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

Catalog Number 07.02072.001

Device Problem Fracture (1260)

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

Event Date 08/01/2019

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 the tip of a curved lenke probe broke off and became stuck in the pedicle during the procedure.The surgeon was able to removed the stuck piece without incident or patient impact.

Manufacturer Narrative

Additional information in h3 and h6: method, results, and conclusions.The returned probe was evaluated.The tip was confirmed to have fractured off as reported.The cause is likely attributed to off-axis forces placed on the device during use, which overcame the device's capabilities and led to the fracture.A review of the dhr did not identify any issues that would have contributed to this event.The labeling provides instructions regarding proper device usage.

Event Description

It was reported that the tip of a curved lenke probe broke off and became stuck in the pedicle during the procedure.The surgeon was able to removed the stuck piece without incident or patient impact.

• Brand Name: PEDICLE PROBE - CURVED LUMBAR LENKE
• Type of Device: PROBE
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 8940510
• MDR Text Key: 155930367
• Report Number: 3012447612-2019-00356
• Device Sequence Number: 1
• Product Code: HXB
• UDI-Device Identifier: 00889024009943
• UDI-Public: (01)00889024009943(10)103784
• 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: 04/21/2020

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: 07.02072.001
• Device Lot Number: 103784
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/02/2019
• Initial Date FDA Received: 08/28/2019
• Supplement Dates Manufacturer Received: 04/21/2020
• Supplement Dates FDA Received: 04/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1