MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. BALL TIP PROBE - DUAL ENDED STIFF/FLEXIBLE - STANDARD

Catalog Number	07.02117.001
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a vitality probe tip broke off intra-op.The fractured tip was found on the back table and did not fall into the incision.Another probe was used to complete the case.There were no patient impacts.
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.
Additional Manufacturer Narrative
Inspection: visual inspection revealed that the ball on one tip of the device was fractured off.The shaft of the probe was also bent.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 zimvie¿s control.Potential root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to wear through use over time or multiple sterilization cycles.This event could also be attributed to off-axis forces applied during use.Device usage: this device is used for treatment.A follow-up report will be sent if additional information is obtained that adds value to the relevant content of this report.
Event or Problem Description
It was reported that a vitality probe tip broke off intra-op.The fractured tip was found on the back table and did not fall into the incision.Another probe was used to complete the case.There were no patient impacts.

• Brand Name: BALL TIP PROBE - DUAL ENDED STIFF/FLEXIBLE - STANDARD
• Common Device Name: PROBE
• Manufacturer (Section D): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; westminster CO 80021
• Manufacturer (Section G): ZIMMER BIOMET SPINE INC.; 10225 westmoor dr.; na; westminster CO 80021
• Manufacturer Contact: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 15736016
• Report Number: 3012447612-2022-00249
• Device Sequence Number: 14170303
• Product Code: HXB
• UDI-Device Identifier: 00889024010550
• UDI-Public: (01)00889024010550(10)MC4281504
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2023

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: 07.02117.001
• Device Lot Number: MC4281504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2022
• Supplement Date Received by Manufacturer: 04/18/2023
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 91 KG