MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. VITAL MIS P.A.T. TAP STYLUS; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number	N/A
Medical Device Problem Code	Inadequate User Interface (2958)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Inspection visual inspection reveals that the pedicle access tool tap is fractured at the threads.Potential cause the cause of the damage cannot be determined at this time since there is no information available regarding how the instruments were being used or handled at the time of the damage.Dhr review per dhrs review, the part was likely conforming when it left zimmer biomet control.Device use this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
Event or Problem Description
It was reported that a tap did not provide tactile feedback for the surgeon to gauge depth with during surgery.However, device evaluation by the manufacturer found that the tap was fractured.There were no patient impacts.

• Brand Name: VITAL MIS P.A.T. TAP STYLUS
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• MDR Report Key: 11577744
• Report Number: 3012447612-2021-00110
• Device Sequence Number: 4150516
• Product Code: LXH
• UDI-Device Identifier: 00887868309816
• UDI-Public: (01)00887868309816(10)122680
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 03/26/2021

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 Model Number: N/A
• Device Catalogue Number: 850M3000
• Device Lot Number: 122680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2020
• Initial Report FDA Received Date: 03/26/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1