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

Catalog Number	07.02067.001
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 or Problem Description
It was reported that the tip of the probe broke and was stuck in the pedicle.The tip was retrieved.Additional bone was removed around the tip in order to remove it, but there were no changes to the planned treatment and there were no reported patient impacts.
Event or Problem Description
It was reported that the tip of the probe broke and was stuck in the pedicle.The tip was retrieved.Additional bone was removed around the tip in order to remove it, but there were no changes to the planned treatment and there were no reported patient impacts.
Additional Manufacturer Narrative
The returned probe was examined.The tip of the probe was fractured.The cause of this event can likely be attributed to the patient having osteoporotic bone which would lead to more difficult bone prep.A review of the dhr did not find any issues which would have contributed to the event.

• Brand Name: PEDICLE PROBE - STRAIGHT LUMBAR
• Common Device Name: PROBE
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 9009540
• Report Number: 3012447612-2019-00386
• Device Sequence Number: 16810701
• Product Code: HXB
• UDI-Device Identifier: 00889024009912
• UDI-Public: (01)00889024009912(10)63040742
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2020

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: 07.02067.001
• Device Lot Number: 63040742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/15/2019
• Supplement Date Received by Manufacturer: 05/01/2020
• Initial Report FDA Received Date: 09/12/2019
• Supplement Report FDA Received Date: 05/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1