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

Catalog Number	07.02072.001
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/01/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: PROBE
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 8940510
• Report Number: 3012447612-2019-00356
• Device Sequence Number: 2520807
• Product Code: HXB
• UDI-Device Identifier: 00889024009943
• UDI-Public: (01)00889024009943(10)103784
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 08/02/2019
• Supplement Date Received by Manufacturer: 04/21/2020
• Initial Report FDA Received Date: 08/28/2019
• Supplement Report FDA Received Date: 04/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1