MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. DRIVER, SET SCREW; DYNESYS TOP-LOADING SPINAL SYSTEM

Catalog Number	07.01296.001
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 a warehouse found a dynesys screw driver with a broken tip during inspection upon return from a hospital.There were no reported patient consequences.
Additional Manufacturer Narrative
Corrections in d4: lot number and udi number.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 a warehouse found a dynesys screw driver with a broken tip, during inspection, upon return from a hospital.There were no reported patient consequences.
Additional Manufacturer Narrative
Corrections in d9 and h3.Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation visual inspection revealed the tip is fractured.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.Dhr review per dhr review, the part was likely conforming when it left zimvie control.Device use 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 warehouse found a dynesys screw driver with a broken tip during inspection upon return from a hospital.There were no reported patient consequences.

• Brand Name: DRIVER, SET SCREW
• Common Device Name: DYNESYS TOP-LOADING SPINAL SYSTEM
• 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: 15130198
• Report Number: 3012447612-2022-00181
• Device Sequence Number: 6473971
• Product Code: NQP
• UDI-Device Identifier: 00889024325388
• UDI-Public: (01)00889024325388(10)P090191
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K133164
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/20/2023

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: 07.01296.001
• Device Lot Number: P090191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/06/2022
• Supplement Date Received by Manufacturer: 07/18/2022; 01/19/2023
• Initial Report FDA Received Date: 07/29/2022
• Supplement Report FDA Received Date: 08/12/2022; 01/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2009
• 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: Unknown