MAUDE Adverse Event Report: ZIMMER BIOMET SPINE INC. SET SCREW DRIVER; SCREWDRIVER

Catalog Number	230H4001
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 3 tether set screw drivers with fractured tips were received at a warehouse from a hospital.The hospital did not provide any patient or surgical information with the returned parts.The sales rep for the hospital was contacted and confirmed there were no patient impacts.This is report three of three for this event.
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.Reference reports 3012447612-2022-00177 through 3012447612-2022-00179.
Additional Manufacturer Narrative
Device evaluation: visual inspection revealed the tips of all three returned drivers are 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 parts were likely conforming when they left zimvie 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 3 tether set screw drivers with fractured tips were received at a warehouse from a hospital.The hospital did not provide any patient or surgical information with the returned parts.The sales rep for the hospital was contacted and confirmed there were no patient impacts.This is report three of three for this event.

• Brand Name: SET SCREW DRIVER
• Common Device Name: SCREWDRIVER
• 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: 15032474
• Report Number: 3012447612-2022-00179
• Device Sequence Number: 6929748
• Product Code: HXX
• UDI-Device Identifier: 00887868227431
• UDI-Public: (01)00887868227431(10)313113
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2023

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: 230H4001
• Device Lot Number: 313113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2022
• Supplement Date Received by Manufacturer: 01/01/2023
• Initial Report FDA Received Date: 07/15/2022
• Supplement Report FDA Received Date: 01/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2020
• 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