MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. STRAIGHT LUMBAR LENKE VITALITY; PROBE

Catalog Number	07.02077.001
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Inspection the product was not returned and no photos were provided.Device evaluation could not be completed.Dhr review the dhr was reviewed.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left zimmer biomet¿s control.Potential root cause possible contributors to this event could be dense bone quality of the patient, off-axis use of the probe, or attempting to alter the trajectory of the probe within the vertebrae.Since the complaint was reported outside of a case and no event was reported about how the device bent, the cause cannot be conclusively determined.Device usage this device is used for treatment.
Event or Problem Description
It was reported that the tip of a straight lumbar lenke probe snapped off while trying to remove it from the patient's bone; the patient had very hard bone and the probe was difficult to remove.The tip was recovered and there was no reported patient harm.

• Brand Name: STRAIGHT LUMBAR LENKE VITALITY
• Common Device Name: PROBE
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 12677743
• Report Number: 3012447612-2021-00409
• Device Sequence Number: 19908046
• Product Code: HXB
• UDI-Device Identifier: 00889024009998
• UDI-Public: (01)00889024009998(10)102916
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/21/2021

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: 07.02077.001
• Device Lot Number: 102916
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2021
• Initial Report FDA Received Date: 10/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1