE, LUMBAR, CURVED LENKE
• Type of Device: PROBE
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 8767308
• MDR Text Key: 150262327
• Report Number: 3012447612-2019-00291
• Device Sequence Number: 1
• Product Code: HXB
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 01/23/2020

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: 616944
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/28/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/13/2019
• Initial Date FDA Received: 07/08/2019
• Supplement Dates Manufacturer Received: 12/26/2019
• Supplement Dates FDA Received: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1