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)
Date of Event	11/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that two tether set screw drivers fractured during surgery.One driver tip fractured off completely in the set screw and remained implanted in the patient, the other fractured incompletely and was retrieved.This is report one of two for this event.
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.Reference report 3012447612-2022-00312.
Event or Problem Description
It was reported that two tether set screw drivers fractured during surgery.One driver tip fractured off completely in the set screw and remained implanted in the patient, the other fractured incompletely and was retrieved.This is report one of two for this event.
Additional Manufacturer Narrative
Corrections in d4: udi number and h3.Additional information in h4 and h6: component, investigation type, findings, and conclusions.Device evaluation: the returned devices match the information in the complaint file and were examined.Visual inspection revealed that both devices were fractured at the tip.Lot 311982 was not fully fractured off, while lot 313772 was.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.Dhr review: per dhr review, the part was likely conforming when it left zimvie control.Device usage: 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.

• 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: 16023544
• Report Number: 3012447612-2022-00311
• Device Sequence Number: 12512098
• Product Code: HXX
• UDI-Device Identifier: 00887868227431
• UDI-Public: (01)00887868227431(10)311982
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 05/30/2023

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: 311982
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2022
• 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: 12/01/2022
• Supplement Date Received by Manufacturer: 05/30/2023
• Initial Report FDA Received Date: 12/21/2022
• Supplement Report FDA Received Date: 05/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2019
• 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