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	Foreign Body In Patient (2687)
Date of Event	06/04/2021
Type of Reportable Event	Serious Injury
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 surgeon was using a lenke probe in an aggressive manner intra-operatively when creating the pathway for a pedicle screw due to the patient's difficult anatomy and hard bone when the tip of the probe broke off.The surgeon chose to leave the piece in place since it was encased in the bony anatomy and would not affect the patient.A different probe was used to complete the surgery without further patient impacts.
Additional Manufacturer Narrative
Additional information in h6: component, investigation type, findings, and conclusions.This report is relaying additional information.Device evaluation: visual inspection of the device shows the end has snapped off.Potential cause root cause was unable to be determined.This event could possibly be attributed to wear through use over time or multiple sterilization cycles.It could also be attributed to the hardness of the patient's bone.Dhr review per dhr review, the part was likely conforming when it left zimmer biomet control.Device use this device is used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.
Event or Problem Description
It was reported that the surgeon was using a lenke probe in an aggressive manner intra-operatively when creating the pathway for a pedicle screw due to the patient's difficult anatomy and hard bone when the tip of the probe broke off.The surgeon chose to leave the piece in place since it was encased in the bony anatomy and would not affect the patient.A different probe was used to complete the surgery without further patient impacts.

• 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: 12096617
• Report Number: 3012447612-2021-00225
• Device Sequence Number: 3819804
• Product Code: HXB
• UDI-Device Identifier: 00889024009943
• UDI-Public: (01)00889024009943(10)63040721
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 07.02072.001
• Device Lot Number: 63040721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/07/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 06/30/2021
• Supplement Report FDA Received Date: 07/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other